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EP Combined With RFA for Ampullary Neoplasms With Intraductal Biliary Extension

NCT05028465 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-11-23

No results posted yet for this study

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.

Conditions

  • Ampullary Adenomas

Interventions

PROCEDURE

Endoscopic Papillectomy

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.

PROCEDURE

Endobiliary Radiofrequency Ablation

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.

Sponsors & Collaborators

  • First People's Hospital of Hangzhou

    lead OTHER

Principal Investigators

  • Jianfeng Yang, Dr. · First People's Hospital of Hangzhou

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-10
Primary Completion
2021-11-20
Completion
2021-11-21

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05028465 on ClinicalTrials.gov