This prospective, single-center, pilot study included consecutive patients aged 20 years or older who developed obstructive jaundice and/or cholangitis due to unresectable MDBO between February 2020 and January 2022. The exclusion criteria were as follows: difficulty in reaching the duodenal papilla, surgically altered gastrointestinal anatomy, short stricture length unsuitable for the RFA catheter used in the study7 (link), Eastern Cooperative Oncology Group performance status 4, severe dysfunction in any other organ, and refusal to participate in the study. Temporary predrainage was implemented with a plastic stent or nasobiliary drainage until the presence of a malignancy and unresectability, such as metastasis, locally advanced, and/or poor general condition were confirmed.
The institutional review board of Aichi Medical University Hospital approved this study, which was conducted in accordance with the principles of the Declaration of Helsinki (approval number: 2019-169). All patients provided written informed consent before the procedure and study participation. The study protocol was registered with the University Hospital Medical Information Network Clinical Trial Registry database (Identifier: UMIN000039563).
The institutional review board of Aichi Medical University Hospital approved this study, which was conducted in accordance with the principles of the Declaration of Helsinki (approval number: 2019-169). All patients provided written informed consent before the procedure and study participation. The study protocol was registered with the University Hospital Medical Information Network Clinical Trial Registry database (Identifier: UMIN000039563).
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