Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis
Primary Purpose
Benign Biliary Strictures, Chronic Pancreatitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)
Sponsored by
About this trial
This is an interventional treatment trial for Benign Biliary Strictures focused on measuring benign biliary strictures, chronic pancreatitis
Eligibility Criteria
Inclusion Criteria:
- age ≥18 years,
- 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
- patient unfit for surgery (portal cavernomatosis, comorbidities) or patient refusal of surgery.
Exclusion Criteria:
- benign biliary strictures secondary to compression from a pancreatic pseudocyst;
- patients with associated pancreatic neoplasia
- ongoing alcohol abuse (ethanol > 80 g/day).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FC Nitinol SEMS
Arm Description
FC Nitinol SEMS
Outcomes
Primary Outcome Measures
Stricture dilatation
Secondary Outcome Measures
Full Information
NCT ID
NCT01457092
First Posted
October 19, 2011
Last Updated
November 6, 2015
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT01457092
Brief Title
Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis
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 Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Biliary Strictures, Chronic Pancreatitis
Keywords
benign biliary strictures, chronic pancreatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FC Nitinol SEMS
Arm Type
Experimental
Arm Description
FC Nitinol SEMS
Intervention Type
Device
Intervention Name(s)
FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)
Intervention Description
Placement of self-expandable metal stents
Primary Outcome Measure Information:
Title
Stricture dilatation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥18 years,
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
patient unfit for surgery (portal cavernomatosis, comorbidities) or patient refusal of surgery.
Exclusion Criteria:
benign biliary strictures secondary to compression from a pancreatic pseudocyst;
patients with associated pancreatic neoplasia
ongoing alcohol abuse (ethanol > 80 g/day).
12. IPD Sharing Statement
Learn more about this trial
Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis
We'll reach out to this number within 24 hrs