Biliary Stricture
Conditions
Keywords
benign biliary stricture, anastomotic biliary stricture after liver transplantation, chronic pancreatitis, biliary surgical procedure, fully covered metal stent
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.
Detailed description
After inclusion, an endoscopic procedure (ERCP) was performed in all patients in order to place a FCMS across the benign biliary stricture. The FCMS was left in place for 6 months and then extracted during a second ERCP procedure. An opacification was performed to assess the efficacy of stenting. Patients were followed up during one year after FCMS extraction.
Interventions
DEVICEPlacement of a FCMS in the biliary tract of the patients
During an ERCP procedure, a fully covered biliary metal stent (FCMS) is placed across a benign biliary stricture
Sponsors
Société Française d'Endoscopie Digestive
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial success rate of temporary FCMS placement | 6 months | Absence of biliary stricture or as an attenuated stricture on cholangiogram after removal of FCMS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Final success | 18 months | Absence of biliary stricture or the presence of an attenuated stricture and normal liver function tests at the end of follow up. |
| Stricture recurrence | 18 months | Both clinically and ERCP-documented recurrence of stricture after an initial success. |
Countries
France
Outcome results
None listed