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EP Combined With RFA for Ampullary Neoplasms With Intraductal Biliary Extension

NCT ID: NCT05028465

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-10

Study Completion Date

2021-11-21

Brief Summary

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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

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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.

Conditions

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Ampullary Adenomas

Keywords

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Endoscopic papillectomy Radiofrequency ablation Ampullary neoplasms Intraductal biliary extension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EP combined with RFA

Endoscopic Papillectomy Combined with Endobiliary Radiofrequency Ablation

Group Type EXPERIMENTAL

Endoscopic Papillectomy

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First People's Hospital of Hangzhou

OTHER

Sponsor Role lead

Responsible Party

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Jianfeng Yang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianfeng Yang, Dr.

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Hangzhou

Locations

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Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 28610856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29660322 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29342492 (View on PubMed)

Other Identifiers

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2021-08-118

Identifier Type: -

Identifier Source: org_study_id