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Completed

NCT Number: NCT01457092

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)

Device

Placement of self-expandable metal stents

Primary outcomes

  1. Stricture dilatation

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 21, 2011
Registry last updated
Nov 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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