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

Hôpital Cochin

Status

Completed

Conditions

Adenoma, Bile Duct

Treatments

Device: Habib™ EndoHBP

Study type

Interventional

Funder types

Other

Identifiers

NCT02825524

2011-A00721-40

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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