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

NCT ID: NCT01457092

Last Updated: 2015-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-09-30

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.

Conditions

Benign Biliary Strictures; Chronic Pancreatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FC Nitinol SEMS

FC Nitinol SEMS

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Placement of self-expandable metal stents

Interventions

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

Placement of self-expandable metal stents

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Guido Costamagna

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

A/1530/2005

Identifier Type: -

Identifier Source: org_study_id