Biliary Stricture Clinical Trial
Official title:
Temporary Placement of Fully Covered Self-expandable Metal Stents in Benign Biliary Strictures
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.
Status | Completed |
Enrollment | 92 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 . Exclusion Criteria: - an uncertainty about the benign nature of the stricture - an intra-hepatic cholangitis and/ or a stricture extending beyond the hilum |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hôpital Cochin | Paris |
Lead Sponsor | Collaborator |
---|---|
Société Française d'Endoscopie Digestive |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Initial success rate of temporary FCMS placement | Absence of biliary stricture or as an attenuated stricture on cholangiogram after removal of FCMS | 6 months | No |
Secondary | Final success | Absence of biliary stricture or the presence of an attenuated stricture and normal liver function tests at the end of follow up. | 18 months | No |
Secondary | Stricture recurrence | Both clinically and ERCP-documented recurrence of stricture after an initial success. | 18 months | No |
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