Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis
|ClinicalTrials.gov Identifier: NCT01457092|
Recruitment Status : Completed
First Posted : October 21, 2011
Last Update Posted : November 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Benign Biliary Strictures Chronic Pancreatitis||Device: FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)||Not Applicable|
Endoscopic treatment of benign biliary strictures include the placement of plastic stents or Self-Expandable Metal Stents. Long term results of placement of a single plastic stent are disappointing. Better results have been obtained by endoscopic insertion of multiple plastic stents.
Biliary Self-Expandable Metal Stents used for malignant strictures are uncovered or partially covered with a plastic coating. More recently, fully covered SEMS have been developed and are now available on the market and due to their removability are proposed also for benign indications.
Uncovered and partially covered biliary Self-Expandable Metal Stents for chronic pancreatitis-related benign biliary strictures on long-term may clog due to tissue ingrowth through the uncovered meshes.
Removable fully covered Self-Expandable Metal Stents seem to be an attractive option for CP-related BBS, but scarce data are available in the literature.
The investigators conducted a feasibility, prospective, tertiary single-centre trial to investigate the durable resolution of chronic pancreatitis-related benign biliary strictures after temporary insertion of FC SEMS with unflared-ends and flared-ends.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis Not Responding to Plastic Stenting: a Prospective Study With Two Years Follow-up.|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Experimental: FC Nitinol SEMS
FC Nitinol SEMS
Device: FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)
Placement of self-expandable metal stents
- Stricture dilatation [ Time Frame: 6 months ]