Cholangioscopy or Conventional Techniques for Indeterminate Biliary Stenosis

NCT ID: NCT04840537

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-26
• Study Completion Date: 2022-12-26

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).

Conditions

Malignant Biliary Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

cytological brushing followed by cholangioscopy in case of failure

Group Type: ACTIVE_COMPARATOR

endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP

Intervention Type: PROCEDURE

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

cholangioscopy from the start

Group Type: EXPERIMENTAL

endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Frederic PRAT, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Frederic PRAT, MD, PhD

Principal Investagator, Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hôpital Beaujon

Clichy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Frederic Prat, MD, PhD

Role: CONTACT

frederic.prat@aphp.fr

+33 (0)140875663

Diane Lorenzo, MD

Role: CONTACT

diane.lorenzo@aphp.fr

Facility Contacts

frederic prat, MD, PhD

Role: primary

maximilien.barret@aphp.fr

+33 (0)140875663

Other Identifiers

SFED 131

Identifier Type: -

Identifier Source: org_study_id