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OpenTrials
Completed

NCT Number: NCT05028465

EP Combined With RFA for Ampullary Neoplasms With Intraductal Biliary Extension

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.

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Key information

Conditions

Ampullary Adenomas

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic Papillectomy

Procedure

A snare devicewas inserted via the working channel, and the endoscopist adjusted the snare to securely grasp the lesion, which was then excised by using standard electrocautery.

Endobiliary Radiofrequency Ablation

Procedure

The RFA catheter was then placed under fluoroscopic guidance across the distal common bile duct. An ERBE VIO200D generator (ERBE Elktromedizin, Tubingen, Germany) was connected for RFA at 10 W for 90 seconds.

Primary outcomes

  1. Recurrence

    Time frame: one year

    Recurrence was defined as discovery of neoplasia after a negative surveillance endoscopy and biopsy

Secondary outcomes

  1. Complete resection of ampullary adenomas

    Time frame: 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.

  2. Endoscopic success

    Time frame: six months

    Endoscopic success was defined as complete ablation of the lesion without residual neoplasia or recurrence at the 6-month follow-up endoscopy.

  3. adverse events

    Time frame: one months

    adverse events such as bleeding, acute pancreatitis after procedure

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

The Efficacy and Safety of Endoscopic Papillectomy Combined With Endobiliary Radiofrequency Ablation for Ampullary Neoplasms With Intraductal Biliary Extension

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2021
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.