Fully Covered Self-expandable Metal Stents (FCMS) in Benign Biliary Strictures

NCT02105181 | Completed

• 1 other identifier: 2006-A00197-44
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic treatment of benign biliary strictures can be challenging. Balloon dilation and/or plastic stent placement are currently the most popular techniques. Partially covered self-expandable metallic stents have also shown to be effective but can be difficult to remove. A novel fully covered metallic stent has recently been developed. The aim of this study was to prospectively evaluate the placement of fully covered self-expandable metallic stents (FCSEMS) in this setting.

Conditions

Biliary Stricture

Keywords

benign biliary stricture; anastomotic biliary stricture after liver transplantation; chronic pancreatitis; biliary surgical procedure; fully covered metal stent

Outcome Measures

Primary Outcomes (1)

• Initial success rate of temporary FCMS placement

  Absence of biliary stricture or as an attenuated stricture on cholangiogram after removal of FCMS

  6 months

Secondary Outcomes (2)

• Final success

  18 months

• Stricture recurrence

  18 months

Study Arms (1)

Fully covered metal stent (FCMS)

OTHER

There is one arm in the study : the intervention consists on placing a device which is a fully covered metal stent in the biliary tract of all patients

Device: Placement of a FCMS in the biliary tract of the patients

Interventions

Placement of a FCMS in the biliary tract of the patients DEVICE

During an ERCP procedure, a fully covered biliary metal stent (FCMS) is placed across a benign biliary stricture

Fully covered metal stent (FCMS)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• a history of liver transplantation, chronic pancreatitis or biliary surgery
• impairment of liver function tests such as elevated liver enzymes and/or cholestasis
• a biliary stricture associated with ductal dilation detected by US, CT or MRI, with a minimum distance of 2cm between the upper stricture's edge and the lower limit of the main biliary confluence or liver hilum .

You may not qualify if:

• an uncertainty about the benign nature of the stricture
• an intra-hepatic cholangitis and/ or a stricture extending beyond the hilum

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frederic Prat, MD, PhD

  Société Française d'Endoscopie Digestive

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Ulriikka Chaput

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 7, 2014
• Study Start: March 1, 2007
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

FR (1)