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

Primary Purpose

Adenoma, Bile Duct

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Habib™ EndoHBP

About this trial

This is an interventional treatment trial for Adenoma, Bile Duct

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endobiliary radiofrequency

Arm Description

Outcomes

Primary Outcome Measures

number of residual neoplasia

Secondary Outcome Measures

presence of low grade dysplasia or high grade dysplasia or invasive carcinoma

number of surgery

fever

pain

Visual Analogue Scale

bleeding

hematemesis, hematochezia or melena or decreased more than 2 points of hemoglobin

acute pancreatitis

pain and increased of lipase more than 3 fold

cholangitis

fever and abnormal hepatic blood tests

perforation

pneumoperitoneum, retropneumoperitoneum, pneumothorax

Full Information

NCT ID

NCT02825524

First Posted

June 15, 2016

Last Updated

August 25, 2017

Sponsor

Hôpital Cochin

1. Study Identification

Unique Protocol Identification Number

NCT02825524

Brief Title

Destruction of Residual Endo-biliary Dysplastic Buds After Endoscopic Ampullectomy

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hôpital Cochin

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenoma, Bile Duct

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endobiliary radiofrequency

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Habib™ EndoHBP

Intervention Description

During an endoscopic retrograde cholangiography, endobiliary application of radiofrequency through a dedicated probe named Habib.

Primary Outcome Measure Information:

Title

number of residual neoplasia

Time Frame

one year

Secondary Outcome Measure Information:

Title

presence of low grade dysplasia or high grade dysplasia or invasive carcinoma

Time Frame

6 months

Title

number of surgery

Time Frame

one year

Title

fever

Time Frame