EP Combined With RFA for Ampullary Neoplasms With Intraductal Biliary Extension

Zhejiang University

Status: Completed

Conditions: Ampullary Adenomas

Treatments: Procedure: Endoscopic Papillectomy; Procedure: Endobiliary Radiofrequency Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05028465

2021-08-118

Details and patient eligibility

About

Endoscopic papillectomy is the preferred approach for management of ampullary adenomas. Endobiliary radiofrequency ablation (RFA) is an ablative therapy that has been used to treat malignant biliary strictures. The aim of this study was to evaluate the safety and efficacy of endoscopic papillectomy combined with endobiliary RFA for ampullary neoplasms with intraductal biliary extension.

Full description

Ampullary neoplasms remain rare, with a reported prevalence of 0.04% to 0.12% in autopsy studies. , endoscopic papillectomy is now recognized as a safe and reliable alternative to surgery for ampullary adenomas and is associated with high success rates (72%-95%), low morbidity (10%-30%), and minimal mortality (0.2%-1%). Typically, however, intrabiliary extension of the adenoma has been regarded as a contraindication for endoscopic papillectomy. Surgical referral is therefore recommended with intraductal extension, particularly when the length of extension exceeds 1 cm. Radiofrequency ablation offers a potentially safe and effective treatment for malignant biliary strictures. The use of RFA as a primary treatment for intraductal dysplasia after endoscopic papillectomy has been shown in few small case series to be feasible with the primary limitation of short follow-up periods. The primary aim of this study was to describe our experience with RFA in patients with ampullary neoplasia and associated intraductal extension who were not surgical candidates.

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically proven ampullary adenoma or adenocarcinoma with intraductal biliary extension ≥1cm who were deemed medically unfit for surgery or declined surgery

Exclusion criteria

• pancreatic invasion, lymph node invasion, distant metastasis, or coagulopathy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

EP combined with RFA

Experimental group

Description:

Endoscopic Papillectomy Combined with Endobiliary Radiofrequency Ablation

Treatment:

Procedure: Endobiliary Radiofrequency Ablation

Procedure: Endoscopic Papillectomy