Assessment of Cholangio-pancreatoscopy for the Diagnosis... | NCT03190343

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016Actual

Primary Completion Date

Jan 28, 2019Actual

Completion Date

Jan 2020Estimated

First Submitted Date

Jun 14, 2017

First Submission Date that Met QC Criteria

Jun 14, 2017

First Posted Date

Jun 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2019

Last Update Posted Date

Apr 4, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arthur Laquiere, Gastroenterologist, Hospital St. Joseph, Marseille, FrancePrincipal Investigator

Lead Sponsor

Hospital St. Joseph, Marseille, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 However this technology with optic fiber quickly had proved outdated for several reasons: poor manoeuvrability, perfectible optical vision, optical fibers fragility and cost.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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Name	Type	Description	Arm Group Labels	Other Names
cholangio-pancreatoscopy	Procedure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

PATIENTS WITH BILIARY OR PANCREATIC DUCT STENOSIS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ARTHUR LAQUIERE, MD	French Society of Digestive Endoscopy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Mermoz		Lyon		69008	France
Hopital Saint Joseph

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8857851	Result	Nakeeb A, Pitt HA, Sohn TA, Coleman J, Abrams RA, Piantadosi S, Hruban RH, Lillemoe KD, Yeo CJ, Cameron JL. Cholangiocarcinoma. A spectrum of intrahepatic, perihilar, and distal tumors. Ann Surg. 1996 Oct;224(4):463-73; discussion 473-5. doi: 10.1097/00000658-199610000-00005.
3557026	Result	Bar-Meir S, Rotmensch S. A comparison between peroral choledochoscopy and endoscopic retrograde cholangiopancreatography. Gastrointest Endosc. 1987 Feb;33(1):13-4. doi: 10.1016/s0016-5107(87)71476-x.

ID	Term
D001660	Biliary Tract Diseases
D003137	Common Bile Duct Diseases

ID	Term
D004066	Digestive System Diseases
D001649	Bile Duct Diseases