Cholangioscopy or Conventional Techniques for Indeterminate Biliary Stenosis

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

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).

Study Overview

• Status: Recruiting
• Conditions: Malignant Biliary Stenosis
• Intervention / Treatment: Procedure: endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frederic Prat, MD, PhD; Phone Number: +33 (0)140875663; Email: frederic.prat@aphp.fr
• Study Contact Backup: Name: Diane Lorenzo, MD; Email: diane.lorenzo@aphp.fr

Study Locations

• France
  • Clichy, France, 92110
    • Recruiting
    • Hopital Beaujon
    • Contact: frederic prat, MD, PhD; Phone Number: +33 (0)140875663; Email: maximilien.barret@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: cytological brushing followed by cholangioscopy in case of failure	Procedure: endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP; endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure for exploration of an indeterminate biliary stenosis and biliary drainage
Experimental: cholangioscopy from the start	Procedure: endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP; endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure for exploration of an indeterminate biliary stenosis and biliary drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Specific rate of diagnosis with cholangioscopy by spyglass used in 1st or 2nd intention	48 months
Rate of adverse events related to diagnostic procedures in each of the 2 groups	48 months
Comparison of the costs of the 2 diagnostic strategies	48 months

Collaborators and Investigators

• Sponsor: Frederic PRAT, MD, PhD

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2018
• Primary Completion (Actual): December 26, 2018
• Study Completion (Anticipated): December 26, 2022

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: cholangiocarcinoma; ERCP; cholangioscopy; biliary stenosis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: SFED 131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No