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

Chronic Pancreatitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457092
• Other study ID #: A/1530/2005
• Status: Completed
• Phase: N/A
• First received: October 19, 2011
• Last updated: November 6, 2015
• Start date: January 2007
• Est. completion date: September 2009

Study information

• Verified date: November 2015
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Biliary Strictures
• Cholestasis
• Chronic Pancreatitis
• Constriction, Pathologic
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Device:
• FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)
Placement of self-expandable metal stents

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stricture dilatation		6 months	Yes