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

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ClinicalTrials.gov Identifier: NCT01457092
Recruitment Status : Completed
First Posted : October 21, 2011
Last Update Posted : November 9, 2015
Sponsor:
Information provided by (Responsible Party):
Guido Costamagna, Catholic University of the Sacred Heart

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.

Condition or disease Intervention/treatment Phase
Benign Biliary Strictures Chronic Pancreatitis Device: FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea) Not Applicable

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  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Stricture dilatation [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Responsible Party: Guido Costamagna, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01457092     History of Changes
Other Study ID Numbers: A/1530/2005
First Posted: October 21, 2011    Key Record Dates
Last Update Posted: November 9, 2015
Last Verified: November 2015

Keywords provided by Guido Costamagna, Catholic University of the Sacred Heart:
benign biliary strictures
chronic pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Constriction, Pathologic
Pancreatitis, Chronic
Cholestasis
Pancreatic Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases