NCT05028465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2013

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2021

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

8.8 years

First QC Date

August 25, 2021

Last Update Submit

November 21, 2021

Conditions

Ampullary Adenomas

Keywords

Endoscopic papillectomyRadiofrequency ablationAmpullary neoplasmsIntraductal biliary extension

Outcome Measures

Primary Outcomes (1)

  • Recurrence

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

    one year

Secondary Outcomes (3)

  • Complete resection of ampullary adenomas

    three months

  • Endoscopic success

    six months

  • adverse events

    one months

Study Arms (1)

EP combined with RFA

EXPERIMENTAL

Endoscopic Papillectomy Combined with Endobiliary Radiofrequency Ablation

Procedure: Endoscopic PapillectomyProcedure: Endobiliary Radiofrequency Ablation

Interventions

Endoscopic PapillectomyPROCEDURE

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.

EP combined with RFA
Endobiliary Radiofrequency AblationPROCEDURE

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.

EP combined with RFA

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically proven ampullary adenoma or adenocarcinoma with intraductal biliary extension ≥1cm who were deemed medically unfit for surgery or declined surgery

You may not qualify if:

  • pancreatic invasion, lymph node invasion, distant metastasis, or coagulopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

Location

Related Publications (3)

  • 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.

    PMID: 28610856BACKGROUND

  • 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.

    PMID: 29660322BACKGROUND

  • 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.

    PMID: 29342492BACKGROUND

Study Officials

  • Jianfeng Yang, Dr.

    First People's Hospital of Hangzhou

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 25, 2021

First Posted

August 31, 2021

Study Start

February 10, 2013

Primary Completion

November 20, 2021

Study Completion

November 21, 2021

Last Updated

November 23, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)