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Cholangioscopy or Conventional Techniques for Indeterminate Biliary Stenosis

Primary Purpose

Malignant Biliary Stenosis

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP

About this trial

This is an interventional diagnostic trial for Malignant Biliary Stenosis focused on measuring biliary stenosis, cholangioscopy, cholangiocarcinoma, ERCP

Eligibility Criteria

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

Inclusion Criteria:

Presence of intra- or extrahepatic biliary stenosis, involving the main bile ducts: common hepatic duct, right and left hepatic ducts
Presence of clinical jaundice and / or biological cholestasis (GGT> 3N)
Absence of visible mass near the biliary stenosis after initial morphological assessment by abdominal CT scan, MRI with biliary sequences.
Endoscopic ultrasound performed and not having allowed the acquisition of material of diagnostic interest by guided puncture of the lesion.
No history of ERCP in the 6 months preceding inclusion and no biliary prosthesis (plastic or metal) in place at the time of inclusion
Collegial validation of the need for a formal diagnosis of indeterminate biliary stenosis in order to guide therapeutic management
Patients aged 18 to 85
Patient who gave his consent to participate in the study
No contraindication to anesthesia (ASA 1, 2,3)
Patient affiliated to a social security scheme (beneficiary or beneficiary)
Absence of pregnancy and current contraception in women of childbearing age

Exclusion Criteria:

Presence of a manifest tissue mass in relation to the biliary stenosis on CT and / or MRI imaging.
Very strong presumption of the etiological diagnosis of biliary stenosis given the history (history, background): i.e. liver surgery, cholecystectomy, autoimmunity
History of ERCP and / or percutaneous biliary drainage in the 6 months preceding inclusion
Presence of a plastic or metal biliary prosthesis in place at the time of inclusion
History of cephalic duodeno-pancreatectomy or hepatico-jejunal anastomosis
Non-passable stenosis of the main bile duct
Severe coagulopathy, thrombocytopenia <75,000 G / L, treatment with clopidogrel cannot be interrupted even temporarily
Anesthetic contraindication (ASA 4)
Inability to obtain informed consent
person deprived of liberty

Sites / Locations

Hôpital BeaujonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

cytological brushing followed by cholangioscopy in case of failure

cholangioscopy from the start

Arm Description

Outcomes

Primary Outcome Measures

Diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).

Diagnostic performance is expressed primarily by sensitivity for the diagnosis of malignancy.

Secondary Outcome Measures

Specific rate of diagnosis with cholangioscopy by spyglass used in 1st or 2nd intention

Rate of adverse events related to diagnostic procedures in each of the 2 groups

Comparison of the costs of the 2 diagnostic strategies

Full Information

NCT ID

NCT04840537

First Posted

April 7, 2021

Last Updated

April 7, 2021

Sponsor

Frederic PRAT, MD, PhD

1. Study Identification

Unique Protocol Identification Number

NCT04840537

Brief Title

Cholangioscopy or Conventional Techniques for Indeterminate Biliary Stenosis

Official Title

Comparison of Two Diagnostic Strategies in Indeterminate Biliary Stenosis: Exploration by Retrograde Cholangioscopy From the Outset or After Failure of Conventional Techniques

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 26, 2018 (Actual)

Primary Completion Date

December 26, 2018 (Actual)

Study Completion Date

December 26, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Frederic PRAT, MD, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Biliary stenosis not associated with a mass is difficult to diagnose with certainty. The diagnosis is usually based on a first-line cytological study of biliary brushing, which allows a diagnosis in 30 to 50% of cases. In the event of negativity, it is then possible to perform a cholangioscopy in a second step, which allows better sensitivity by performing biopsies. Performing cholangioscopy from the start could potentially save time and avoid disturbances associated with intermediate biliary stenting. The main objective is to compare two strategies for exploring indeterminate biliary stenosis (1st vs. 2nd line retrograde cholangioscopy) in terms of diagnostic performance. The secondary objectives are to compare the same two strategies in terms of effectiveness, side effects and cost-effectiveness. The primary outcome measure is the diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).

6. Conditions and Keywords

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

Malignant Biliary Stenosis

Keywords

biliary stenosis, cholangioscopy, cholangiocarcinoma, ERCP

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

cytological brushing followed by cholangioscopy in case of failure

Arm Type

Active Comparator

Arm Title

cholangioscopy from the start

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP

Intervention Description

endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure for exploration of an indeterminate biliary stenosis and biliary drainage

Primary Outcome Measure Information:

Title

Description

Diagnostic performance is expressed primarily by sensitivity for the diagnosis of malignancy.

Time Frame

48 months

Secondary Outcome Measure Information:

Title

Specific rate of diagnosis with cholangioscopy by spyglass used in 1st or 2nd intention

Time Frame

48 months

Title

Rate of adverse events related to diagnostic procedures in each of the 2 groups

Time Frame

48 months

Title

Comparison of the costs of the 2 diagnostic strategies

Time Frame

48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Presence of intra- or extrahepatic biliary stenosis, involving the main bile ducts: common hepatic duct, right and left hepatic ducts Presence of clinical jaundice and / or biological cholestasis (GGT> 3N) Absence of visible mass near the biliary stenosis after initial morphological assessment by abdominal CT scan, MRI with biliary sequences. Endoscopic ultrasound performed and not having allowed the acquisition of material of diagnostic interest by guided puncture of the lesion. No history of ERCP in the 6 months preceding inclusion and no biliary prosthesis (plastic or metal) in place at the time of inclusion Collegial validation of the need for a formal diagnosis of indeterminate biliary stenosis in order to guide therapeutic management Patients aged 18 to 85 Patient who gave his consent to participate in the study No contraindication to anesthesia (ASA 1, 2,3) Patient affiliated to a social security scheme (beneficiary or beneficiary) Absence of pregnancy and current contraception in women of childbearing age Exclusion Criteria: Presence of a manifest tissue mass in relation to the biliary stenosis on CT and / or MRI imaging. Very strong presumption of the etiological diagnosis of biliary stenosis given the history (history, background): i.e. liver surgery, cholecystectomy, autoimmunity History of ERCP and / or percutaneous biliary drainage in the 6 months preceding inclusion Presence of a plastic or metal biliary prosthesis in place at the time of inclusion History of cephalic duodeno-pancreatectomy or hepatico-jejunal anastomosis Non-passable stenosis of the main bile duct Severe coagulopathy, thrombocytopenia <75,000 G / L, treatment with clopidogrel cannot be interrupted even temporarily Anesthetic contraindication (ASA 4) Inability to obtain informed consent person deprived of liberty

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Frederic Prat, MD, PhD

Phone

+33 (0)140875663

frederic.prat@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Diane Lorenzo, MD

diane.lorenzo@aphp.fr

Facility Information:

Facility Name

Hôpital Beaujon

City

Clichy

ZIP/Postal Code

92110

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

frederic prat, MD, PhD

Phone

+33 (0)140875663

maximilien.barret@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Cholangioscopy or Conventional Techniques for Indeterminate Biliary Stenosis

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