Destruction of Residual Endo-biliary Dysplastic Buds After Endoscopic Ampullectomy (endoHPB)

Efficacy and Safety of Endobiliairy Radiofrequency (Probe Habib TM EndoHPB) for the Destruction of Residual Endo Biliairy Dysplastic Buds After Endoscopic Ampullectomy: Prospective Multicenter Study

The purpose of the study is to assess the efficacy and morbidity of biliairy radiofrequency ablation for the treatment of dysplastic endobiliairy residual lesions (low-grade dysplasia or high-grade dysplasia) after endoscopic ampullectomy for ampullary adenoma.

Study Overview

• Status: Completed
• Conditions: Adenoma, Bile Duct
• Intervention / Treatment: Device: Habib™ EndoHBP

Detailed Description

Neoplastic lesions may persist at the termination of the common bile duct or pancreatic duct, after endoscopic ampullectomy for adenoma. Such lesions conduct to a difficult therapeutic problem because surgery (pancreaticoduodenectomy or trans-duodenal resection) has significant morbidity compared to non-invasive lesions. The use of endoscopic destruction techniques of dysplastic lesions, including radio-frequency could be an interesting alternative to reduce the risk of invasive cancer with less morbidity. Ablation with radio-frequency (RF) is a technique of local tissue destruction in use in many applications, percutaneously or intraoperatively for the treatment of hepatocellular carcinoma smaller and more recently for the endoscopic treatment of high-grade dysplasia of Barrett's esophagus. An RF probe has been developed for an endo-biliary application (Habib EndoHPB, Emcision) and 2 preliminary studies have reported the use in humans, in the indication of unresectable cholangiocarcinoma. These two studies have confirmed the feasibility of the technique, with few side effects and probable anti-tumor efficacy demonstrated by expanding the area of stenosis after treatment.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of lesions of low-grade dysplasia (LGD) or high grade (HGD) in the common bile duct, confirmed by two pathological readings in relation to residual adenomatous tissue into the common bile duct after endoscopic ampullectomy for ampullome conducted in the previous year
• Lack of residual adenomatous lesion on the duodenal side after ampullectomy and possibly additional procedures (endoscopic mucosal resection or argon plasma). (excluding other duodenal adenomatous lesions in the context of familial adenomatous polyposis
• Consultative multidisciplinary digestive cancer meeting confirming the indication of treatment with endo-biliary radio-frequency
• Dysplastic lesions extending over 20 mm length maximum in the common bile duct
• Patients aged ≥ 18 years old and ≤ 85 years old
• Patients who consented to participate in the study
• No anesthesia contraindication (ASA 1,2,3)
• Patient affiliated to a social security scheme (beneficiary or legal)
• Lack of pregnancy and contraception being women age procreate

Exclusion Criteria:

• Lesions of invasive carcinoma in a patient whose clinical condition allows to consider a pancreaticoduodenectomy
• Endo-biliary dysplastic lesions diffuse or multifocal
• Presence of non extractable metal biliary expansive prosthesis
• History of pancreaticoduodenectomy or hepaticojejunostomy anastomosis
• Impassable stenosis of the common bile duct
• Severe coagulopathy, thrombocytopenia < 75,000 G/L , Clopidogrel treatment impossible to stop temporarily
• Anesthesia contraindication ( ASA 4)
• Pace maker or other active implantable medical device
• Inability to obtain informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endobiliary radiofrequency	Device: Habib™ EndoHBP; During an endoscopic retrograde cholangiography, endobiliary application of radiofrequency through a dedicated probe named Habib.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of residual neoplasia	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
presence of low grade dysplasia or high grade dysplasia or invasive carcinoma		6 months
number of surgery		one year
fever		48 hours post endoscopic procedure
pain	Visual Analogue Scale	48 hours post endoscopic procedure
bleeding	hematemesis, hematochezia or melena or decreased more than 2 points of hemoglobin	48 hours post endoscopic procedure
acute pancreatitis	pain and increased of lipase more than 3 fold	48 hours post endoscopic procedure
cholangitis	fever and abnormal hepatic blood tests	48 hours post endoscopic procedure
perforation	pneumoperitoneum, retropneumoperitoneum, pneumothorax	48 hours post endoscopic procedure

Collaborators and Investigators

• Sponsor: Hôpital Cochin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: July 4, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma; Adenoma, Bile Duct
• Other Study ID Numbers: 2011-A00721-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No