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EP Combined With RFA for Ampullary Neoplasms With Intraductal Biliary Extension

Primary Purpose

Ampullary Adenomas

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endoscopic Papillectomy
Endobiliary Radiofrequency Ablation
Sponsored by
First People's Hospital of Hangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ampullary Adenomas focused on measuring Endoscopic papillectomy, Radiofrequency ablation, Ampullary neoplasms, Intraductal biliary extension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hangzhou First People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EP combined with RFA

Arm Description

Endoscopic Papillectomy Combined with Endobiliary Radiofrequency Ablation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Complete resection of ampullary adenomas
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
Endoscopic success was defined as complete ablation of the lesion without residual neoplasia or recurrence at the 6-month follow-up endoscopy.
adverse events
adverse events such as bleeding, acute pancreatitis after procedure

Full Information

First Posted
August 25, 2021
Last Updated
November 21, 2021
Sponsor
First People's Hospital of Hangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT05028465
Brief Title
EP Combined With RFA for Ampullary Neoplasms With Intraductal Biliary Extension
Official Title
The Efficacy and Safety of Endoscopic Papillectomy Combined With Endobiliary Radiofrequency Ablation for Ampullary Neoplasms With Intraductal Biliary Extension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2013 (Actual)
Primary Completion Date
November 20, 2021 (Actual)
Study Completion Date
November 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First People's Hospital of Hangzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ampullary Adenomas
Keywords
Endoscopic papillectomy, Radiofrequency ablation, Ampullary neoplasms, Intraductal biliary extension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EP combined with RFA
Arm Type
Experimental
Arm Description
Endoscopic Papillectomy Combined with Endobiliary Radiofrequency Ablation
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Papillectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endobiliary Radiofrequency Ablation
Intervention Description
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 Outcome Measure Information:
Title
Recurrence
Description
Recurrence was defined as discovery of neoplasia after a negative surveillance endoscopy and biopsy
Time Frame
one year
Secondary Outcome Measure Information:
Title
Complete resection of ampullary adenomas
Description
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.
Time Frame
three months
Title
Endoscopic success
Description
Endoscopic success was defined as complete ablation of the lesion without residual neoplasia or recurrence at the 6-month follow-up endoscopy.
Time Frame
six months
Title
adverse events
Description
adverse events such as bleeding, acute pancreatitis after procedure
Time Frame
one months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianfeng Yang, Dr.
Organizational Affiliation
First People's Hospital of Hangzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28610856
Citation
Watson RR, Muthusamy VR. Radiofrequency ablation for intraductal extension of ampullary neoplasms: Are we ready to feel the burn? Gastrointest Endosc. 2017 Jul;86(1):177-179. doi: 10.1016/j.gie.2016.12.022. No abstract available.
Results Reference
background
PubMed Identifier
29660322
Citation
Camus M, Napoleon B, Vienne A, Le Rhun M, Leblanc S, Barret M, Chaussade S, Robin F, Kaddour N, Prat F. Efficacy and safety of endobiliary radiofrequency ablation for the eradication of residual neoplasia after endoscopic papillectomy: a multicenter prospective study. Gastrointest Endosc. 2018 Sep;88(3):511-518. doi: 10.1016/j.gie.2018.04.2332. Epub 2018 Apr 13.
Results Reference
background
PubMed Identifier
29342492
Citation
Yang J, Wang J, Zhou H, Zhou Y, Wang Y, Jin H, Lou Q, Zhang X. Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial. Endoscopy. 2018 Aug;50(8):751-760. doi: 10.1055/s-0043-124870. Epub 2018 Jan 17.
Results Reference
background

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EP Combined With RFA for Ampullary Neoplasms With Intraductal Biliary Extension

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