EP Combined With RFA for Ampullary Neoplasms With Intraductal Biliary Extension

Not Applicable

Completed

• Conditions: Ampullary Adenomas
• Interventions: Procedure: Endoscopic Papillectomy; Procedure: Endobiliary Radiofrequency Ablation

• Registration Number: NCT05028465
• Lead Sponsor: First People's Hospital of Hangzhou

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-02-10
• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-08-31
• Status Verified: 2021-11
• Primary Completion: 2021-11-20
• Study Completion: 2021-11-21
• Last Update Submitted: 2021-11-21
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EP combined with RFA	Endoscopic Papillectomy	Endoscopic Papillectomy Combined with Endobiliary Radiofrequency Ablation
EP combined with RFA	Endobiliary Radiofrequency Ablation	Endoscopic Papillectomy Combined with Endobiliary Radiofrequency Ablation

Primary Outcome Measures

Name	Time	Method
Recurrence	one year	Recurrence was defined as discovery of neoplasia after a negative surveillance endoscopy and biopsy

Secondary Outcome Measures

Name	Time	Method
Complete resection of ampullary adenomas	three months	Complete resection of ampullary adenomas was confirmed when no residual tissue was found on ampullary and intraductal biopsies at the 3-month follow-up ERCP.
Endoscopic success	six months	Endoscopic success was defined as complete ablation of the lesion without residual neoplasia or recurrence at the 6-month follow-up endoscopy.
adverse events	one months	adverse events such as bleeding, acute pancreatitis after procedure

Trial Locations

Locations (1)

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China