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

This study has been completed.
Information provided by (Responsible Party):
Guido Costamagna, Catholic University of the Sacred Heart Identifier:
First received: October 19, 2011
Last updated: November 6, 2015
Last verified: November 2015
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 Intervention
Benign Biliary Strictures
Chronic Pancreatitis
Device: FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Stricture dilatation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: January 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FC Nitinol SEMS
FC Nitinol SEMS
Device: FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)
Placement of 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
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Responsible Party: Guido Costamagna, Professor, Catholic University of the Sacred Heart Identifier: NCT01457092     History of Changes
Other Study ID Numbers: A/1530/2005
Study First Received: October 19, 2011
Last Updated: November 6, 2015
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Constriction, Pathologic
Pancreatitis, Chronic
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Pancreatic Diseases
Pathological Conditions, Anatomical processed this record on November 27, 2015