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

NCT01238900 | Completed Results

• 1 other identifier: Benign Biliary Strictures
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Biliary Strictures

Outcome Measures

Primary Outcomes (2)

• Short Term Success Rate in the Resolution of Biliary Strictures

  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.

  6 months

• Long-term Success Rate in Resolution of Biliary Strictures

  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.

  at least 12 months after stent removal

Secondary Outcomes (3)

• Number of Endoscopic Treatments Per Patient

  At time of procedure

• Ease of Stent Removal

  at time of procedure

• Frequency and Severity of Adverse Events (Including Stent Migration)

  up to 12 months

Study Arms (1)

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)

Interventions

Endoscopic Retrograde Cholangiopancreatography (ERCP) PROCEDURE

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

benign biliary strictures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Shands at UF endoscopy center

Gainesville, Florida, 32608, United States

Location

Related Publications (1)

• 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.

  PMID: 23956613 DERIVED

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Limitations and Caveats

Fifty-six percent of our patients had prior therapy for their benign biliary stricture; therefore they were not treatment naive. High prevalence of CP-related strictures which are known to be more difficult to treat.

Results Point of Contact

• Title: Dr. Peter V. Draganov
• Organization: University of Florida

Peter.Draganov@medicine.ufl.edu

(352) 273-9472

Study Officials

• Peter Draganov, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 11, 2010
• Study Start: May 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 2, 2015
• Results First Posted: October 2, 2015

Record last verified: 2015-08

Locations

US (1)