Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis

Not Applicable

Completed

• Conditions: Benign Biliary Strictures; Chronic Pancreatitis
• Interventions: Device: FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)

• Registration Number: NCT01457092
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

The purpose of the study was to analyze the resolution rate of benign biliary strictures due to chronic pancreatitis after temporary insertion of unflared-ends and flared-ends fully covered self-expandable metal stents.

Detailed Description

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 Timeline

• Study Start: 2007-01
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-21
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-06
• Last Update Posted: 2015-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. age ≥18 years,
2. symptomatic (persistent cholestasis, jaundice, cholangitis) common bile duct strictures secondary to CP, that persist 3 months or more after placement of a single 10 French plastic stent and
3. patient unfit for surgery (portal cavernomatosis, comorbidities) or patient refusal of surgery.

Exclusion Criteria

1. benign biliary strictures secondary to compression from a pancreatic pseudocyst;
2. patients with associated pancreatic neoplasia
3. ongoing alcohol abuse (ethanol > 80 g/day).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FC Nitinol SEMS	FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)	FC Nitinol SEMS

Primary Outcome Measures

Name	Time	Method
Stricture dilatation	6 months