Overview

This trial is active, not recruiting.

Condition adenoma, bile duct
Treatment habib™ endohbp
Sponsor Hôpital Cochin
Start date November 2012
End date February 2017
Trial size 20 participants
Trial identifier NCT02825524, 2011-A00721-40

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
habib™ endohbp
During an endoscopic retrograde cholangiography, endobiliary application of radiofrequency through a dedicated probe named Habib.

Primary Outcomes

Measure
number of residual neoplasia
time frame: one year

Secondary Outcomes

Measure
presence of low grade dysplasia or high grade dysplasia or invasive carcinoma
time frame: 6 months
number of surgery
time frame: one year
fever
time frame: 48 hours post endoscopic procedure
pain
time frame: 48 hours post endoscopic procedure
bleeding
time frame: 48 hours post endoscopic procedure
acute pancreatitis
time frame: 48 hours post endoscopic procedure
cholangitis
time frame: 48 hours post endoscopic procedure
perforation
time frame: 48 hours post endoscopic procedure

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Hôpital Cochin.