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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
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Biliary Strictures focused on measuring benign biliary strictures, chronic pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

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

    First Posted
    October 19, 2011
    Last Updated
    November 6, 2015
    Sponsor
    Catholic University of the Sacred Heart
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    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

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

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