Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases

• Conditions: Common Bile Duct Diseases; Lesions of Biliary or Wirsung Ducts; Biliary Tract Diseases; Pancreatic Duct Disorder

• Registration Number: NCT03190343
• Lead Sponsor: Hospital St. Joseph, Marseille, France

Brief Summary

The biliary and pancreatic tumors are rare but the prognosis is pejorative. It was difficult to have histology of these tumors as the samples taken during ERCP were performed under " blind " radiology control. So the diagnostic accuracy was insufficient.

The arrival of A new optic fiber endoscope used by only one operator had improved the diagnostic of bilio-pancreatic diseases. However this technology with optic fiber quickly had proved outdated for several reasons: poor manoeuvrability, perfectible optical vision, optical fibers fragility and cost.

A new generation of endoscopes with digital vision appeared and would allow an increase in diagnostic accuracy related to better vision and manoeuvrability.

The purpose of the study is to assess the interest of the cholangio pancreatoscopy performed with digital vision.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-16
• Primary Completion: 2019-01-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-04
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Patients aged ≥ 18 years
• Patients with biliary duct stenosis with undetermined etiology
• Patients with pancreatic duct stenosis with undetermined etiology
• Patients with pancreatic duct distension with undetermined etiology
• Patients with biliary or pancreatic gallstones after failure to endoscopic treatment

Exclusion Criteria

• Patients with haemorrhagic disease or hemostasis and coagulation disorders (TP < 60%, TCA> 40 sec. and platelets < 60000/mm3).
• Patients treated with anticoagulant or platelet aggregation inhibiting drugs that could not be temporarily interrupted.
• Patients with biliary duct diameter < 3 mm
• Patients with pancreatic duct diameter <3 mm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the diagnostic accuracy of the Spyglass to distinguish a benign lesion from a malignant lesion of the biliary or Wirsung ducts.	4 YEARS

Trial Locations

Locations (3)

Centre Hospitalier Jacques Lacarin; 🇫🇷 Vichy, France

Hopital Saint Joseph; 🇫🇷 Marseille, France

Hopital Mermoz; 🇫🇷 Lyon, France