Biliary Anastomotic Stenosis, Biliary Stricture
Conditions
Keywords
biliary anastomotic stricture, orthotopic liver transplantation, ERCP
Brief summary
Biliary complications are one of the most common problems after orthotopic liver transplantation (OLT),occurring in up to 24% of patients. Anastomotic strictures have been endoscopically managed with plastic stents placement. Recently, partially and fully covered metal stents have been alternatively used to treat refractory benign biliary stenosis. The investigators purpose is to compare efficacy and safety of metallic stents versus multiple plastic stents in the endoscopic management of post transplant biliary complications.
Detailed description
Patients with biliary stricture after OLT will be randomly assigned following simple randomization to temporary placement of fully covered self-expandable metal stent (SEMS) or multiple plastic stents placement were randomized according to a computer generated randomization sequence and allocated in a 1:1 ratio to one of two treatment groups. Final success will be defined as clinical resolution of the stricture without the need to repeat endoscopic, percutaneous or surgical treatment.
Interventions
DEVICESelf-expandable metalic stent
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
DEVICEMultiple plastic stents
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
Sponsors
Hospital Israelita Albert Einstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* post-OLT biliary anastomotic stenosis (at least 1 month post-operative) * jaundice, cholestasis and/or biliary tree dilation on US
Exclusion criteria
* biliary fistulae * non-anastomotic stricture * combine anastomotic and non-anastomotic stricture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post OLT biliary stricture resolution after stent removal | Up to 1 year | Post OLT biliary stricture resolution will be evaluated during endoscopic stents removal up to 1 year after initial stents placement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained improvement after endoscopic treatment | 1 year after biliary stenosis resolution | Stricture resolution persistent after 1 year |
| Occurence and severity of complications related to the endoscopic procedures | Up to 1 month | Occurence and severity of complications after therapeutic ERCP will be evaluated and recorded up to 1 month after endoscopic procedures. |
Countries
Brazil
Outcome results
None listed