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Completed

NCT Number: NCT01238900

Evaluation of the Use of Metal Stents as Part of the Treatment of Benign Biliary Strictures

The purpose of this study is to study the evaluation of the use of metal stents as part of the treatment of benign biliary strictures.

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Key information

Conditions

Benign Biliary Strictures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shands at UF endoscopy center

Gainesville, Florida, 32608, United States

About this study

In patients with benign biliary strictures, the use of fully covered self-expandable metal stents (SEMS) has been proposed as an alternative to plastic stenting, but high quality prospective data is sparse. This study was performed to evaluate the long -term effectiveness and safety of a new fully covered SEMS for benign biliary strictures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is 18 years or older
  • Subject has benign biliary stricture
  • Subject must be able to give informed consent

Exclusion criteria

  • Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
  • The subject is unable to give informed consent

Treatment and study plan

Endoscopic Retrograde Cholangiopancreatography (ERCP)

Procedure

Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of metal stent in the bile duct

Primary outcomes

  1. Short Term Success Rate in the Resolution of Biliary Strictures

    Time frame: 6 months

    Short-term success was defined as resolution of the stricture as documented by rapid drainage of contrast out of the proximal biliary tree and easy passage of stone extraction balloon inflated to the size of the proximal bile duct. If the biliary stricture had resolved at the 6-month follow-up ERCP, patients were classified as short-term success. If stricture was not resolved at 6-month ERCP then a new SEMS was placed; if the stricture had resolved at the time of the second stent removal, the patient was also classified as short-term success.

  2. Long-term Success Rate in Resolution of Biliary Strictures

    Time frame: at least 12 months after stent removal

    Long-term success was defined as no clinical evidence of recurrence of the biliary stricture during the follow-up period as documented by laboratory findings or imaging and no further need for further endoscopic or surgical interventions.

Secondary outcomes

  1. Number of Endoscopic Treatments Per Patient

    Time frame: At time of procedure

    The average number of ERCPs performed per patient required for resolution of benign strictures.

  2. Ease of Stent Removal

    Time frame: at time of procedure

    The ease of stent removal was graded on a 4-point scale (with ease, mild difficulty, significant difficulty, and failed).

  3. Frequency and Severity of Adverse Events (Including Stent Migration)

    Time frame: up to 12 months

    Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Prospective Evaluation of the Clinical Utility of Placement of Metal Stent for Benign Biliary Strictures

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Nov 11, 2010
Registry last updated
Oct 2, 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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