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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment
Benign Biliary Strictures	Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)

Detailed Description:

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	23 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Prospective Evaluation of the Clinical Utility of Placement of Metal Stent for Benign Biliary Strictures
Study Start Date :	May 2009
Actual Primary Completion Date :	May 2015
Actual Study Completion Date :	May 2015

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
benign biliary strictures; All patients who have a medical indication for an ERCP to place a stent in their benign biliary strictures	Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP); Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of metal stent in the bile duct

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients who have a medical indication for endoscopic therapy of benign biliary stictures and are referred for the procedure as part of their standard medical care will be considered for the study.

Criteria

Inclusion Criteria:

1. Subject is 18 years or older
2. Subject has benign biliary stricture
3. Subject must be able to give informed consent

Exclusion Criteria:

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Florida
Shands at UF endoscopy center
Gainesville, Florida, United States, 32608

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:	Peter Draganov, MD	University of Florida

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wagh MS, Chavalitdhamrong D, Moezardalan K, Chauhan SS, Gupte AR, Nosler MJ, Forsmark CE, Draganov PV. Effectiveness and safety of endoscopic treatment of benign biliary strictures using a new fully covered self expandable metal stent. Diagn Ther Endosc. 2013;2013:183513. doi: 10.1155/2013/183513. Epub 2013 May 11.

Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT01238900 History of Changes
Other Study ID Numbers:	Benign Biliary Strictures
First Posted:	November 11, 2010
Results First Posted:	October 2, 2015
Last Update Posted:	October 2, 2015
Last Verified:	August 2015

Additional relevant MeSH terms:

Constriction, Pathologic; Cholestasis; Pathological Conditions, Anatomical	Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases