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The use of a 532-nm laser fitted with a balloon and a cylindrical light diffuser to treat benign biliary stricture: a pilot study

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Abstract

Endoscopic management of benign biliary stricture (BBS) remains challenging. Stenting is currently used for BBS management, but refractory BBS remains problematic. The aim of this study was to assess the safety and feasibility of a dilation balloon-equipped cylindrical light diffuser for BBS in a large animal model. A total of seven mini-pigs were used in the current study. Laser settings were chosen based on the findings of a previous animal study. Five animals were used in a preliminary study to establish process conditions. BBSs were created in the common bile ducts of the other two animals by intraductal radiofrequency ablation (RFA) via endoscopic retrograde cholangiography (ERC). At 4 weeks post-RFA, laser ablation was performed using a customized balloon-equipped cylindrical diffuser at 10 W for 10 s while maintaining balloon inflation for 10 s at 5 atm. A follow-up ERC was performed at 4 weeks post-laser ablation and the animals were sacrificed for histologic evaluation. BBS was observed in all animals by ERC at 4 weeks post-RFA. The mean bile duct stricture diameter in the two animals as determined by ERC was 0.8 mm. Laser ablations were performed without technical difficulty and no adverse event was encountered. At 4 weeks post-laser ablation, mean biliary stricture diameter had dilated to 1.6 mm on cholangiographic finding. On histologic examination, inflammatory cell infiltration in lamina propria and dense collagen deposition were observed, but there was no evidence of bile duct perforation. The devised balloon-equipped cylindrical laser light diffuser appears to be safe and feasible for the treatment of BBS. However, further studies and modifications are required before it can be applied clinically as a monotherapy.

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Funding

This research was supported by the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI) funded by the Ministry of Health and Welfare, Republic of Korea (Grant number: HI16C1017).

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Authors and Affiliations

  1. Department of Internal Medicine, Inha University School of Medicine, Incheon, South Korea

    Jin-Seok Park, Seok Jeong & Don Haeng Lee

  2. National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders (NCEED), Incheon, South Korea

    Jin-Seok Park, Seok Jeong & Don Haeng Lee

  3. Division of Gastroenterology, Department of Internal Medicine, Inha University School of Medicine, Inha University Hospital, 27 Inhang-ro, Jung-gu, Incheon, 400-711, South Korea

    Seok Jeong & Don Haeng Lee

  4. Department of Pathology, Inha University School of Medicine, Incheon, South Korea

    Joon Mee Kim

  5. Bluecore Company, Busan, South Korea

    Sung Min Kim & Hyun Wook Kang

  6. Department of Biomedical Engineering and Center for Marine-Integrated Biomedical Technology (BK21 Plus), Pukyong National University, Busan, South Korea

    Hyun Wook Kang

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  1. Jin-Seok Park
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  2. Seok Jeong
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Correspondence to Seok Jeong or Don Haeng Lee.

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The Animal Care and Use Committee of our institution reviewed and approved the study design beforehand (18-KE-283).

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Park, JS., Jeong, S., Lee, D.H. et al. The use of a 532-nm laser fitted with a balloon and a cylindrical light diffuser to treat benign biliary stricture: a pilot study. Lasers Med Sci 36, 25–31 (2021). https://doi.org/10.1007/s10103-020-02992-6

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  • DOI: https://doi.org/10.1007/s10103-020-02992-6

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