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Percutaneous sclerotherapy with OK-432 for lymphocele after pelvic or para-aortic lymphadenectomy: preliminary results

Percutaneous sclerotherapy with OK-432 for lymphocele after pelvic or para-aortic... Background: Lymphoceles can result from disruption of lymphatic vessels after surgical procedures in areas with extensive lymphatic networks. Percutaneous catheter drainage with sclerotherapy can be performed for the treat- ment of lymphoceles. OK-432 has been used to treat benign cysts, such as lymphangioma and ranula. Therefore, we aimed to report the efficacy and safety of sclerotherapy using OK-432 for postoperative lymphoceles. This study retro - spectively analyzed 16 patients who underwent sclerotherapy using OK-432 for postoperative pelvic and para-aortic lymphoceles between April 1, 2012, and March 31, 2020. All the patients underwent percutaneous drainage before sclerotherapy. The indications for sclerotherapy were persistent drainage tube output of greater than 50 mL per day and recurrent lymphoceles after percutaneous drainage. If less than 20 mL per day was drained after sclerotherapy, the tube was removed. When the drainage tube output did not decrease to less than 20 mL per day after the first sclerotherapy, the second sclerotherapy was performed 1 week later. Technical success was defined as the completion of drainage and sclerotherapy procedures. Clinical success was defined as the resolution of the patient’s symptoms resulting from lymphoceles without surgical intervention. This study also evaluated the complications of sclerother- apy and their progress after sclerotherapy. Results: The mean initial lymphocele size and drainage duration after sclerotherapy were 616 mL and 7.1 days, respectively. The technical success rate and clinical success rate were 100% and 93%, respectively. Thirteen patients were treated by one-session sclerotherapy and three patients were treated by two-session sclerotherapy. Minor com- plications (fever) were observed in eight patients (50%). A major complication (small bowel fistula) was observed in one patient (7%). No recurrence of lymphoceles was observed during the mean follow-up period of 17 months. Conclusion: Sclerotherapy with OK-432 is an effective therapeutic method for postoperative lymphoceles. Although most complications are minor, a small bowel fistula was observed in one patient. Keywords: OK-432, Sclerotherapy, Lymphocele vessels after surgical procedures in areas with extensive Background lymphatic networks. Lymphoceles can cause hydro- Lymphoceles are postoperative cystic collections of nephrosis, infection, abdominal pain, leg edema, and lymph fluid surrounded by a fibrous wall lacking epi - deep venous thrombosis (Karcaaltincaba & Akhan, thelium. They can result from disruption of lymphatic 2005a; vanSonnenberg et  al., 1986). The incidence rate of symptomatic lymphoceles ranges from 2% to 9%, *Correspondence: y-ono@radiol.med.osaka-u.ac.jp depending on the type of surgery (Goßler et  al., 2021; Department of Diagnostic and Interventional Radiology, Osaka University Heers et  al., 2015; Zikan et  al., 2015). Asymptomatic Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, Japan lymphoceles resolve spontaneously without treatment © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http:// creat iveco mmons. org/ licen ses/ by/4. 0/. Kashiwagi et al. CVIR Endovascular (2022) 5:55 Page 2 of 7 (Dodd et  al., 1970); however, symptomatic lympho- Material and Methods celes might require treatment. Treatment options for Patients symptomatic lymphoceles include percutaneous fine- This study was approved by the Institutional Review needle aspiration, percutaneous catheter drainage, Board of Osaka University Hospital, Japan. We percutaneous catheter drainage with sclerotherapy, reviewed the electronic medical records of all patients lymphatic embolization, and surgery (Ten Hove et  al., who underwent percutaneous drainage of postopera- 2021). Minimally invasive treatment has become the tive pelvic and para-aortic lymphoceles between April first treatment option (Ten Hove et  al., 2021). Percu - 1, 2012, and March 31, 2020, at our institution. A total taneous fine-needle aspiration is no longer performed of 50 lymphoceles in 45 patients (5 male, 40 female) due to its high recurrence rate, the need for frequent were treated by percutaneous drainage. There were 45 punctures, and infection risk (Jensen et  al., 1986; Kar- patients, 26 patients who were completely treated with caaltincaba & Akhan, 2005b). Lymphatic embolization percutaneous drainage alone and 3 patients who were has been reported as a treatment option because of its completely treated with sclerotherapy using minocy- high success and low recurrence rates. However, lym- cline alone were excluded from the study. Finally, 16 phatic embolization is often selected when the patient patients who underwent sclerotherapy with OK-432 does not respond to previous treatment (e.g., percuta- were included in this retrospective study. Sixteen neous catheter drainage with or without sclerotherapy), patients were diagnosed with 16 lymphoceles. Fifteen and this procedure requires a learning curve (Ten Hove patients underwent surgery for gynecological cancer, et  al., 2021; Addo et al., 2018; Baek et al., 2016). In the and one patient underwent surgery for rectal cancer. past, external drainage and internal marsupialization Patient characteristics are shown in Table  1. The diag - via laparotomy or laparoscopy were the treatment of nosis of lymphocele was based on clinical course and choice. However, surgery has a relatively high risk of imaging findings. Lymphocele infection was confirmed complications (e.g., injury to the bladder, ureter, and by fever, elevated white blood cell count and C-reactive ileus) and long hospitalization (Ten Hove et  al., 2021; protein level, or bacterial culture of the drainage fluid. Gill et  al., 1995). Currently, percutaneous catheter None of the patients had previously received surgi- drainage with or without sclerotherapy is often chosen cal treatment for lymphoceles, but one patient was for symptomatic lymphoceles and has achieved a high treated with OK-432 after failing to respond to sclero- success rate (Ten Hove et  al., 2021). Various agents therapy with ethanol, povidone-iodine, fibrin glue, and have been used for sclerotherapy, including povidone- minocycline. iodine, ethanol, tetracycline, bleomycin, and fibrin glue (Alago et al., 2013; Akhan et al., 2007; Chin et al., 2007; Filippiadis et  al., 2017). However, a consensus regard- Table 1 Characteristics of the patients ing effective sclerosing agents for lymphoceles has not Total cases (n = 16) yet been reached. OK-432 (Picibanil , Chugai Pharma- ceutical Co., Ltd., Tokyo, Japan) is a lyophilized mixture Mean age, years 56 (34-71) of a low-pathogenic strain of Streptococcus pyogenes Sex (Su) incubated with benzylpenicillin. It is widely used Male 0 to treat malignant pleural effusions, chylothorax, and Female 16 pneumothorax (Kasahara et  al., 2006; Ono et  al., 2010; Cancer types Takeda et  al., 2006). OK-432 sclerotherapy has been Gynecological cancer 15 reported to be effective in the treatment of benign Rectal cancer 1 cysts, such as lymphangioma and ranula (Ogita et  al., Site of lesion 1994; Roh, 2006). The mechanism of action of OK-432 Pelvic 14 on benign cysts is to immediately induce inflammation, Para-aortic 2 causing inflammatory cells to invade the cyst and cause Primary symptoms the cyst to adhere (Fujino et  al., 2003). Although scle- Fever 4 rotherapy with OK-432 for postoperative lymphoceles Abdominal pain 5 in the inguinal or axillary region has been reported Hydronephrosis 6 (Uyulmaz et  al., 2020), there have been no reports of Lower extremity edema 1 sclerotherapy with OK- 432 for lymphoceles after pelvic Infection of lymphoceles 8 and para-aortic lymphadenectomy in English literature. Previous treatment 1 This study aimed to report the efficacy and safety of One patient was treated with ethanol, povidone-iodine, fibrin glue, and sclerotherapy of lymphoceles using OK-432. minocycline before sclerotherapy with OK-432 K ashiwagi et al. CVIR Endovascular (2022) 5:55 Page 3 of 7 Procedures patients were observed by clinical follow-up and abdomi- All the patients underwent percutaneous drainage before nal CT. Technical success was defined as the completion sclerotherapy. Two patients underwent repeat drain of drainage and sclerotherapy procedures resulting in placement due to recurrent lymphoceles after initial adequate decrease of the drainage tube output and tube drain removal. Percutaneous drainage was performed removal. Clinical success was defined as the resolution under ultrasound or computed tomography (CT) guid- of the patient’s symptoms resulting from lymphoceles ance by an experienced interventional radiologist. A 7- to without surgical intervention. The estimated lymphocele 8.5-French pigtail catheter (Dawson-Mueller Drainage volume was calculated by CT volumetry using a software Catheters, Cook Medical) was placed into the cavity. If Aquarius iNtuition Edition version 4.4.13 . Complica- there was residual fluid, the drainage tube was exchanged tions were evaluated according to the classification of as needed to ensure sufficient drainage. Fifteen patients the CIRSE classification system (Filippiadis et  al., 2017). underwent sclerotherapy because of persistent drain- u Th s, Major complications were defined as grade 2 to age tube output of greater than 50 mL/day or recurrent grade 6. Minor complications were defined as grade 1. lymphoceles after percutaneous drainage. One patient underwent initial percutaneous drainage and consecu- Statistical analysis tive sclerotherapy in one session, based on the operator’s Data analyses were performed with EZR (Saitama Medi- judgment. Klinische Einheit (KE) is used to express the cal Center, Jichi Medical University, Saitama, Japan), preparation dosage. One KE of OK-432 contains 0.1 mg of which is a graphical user interface for R (The R Foun - dried cocci. OK-432 solution was prepared by dissolving dation for Statistical Computing, Vienna, Austria). The one KE of OK-432 in 10 mL of half diluted contrast media results are presented as mean (standard deviation [SD]) (Urografin-60; Bayer, Leverkusen, Germany) with saline. for quantitative variables and frequency (percentage) for After emptying the cavity, a cavitogram was obtained qualitative variables. In the statistical analysis, Pearson’s to exclude leakage from the lymphoceles (Fig.  1). The correlation coefficient was used to assess the correlation OK-432 solution was injected into the cavity and left between the initial lymphocele size and drainage dura- there for 2 hours, after which catheter was allowed to tion after sclerotherapy. Statistical significance was con - drain. The volume of OK-432 used for sclerotherapy was sidered at p-value of < 0.05. determined based on estimated volume of the residual cavity by a cavitogram immediately before sclerotherapy. Results If the drainage tube drained less than 20 mL per day after The mean initial lymphocele size was 616 (range, sclerotherapy, the tube was removed. When the drain- 76–3295) mL. The mean drainage duration after scle- age tube output did not decrease to less than 20 mL per rotherapy was 7.1 (Karcaaltincaba & Akhan, 2005a; day on the sixth day after the first sclerotherapy, the sec - vanSonnenberg et al., 1986; Goßler et al., 2021; Heers ond OK-432 sclerotherapy were performed on the sev- et  al., 2015; Zikan et al., 2015; Dodd et al., 1970; Ten enth day. All procedures were performed under local Hove et  al., 2021; Jensen et  al., 1986; Karcaaltincaba anesthesia during hospitalization. After discharge, the & Akhan, 2005b; Addo et  al., 2018; Baek et  al., 2016; Fig. 1 a Contrast-enhanced computed tomography (CT ) after gynecological cancer surgery in a 60-year-old woman presenting with left low leg lymphedema. CT shows left pelvic lymphocele (white arrow). b Cavitogram shows no leakage of the lymphocele Kashiwagi et al. CVIR Endovascular (2022) 5:55 Page 4 of 7 Fig. 2 Correlations between initial lymphocele size and drainage duration Table 2 Results of percutaneous sclerotherapy Table 3 Cases of sclerotherapy Total cases (n = 16) Case Number of Volume of OK-432 Drainage Infection sessions output Mean initial lymphocele size, mL 616 (76–3295) (mL/24 h) Mean drainage duration after sclerotherapy, days 7.1 (1–20) 1 2 2KE+4KE 50 – Mean volume of OK-432, KE 1.9 (1–4) 2 2 2KE+2KE 360 – Number of sessions 3 1 2KE 100 – One 13 4 1 2KE 130 – Two 3 5 1 2KE 200 Yes Technical success, n (%) 16 (100%) 6 1 2KE 120 Yes Clinical success, n (%) 15 (93%) 7 1 2KE 100 Yes Complication 8 1 2KE – – Major 1 9 1 2KE 100 Yes Minor 8 10 1 1KE 280 – The Klinische Einheit (KE) is used to express the dosage of preparation; 1 KE of 11 1 1KE 30 Yes OK-432 contains 0.1 mg of dried cocci 12 1 1KE 25 Yes 13 1 2KE 70 Yes 14 1 1KE 100 Yes Gill et al., 1995; Alago et al., 2013; Akhan et al., 2007; 15 2 2KE+2KE 810 – Chin et  al., 2007; Filippiadis et  al., 2017; Sacks et  al., 16 1 2KE 60 Yes 2003; Kasahara et  al., 2006; Ono et  al., 2010; Takeda et  al., 2006) days. Pearson’s correlation coefficient Drainage tube output the day before the first sclerotherapy showed moderately negative correlation (r = − 0.414) The case was treated with OK-432 after failing to respond to sclerotherapy with other sclerosing agents between the initial lymphocele size and drainage The case underwent initial percutaneous drainage and consecutive duration after sclerotherapy, but the association was sclerotherapy in one session not statistically significant (p = 0.113) (Fig .  2). The The cases were treated for recurrent lymphoceles after percutaneous drainage mean injection volume of OK-432 was 1.9 KE. The technical success rate was 100% (16/16). The clini- cal success rate was 93% (15/16). One patient with (7%). One month after the sclerotherapy, the patient hydronephrosis did not improve. Three patients presented with fever. CT revealed an abscess in the were treated by two-session sclerotherapy (Table  2). pelvis. Percutaneous drainage was performed, and The patients’ lymphoceles were not infected and the a cavitogram showed a small bowel fistula (Fig.  3). drainage tube output tended to be high volume the Consequently, the small bowel fistula was resolved day before the first sclerotherapy (Table  3). Minor only by percutaneous drainage. No recurrence of complications (grade 1) were observed in eight lymphoceles was observed during the mean follow- patients (50%), who presented with fever. Major up period of 17 (range, 2.5–49.8) months. complication (grade 3) was observed in one patient K ashiwagi et al. CVIR Endovascular (2022) 5:55 Page 5 of 7 Fig. 3 a Contrast-enhanced computed tomography (CT ) after gynecological cancer surgery in a 69-year-old woman presenting with abdominal pain. CT shows pelvic lymphocele. b Cavitogram shows lymphocele reduction, sclerotherapy with OK-432 was performed. c One month after sclerotherapy, CT showed abscess in the pelvic (white arrow). d Cavitogram shows a small bowel fistula (white arrow) Discussion with ethanol or povidone-iodine reported previously A variety of sclerosing agents have been used for sclero- (Table  4). However, the mean drainage duration of therapy of lymphoceles in previous reports (Alago et  al., OK-432 sclerotherapy (7.1 days) was trend to be shorter 2013; Akhan et  al., 2007; Chin et  al., 2007; Filippiadis than that of ethanol and povidone-iodine sclerotherapy et  al., 2017). This study is the first reports of sclerother - (Table 4). Sclerotherapy with ethanol or povidone-iodine apy with OK- 432 for lymphoceles after pelvic and para- was performed in multiple sessions (Sawhney et al., 1996; aortic lymphadenectomy. In our cohort, the first patient Zuckerman & Yeager, 1997; Montalvo et al., 1996; Rivera initially underwent sclerotherapy using various agents et  al., 1996), whereas sclerotherapy with OK-432 in this without effect. Therefore, we tried sclerotherapy using study was often performed in one session (81%, 13/16), OK-432. This study achieved a 93% clinical success rate. which may have resulted in a shorter drainage period. This result is similar to the success rate of sclerotherapy Because OK-432 is a strong irritant, this study suggests Table 4 Studies of various sclerotherapies References Agent Number of Mean drainage duration after Success rate, % lymphoceles sclerotherapy, days Akhan et al. (Akhan et al., 2007) ethanol 50 11.8 91 Sawhney et al. (Sawhney et al., 1996) ethanol 14 36 93 Zuckerman and Yeager. (Zuckerman & ethanol 32 19 94 Yeager, 1997) Alago et al. (Alago et al., 2013) povidone-iodine 18 13 100 Montalvo et al. (Montalvo et al., 1996) povidone-iodine 17 36 82 Rivera et al. (Rivera et al., 1996) povidone-iodine 19 13 62.5 Our study OK-432 16 7.1 93 Kashiwagi et al. CVIR Endovascular (2022) 5:55 Page 6 of 7 Abbreviations that sclerotherapy with OK-432 can be completed in one CT: Computed tomography; KE: Klinische Einheit. session. Three patients who underwent two sessions of sclerotherapy were not infected and the drainage tube Acknowledgments None. output tended to be high volume the day before sclero- therapy (Table  3). Inflammatory change in an infected Authors’ contributions lymphocele render the lymphocele adhesive (Kim et  al., EK, YO and HH participated in article creation, response to revisions, and edit- ing. EK obtained images and generated tables. All authors read and approved 1999), so sclerotherapy for an infected lymphocele can the final manuscript. be performed in one session, but a non-infected lympho- cele can be required more sclerotherapy sessions than an Funding There are no funding disclosures related to this article. infected lymphocele. Also, OK-432 dilution due to high volume of drainage tube output may causes effective to Availability of data and materials weak. In this study, a major complication (small bowel All data gathered or analyzed in this study are included in this article. fistula) was observed in one patient. The patient had an infected lymphocele and was treated with sclerotherapy Declarations using OK-432, which resulted in a small bowel fistula. Ethics approval and consent to participate To the best of the authors’ knowledge, there have been This retrospective study was approved by the ethics committee of our hospi- no reports of scarring or dysfunction of the surround- tal. Formal consent is not required for this type of study. ing tissues due to OK-432, and the side effects were lim - Consent for publication ited to fever after injection. The small intestine wall was Not applicable. likely fragile due to the infection, and the administration Competing interests of OK-432 likely caused the fistula. Immediately before The authors declare that they have no competing interests. administering OK-432, the location of adjacent organs in the lymphocele may have changed from that before Received: 2 August 2022 Accepted: 14 October 2022 percutaneous drainage, and attention should be given to that immediately before administering OK-432. There is no significant correlation between the initial lymphocele References size and drainage duration after sclerotherapy (p = 0.113). Addo E, Kong MJ, El-Haddad G (2018) Embolization-sclerotherapy of a refrac- This result is supported by a report by Alago et al. (Alago tory large volume post-operative pelvic lymphocele. Urol Case Rep et  al., 2013). Although OK-432 is more expensive than 20:43–44. https:// doi. org/ 10. 1016/j. eucr. 2018. 06. 010 Akhan O, Karcaaltincaba M, Ozmen MN, Akinci D, Karcaaltincaba D, Ayhan A ethanol and povidone-iodine, OK-432 sclerotherapy (2007) Percutaneous transcatheter ethanol sclerotherapy and catheter facilitates early discharge owing to a shorter drainage drainage of postoperative pelvic lymphoceles. Cardiovasc Intervent period, which may reduce the overall hospital costs. Radiol 30(2):237–240. https:// doi. org/ 10. 1007/ s00270- 006- 0180-y Alago W, Deodhar A, Michell H, Sofocleous CT, Covey AM, Solomon SB, Getra- This study has some limitations. First, this study had jdman GI, Dalbagni G, Brown KT (2013) Management of postoperative a small sample size and was a retrospective study con- lymphoceles after lymphadenectomy: percutaneous catheter drainage ducted at a single institution. Further investigation, with and without povidone-iodine sclerotherapy. Cardiovasc Intervent Radiol 36(2):466–471. https:// doi. org/ 10. 1007/ s00270- 012- 0375-3 including treatment results in a large prospective study Baek Y, Won JH, Chang SJ, Ryu HS, Song SY, Yim B, Kim J (2016) Lymphatic and comparison of results with other sclerosing agents, embolization for the treatment of pelvic lymphoceles: preliminary experi- is required. Second, the procedure was not standard- ence in five patients. J Vasc Interv Radiol 27(8):1170–1176. https:// doi. org/ 10. 1016/j. jvir. 2016. 04. 011 ized owing to variability in the technique according to Chin A, Ragavendra N, Hilborne L, Gritsch HA (2007) Fibrin sealant sclero- individual operator preference. However, the drainage therapy for treatment of lymphoceles following renal transplantation. period of the OK-432 sclerotherapy was shorter than that J Urol 170(2 Pt 1):380–383. https:// doi. org/ 10. 1097/ 01. ju. 00000 74940. 12565. 80 of ethanol or povidone-iodine sclerotherapy. 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Percutaneous sclerotherapy with OK-432 for lymphocele after pelvic or para-aortic lymphadenectomy: preliminary results

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Abstract

Background: Lymphoceles can result from disruption of lymphatic vessels after surgical procedures in areas with extensive lymphatic networks. Percutaneous catheter drainage with sclerotherapy can be performed for the treat- ment of lymphoceles. OK-432 has been used to treat benign cysts, such as lymphangioma and ranula. Therefore, we aimed to report the efficacy and safety of sclerotherapy using OK-432 for postoperative lymphoceles. This study retro - spectively analyzed 16 patients who underwent sclerotherapy using OK-432 for postoperative pelvic and para-aortic lymphoceles between April 1, 2012, and March 31, 2020. All the patients underwent percutaneous drainage before sclerotherapy. The indications for sclerotherapy were persistent drainage tube output of greater than 50 mL per day and recurrent lymphoceles after percutaneous drainage. If less than 20 mL per day was drained after sclerotherapy, the tube was removed. When the drainage tube output did not decrease to less than 20 mL per day after the first sclerotherapy, the second sclerotherapy was performed 1 week later. Technical success was defined as the completion of drainage and sclerotherapy procedures. Clinical success was defined as the resolution of the patient’s symptoms resulting from lymphoceles without surgical intervention. This study also evaluated the complications of sclerother- apy and their progress after sclerotherapy. Results: The mean initial lymphocele size and drainage duration after sclerotherapy were 616 mL and 7.1 days, respectively. The technical success rate and clinical success rate were 100% and 93%, respectively. Thirteen patients were treated by one-session sclerotherapy and three patients were treated by two-session sclerotherapy. Minor com- plications (fever) were observed in eight patients (50%). A major complication (small bowel fistula) was observed in one patient (7%). No recurrence of lymphoceles was observed during the mean follow-up period of 17 months. Conclusion: Sclerotherapy with OK-432 is an effective therapeutic method for postoperative lymphoceles. Although most complications are minor, a small bowel fistula was observed in one patient. Keywords: OK-432, Sclerotherapy, Lymphocele vessels after surgical procedures in areas with extensive Background lymphatic networks. Lymphoceles can cause hydro- Lymphoceles are postoperative cystic collections of nephrosis, infection, abdominal pain, leg edema, and lymph fluid surrounded by a fibrous wall lacking epi - deep venous thrombosis (Karcaaltincaba & Akhan, thelium. They can result from disruption of lymphatic 2005a; vanSonnenberg et  al., 1986). The incidence rate of symptomatic lymphoceles ranges from 2% to 9%, *Correspondence: y-ono@radiol.med.osaka-u.ac.jp depending on the type of surgery (Goßler et  al., 2021; Department of Diagnostic and Interventional Radiology, Osaka University Heers et  al., 2015; Zikan et  al., 2015). Asymptomatic Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, Japan lymphoceles resolve spontaneously without treatment © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http:// creat iveco mmons. org/ licen ses/ by/4. 0/. Kashiwagi et al. CVIR Endovascular (2022) 5:55 Page 2 of 7 (Dodd et  al., 1970); however, symptomatic lympho- Material and Methods celes might require treatment. Treatment options for Patients symptomatic lymphoceles include percutaneous fine- This study was approved by the Institutional Review needle aspiration, percutaneous catheter drainage, Board of Osaka University Hospital, Japan. We percutaneous catheter drainage with sclerotherapy, reviewed the electronic medical records of all patients lymphatic embolization, and surgery (Ten Hove et  al., who underwent percutaneous drainage of postopera- 2021). Minimally invasive treatment has become the tive pelvic and para-aortic lymphoceles between April first treatment option (Ten Hove et  al., 2021). Percu - 1, 2012, and March 31, 2020, at our institution. A total taneous fine-needle aspiration is no longer performed of 50 lymphoceles in 45 patients (5 male, 40 female) due to its high recurrence rate, the need for frequent were treated by percutaneous drainage. There were 45 punctures, and infection risk (Jensen et  al., 1986; Kar- patients, 26 patients who were completely treated with caaltincaba & Akhan, 2005b). Lymphatic embolization percutaneous drainage alone and 3 patients who were has been reported as a treatment option because of its completely treated with sclerotherapy using minocy- high success and low recurrence rates. However, lym- cline alone were excluded from the study. Finally, 16 phatic embolization is often selected when the patient patients who underwent sclerotherapy with OK-432 does not respond to previous treatment (e.g., percuta- were included in this retrospective study. Sixteen neous catheter drainage with or without sclerotherapy), patients were diagnosed with 16 lymphoceles. Fifteen and this procedure requires a learning curve (Ten Hove patients underwent surgery for gynecological cancer, et  al., 2021; Addo et al., 2018; Baek et al., 2016). In the and one patient underwent surgery for rectal cancer. past, external drainage and internal marsupialization Patient characteristics are shown in Table  1. The diag - via laparotomy or laparoscopy were the treatment of nosis of lymphocele was based on clinical course and choice. However, surgery has a relatively high risk of imaging findings. Lymphocele infection was confirmed complications (e.g., injury to the bladder, ureter, and by fever, elevated white blood cell count and C-reactive ileus) and long hospitalization (Ten Hove et  al., 2021; protein level, or bacterial culture of the drainage fluid. Gill et  al., 1995). Currently, percutaneous catheter None of the patients had previously received surgi- drainage with or without sclerotherapy is often chosen cal treatment for lymphoceles, but one patient was for symptomatic lymphoceles and has achieved a high treated with OK-432 after failing to respond to sclero- success rate (Ten Hove et  al., 2021). Various agents therapy with ethanol, povidone-iodine, fibrin glue, and have been used for sclerotherapy, including povidone- minocycline. iodine, ethanol, tetracycline, bleomycin, and fibrin glue (Alago et al., 2013; Akhan et al., 2007; Chin et al., 2007; Filippiadis et  al., 2017). However, a consensus regard- Table 1 Characteristics of the patients ing effective sclerosing agents for lymphoceles has not Total cases (n = 16) yet been reached. OK-432 (Picibanil , Chugai Pharma- ceutical Co., Ltd., Tokyo, Japan) is a lyophilized mixture Mean age, years 56 (34-71) of a low-pathogenic strain of Streptococcus pyogenes Sex (Su) incubated with benzylpenicillin. It is widely used Male 0 to treat malignant pleural effusions, chylothorax, and Female 16 pneumothorax (Kasahara et  al., 2006; Ono et  al., 2010; Cancer types Takeda et  al., 2006). OK-432 sclerotherapy has been Gynecological cancer 15 reported to be effective in the treatment of benign Rectal cancer 1 cysts, such as lymphangioma and ranula (Ogita et  al., Site of lesion 1994; Roh, 2006). The mechanism of action of OK-432 Pelvic 14 on benign cysts is to immediately induce inflammation, Para-aortic 2 causing inflammatory cells to invade the cyst and cause Primary symptoms the cyst to adhere (Fujino et  al., 2003). Although scle- Fever 4 rotherapy with OK-432 for postoperative lymphoceles Abdominal pain 5 in the inguinal or axillary region has been reported Hydronephrosis 6 (Uyulmaz et  al., 2020), there have been no reports of Lower extremity edema 1 sclerotherapy with OK- 432 for lymphoceles after pelvic Infection of lymphoceles 8 and para-aortic lymphadenectomy in English literature. Previous treatment 1 This study aimed to report the efficacy and safety of One patient was treated with ethanol, povidone-iodine, fibrin glue, and sclerotherapy of lymphoceles using OK-432. minocycline before sclerotherapy with OK-432 K ashiwagi et al. CVIR Endovascular (2022) 5:55 Page 3 of 7 Procedures patients were observed by clinical follow-up and abdomi- All the patients underwent percutaneous drainage before nal CT. Technical success was defined as the completion sclerotherapy. Two patients underwent repeat drain of drainage and sclerotherapy procedures resulting in placement due to recurrent lymphoceles after initial adequate decrease of the drainage tube output and tube drain removal. Percutaneous drainage was performed removal. Clinical success was defined as the resolution under ultrasound or computed tomography (CT) guid- of the patient’s symptoms resulting from lymphoceles ance by an experienced interventional radiologist. A 7- to without surgical intervention. The estimated lymphocele 8.5-French pigtail catheter (Dawson-Mueller Drainage volume was calculated by CT volumetry using a software Catheters, Cook Medical) was placed into the cavity. If Aquarius iNtuition Edition version 4.4.13 . Complica- there was residual fluid, the drainage tube was exchanged tions were evaluated according to the classification of as needed to ensure sufficient drainage. Fifteen patients the CIRSE classification system (Filippiadis et  al., 2017). underwent sclerotherapy because of persistent drain- u Th s, Major complications were defined as grade 2 to age tube output of greater than 50 mL/day or recurrent grade 6. Minor complications were defined as grade 1. lymphoceles after percutaneous drainage. One patient underwent initial percutaneous drainage and consecu- Statistical analysis tive sclerotherapy in one session, based on the operator’s Data analyses were performed with EZR (Saitama Medi- judgment. Klinische Einheit (KE) is used to express the cal Center, Jichi Medical University, Saitama, Japan), preparation dosage. One KE of OK-432 contains 0.1 mg of which is a graphical user interface for R (The R Foun - dried cocci. OK-432 solution was prepared by dissolving dation for Statistical Computing, Vienna, Austria). The one KE of OK-432 in 10 mL of half diluted contrast media results are presented as mean (standard deviation [SD]) (Urografin-60; Bayer, Leverkusen, Germany) with saline. for quantitative variables and frequency (percentage) for After emptying the cavity, a cavitogram was obtained qualitative variables. In the statistical analysis, Pearson’s to exclude leakage from the lymphoceles (Fig.  1). The correlation coefficient was used to assess the correlation OK-432 solution was injected into the cavity and left between the initial lymphocele size and drainage dura- there for 2 hours, after which catheter was allowed to tion after sclerotherapy. Statistical significance was con - drain. The volume of OK-432 used for sclerotherapy was sidered at p-value of < 0.05. determined based on estimated volume of the residual cavity by a cavitogram immediately before sclerotherapy. Results If the drainage tube drained less than 20 mL per day after The mean initial lymphocele size was 616 (range, sclerotherapy, the tube was removed. When the drain- 76–3295) mL. The mean drainage duration after scle- age tube output did not decrease to less than 20 mL per rotherapy was 7.1 (Karcaaltincaba & Akhan, 2005a; day on the sixth day after the first sclerotherapy, the sec - vanSonnenberg et al., 1986; Goßler et al., 2021; Heers ond OK-432 sclerotherapy were performed on the sev- et  al., 2015; Zikan et al., 2015; Dodd et al., 1970; Ten enth day. All procedures were performed under local Hove et  al., 2021; Jensen et  al., 1986; Karcaaltincaba anesthesia during hospitalization. After discharge, the & Akhan, 2005b; Addo et  al., 2018; Baek et  al., 2016; Fig. 1 a Contrast-enhanced computed tomography (CT ) after gynecological cancer surgery in a 60-year-old woman presenting with left low leg lymphedema. CT shows left pelvic lymphocele (white arrow). b Cavitogram shows no leakage of the lymphocele Kashiwagi et al. CVIR Endovascular (2022) 5:55 Page 4 of 7 Fig. 2 Correlations between initial lymphocele size and drainage duration Table 2 Results of percutaneous sclerotherapy Table 3 Cases of sclerotherapy Total cases (n = 16) Case Number of Volume of OK-432 Drainage Infection sessions output Mean initial lymphocele size, mL 616 (76–3295) (mL/24 h) Mean drainage duration after sclerotherapy, days 7.1 (1–20) 1 2 2KE+4KE 50 – Mean volume of OK-432, KE 1.9 (1–4) 2 2 2KE+2KE 360 – Number of sessions 3 1 2KE 100 – One 13 4 1 2KE 130 – Two 3 5 1 2KE 200 Yes Technical success, n (%) 16 (100%) 6 1 2KE 120 Yes Clinical success, n (%) 15 (93%) 7 1 2KE 100 Yes Complication 8 1 2KE – – Major 1 9 1 2KE 100 Yes Minor 8 10 1 1KE 280 – The Klinische Einheit (KE) is used to express the dosage of preparation; 1 KE of 11 1 1KE 30 Yes OK-432 contains 0.1 mg of dried cocci 12 1 1KE 25 Yes 13 1 2KE 70 Yes 14 1 1KE 100 Yes Gill et al., 1995; Alago et al., 2013; Akhan et al., 2007; 15 2 2KE+2KE 810 – Chin et  al., 2007; Filippiadis et  al., 2017; Sacks et  al., 16 1 2KE 60 Yes 2003; Kasahara et  al., 2006; Ono et  al., 2010; Takeda et  al., 2006) days. Pearson’s correlation coefficient Drainage tube output the day before the first sclerotherapy showed moderately negative correlation (r = − 0.414) The case was treated with OK-432 after failing to respond to sclerotherapy with other sclerosing agents between the initial lymphocele size and drainage The case underwent initial percutaneous drainage and consecutive duration after sclerotherapy, but the association was sclerotherapy in one session not statistically significant (p = 0.113) (Fig .  2). The The cases were treated for recurrent lymphoceles after percutaneous drainage mean injection volume of OK-432 was 1.9 KE. The technical success rate was 100% (16/16). The clini- cal success rate was 93% (15/16). One patient with (7%). One month after the sclerotherapy, the patient hydronephrosis did not improve. Three patients presented with fever. CT revealed an abscess in the were treated by two-session sclerotherapy (Table  2). pelvis. Percutaneous drainage was performed, and The patients’ lymphoceles were not infected and the a cavitogram showed a small bowel fistula (Fig.  3). drainage tube output tended to be high volume the Consequently, the small bowel fistula was resolved day before the first sclerotherapy (Table  3). Minor only by percutaneous drainage. No recurrence of complications (grade 1) were observed in eight lymphoceles was observed during the mean follow- patients (50%), who presented with fever. Major up period of 17 (range, 2.5–49.8) months. complication (grade 3) was observed in one patient K ashiwagi et al. CVIR Endovascular (2022) 5:55 Page 5 of 7 Fig. 3 a Contrast-enhanced computed tomography (CT ) after gynecological cancer surgery in a 69-year-old woman presenting with abdominal pain. CT shows pelvic lymphocele. b Cavitogram shows lymphocele reduction, sclerotherapy with OK-432 was performed. c One month after sclerotherapy, CT showed abscess in the pelvic (white arrow). d Cavitogram shows a small bowel fistula (white arrow) Discussion with ethanol or povidone-iodine reported previously A variety of sclerosing agents have been used for sclero- (Table  4). However, the mean drainage duration of therapy of lymphoceles in previous reports (Alago et  al., OK-432 sclerotherapy (7.1 days) was trend to be shorter 2013; Akhan et  al., 2007; Chin et  al., 2007; Filippiadis than that of ethanol and povidone-iodine sclerotherapy et  al., 2017). This study is the first reports of sclerother - (Table 4). Sclerotherapy with ethanol or povidone-iodine apy with OK- 432 for lymphoceles after pelvic and para- was performed in multiple sessions (Sawhney et al., 1996; aortic lymphadenectomy. In our cohort, the first patient Zuckerman & Yeager, 1997; Montalvo et al., 1996; Rivera initially underwent sclerotherapy using various agents et  al., 1996), whereas sclerotherapy with OK-432 in this without effect. Therefore, we tried sclerotherapy using study was often performed in one session (81%, 13/16), OK-432. This study achieved a 93% clinical success rate. which may have resulted in a shorter drainage period. This result is similar to the success rate of sclerotherapy Because OK-432 is a strong irritant, this study suggests Table 4 Studies of various sclerotherapies References Agent Number of Mean drainage duration after Success rate, % lymphoceles sclerotherapy, days Akhan et al. (Akhan et al., 2007) ethanol 50 11.8 91 Sawhney et al. (Sawhney et al., 1996) ethanol 14 36 93 Zuckerman and Yeager. (Zuckerman & ethanol 32 19 94 Yeager, 1997) Alago et al. (Alago et al., 2013) povidone-iodine 18 13 100 Montalvo et al. (Montalvo et al., 1996) povidone-iodine 17 36 82 Rivera et al. (Rivera et al., 1996) povidone-iodine 19 13 62.5 Our study OK-432 16 7.1 93 Kashiwagi et al. CVIR Endovascular (2022) 5:55 Page 6 of 7 Abbreviations that sclerotherapy with OK-432 can be completed in one CT: Computed tomography; KE: Klinische Einheit. session. Three patients who underwent two sessions of sclerotherapy were not infected and the drainage tube Acknowledgments None. output tended to be high volume the day before sclero- therapy (Table  3). Inflammatory change in an infected Authors’ contributions lymphocele render the lymphocele adhesive (Kim et  al., EK, YO and HH participated in article creation, response to revisions, and edit- ing. EK obtained images and generated tables. All authors read and approved 1999), so sclerotherapy for an infected lymphocele can the final manuscript. be performed in one session, but a non-infected lympho- cele can be required more sclerotherapy sessions than an Funding There are no funding disclosures related to this article. infected lymphocele. Also, OK-432 dilution due to high volume of drainage tube output may causes effective to Availability of data and materials weak. In this study, a major complication (small bowel All data gathered or analyzed in this study are included in this article. fistula) was observed in one patient. The patient had an infected lymphocele and was treated with sclerotherapy Declarations using OK-432, which resulted in a small bowel fistula. Ethics approval and consent to participate To the best of the authors’ knowledge, there have been This retrospective study was approved by the ethics committee of our hospi- no reports of scarring or dysfunction of the surround- tal. Formal consent is not required for this type of study. ing tissues due to OK-432, and the side effects were lim - Consent for publication ited to fever after injection. The small intestine wall was Not applicable. likely fragile due to the infection, and the administration Competing interests of OK-432 likely caused the fistula. Immediately before The authors declare that they have no competing interests. administering OK-432, the location of adjacent organs in the lymphocele may have changed from that before Received: 2 August 2022 Accepted: 14 October 2022 percutaneous drainage, and attention should be given to that immediately before administering OK-432. There is no significant correlation between the initial lymphocele References size and drainage duration after sclerotherapy (p = 0.113). Addo E, Kong MJ, El-Haddad G (2018) Embolization-sclerotherapy of a refrac- This result is supported by a report by Alago et al. (Alago tory large volume post-operative pelvic lymphocele. 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Journal

CVIR Endovascular – Springer Journals

Published: Oct 20, 2022

Keywords: OK-432; Sclerotherapy; Lymphocele

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