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

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.

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FC Nitinol SEMS	Device: FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea); Placement of self-expandable metal stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Stricture dilatation	6 months

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimate): October 21, 2011

Study Record Updates

• Last Update Posted (Estimate): November 9, 2015
• Last Update Submitted That Met QC Criteria: November 6, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: chronic pancreatitis; benign biliary strictures
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Pancreatic Diseases; Bile Duct Diseases; Constriction, Pathologic; Pancreatitis; Pancreatitis, Chronic; Cholestasis
• Other Study ID Numbers: A/1530/2005