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Lymphatic Embolization versus Sclerotherapy for Symptomatic Post-operative Pelvic Lymphocele (LESPOL): A Randomized Pilot Study

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Abstract

This study was performed to compare clinical outcomes of lymphatic n-butyl cyanoacrylate (NBCA) embolization and ethanol sclerotherapy in patients with symptomatic postoperative pelvic lymphoceles. This prospective, open-label, randomized, and controlled trial took place at two medical centers in Korea. Patients ≥ 18 years old with symptomatic postoperative pelvic lymphoceles were randomly assigned (1:1) to one of two study arms: embolization or sclerotherapy. A target of 44 patients was set for each group to assess clinical outcomes. The trial began in August 2018 but ended as a pilot study in February 2020. Problematic patient enrollment precluded full population recruitment, only 11 patients (embolization, 5; sclerotherapy, 6) eventually participating. Clinical success and drainage tube removal rates were 100% in both arms. To achieve clinical success, significantly more procedures were needed in the sclerotherapy group than in the embolization group (4.5 ± 1.23 vs 2.0 ± 1.00; p < 0.001). The time to achieve daily drainage reduction thresholds (< 20 mL or < 20% of initial daily drainage) was also less in the sclerotherapy (vs embolization) group but fell short of statistical significance (4.8 ± 2.63 days vs 7.0 ± 3.67 days; p = 0.267). No significant adverse events or recurring symptomatic lymphoceles were evident at 3-month follow-up visits. Both NBCA embolization and ethanol sclerotherapy might be safe and effective in treating symptomatic postoperative pelvic lymphoceles, showing no significant difference in clinical outcomes. In a future randomized prospective study, it is essential to establish better inclusion criteria to selectively include intractable lymphoceles to find out the difference in the outcome between the two treatments.

Trial registration: The study is registered as KCT0003078 at the Clinical Research Information Service (http://cris.nih.go.kr). Registered April 2, 2018.

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Data Availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Code Availability

Not applicable.

Abbreviations

PCD :

Percutaneous catheter drainage

NBCA :

N-Butyl Cyanoacrylate

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Acknowledgements

The authors are grateful for the statistical expertise provided by the Medical Research Collaborating Center at Seoul National University Hospital.

Funding

This study was funded by a grant from the Guerbet Korea Research Fund.

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Authors and Affiliations

Authors

Contributions

In Joon Lee: Project management, data collection and analysis, manuscript writing and editing.

Jinoo Kim: Project development and management, data analysis, manuscript editing.

Gyoung Min Kim: Project management, manuscript editing.

Ji Hoon Shin: Project management, manuscript editing.

Hee Seung Kim: Data collection, manuscript editing.

Cheol Kwak: Data collection, manuscript editing.

Ho Kyung Seo: Data collection, manuscript editing.

Myong Cheol Lim: Data collection, manuscript editing.

Saebeom Hur: Project development and management, data collection and analysis, manuscript writing and editing.

Corresponding author

Correspondence to Saebeom Hur.

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Ethics Approval and Consent to Participate

The study protocol was approved by the Institutional Review Board of Seoul National University Hospital (No. 1802–100-924) and the National Cancer Center (No. NCC2018-0144). All patients granted written informed consent and all data were de-identified after collection.

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Informed consent was obtained from all patients.

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Not applicable.

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None of the authors has any conflicts to disclose.

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Lee, I.J., Kim, J., Kim, G.M. et al. Lymphatic Embolization versus Sclerotherapy for Symptomatic Post-operative Pelvic Lymphocele (LESPOL): A Randomized Pilot Study. SN Compr. Clin. Med. 5, 96 (2023). https://doi.org/10.1007/s42399-023-01432-0

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