Destruction of Residual Endo-biliary Dysplastic Buds After Endoscopic Ampullectomy

Adenoma, Bile Duct Clinical Trial

— endoHPB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825524
• Other study ID #: 2011-A00721-40
• Status: Completed
• Phase: N/A
• First received: June 15, 2016
• Last updated: August 25, 2017
• Start date: November 2012
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: Hôpital Cochin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma, Bile Duct

Intervention

Device:
• Habib™ EndoHBP
During an endoscopic retrograde cholangiography, endobiliary application of radiofrequency through a dedicated probe named Habib.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Cochin

Outcome

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