Trial Comparing Metal Versus Plastic Stents For Preoperative Biliary Decompression

Study Overview

Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression

Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.

Obstructive Jaundice
Pancreatic Cancer

PROCEDURE: Stent Dysfunction
PROCEDURE: Complications

356090

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-08-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-02-15
First Submitted that Met QC Criteria 2012-08-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-03-03
First Posted (ACTUAL) 2012-08-30	Results First Posted N/A	Last Verified 2022-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Metal stent Patients randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated.	PROCEDURE: Stent Dysfunction Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP. PROCEDURE: Complications Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.
ACTIVE_COMPARATOR: Plastic Stent At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated.	PROCEDURE: Stent Dysfunction Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP. PROCEDURE: Complications Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Metal stent

Patients randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated.

PROCEDURE: Stent Dysfunction

Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.

PROCEDURE: Complications

Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.

ACTIVE_COMPARATOR: Plastic Stent

At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated.

PROCEDURE: Stent Dysfunction

Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.

PROCEDURE: Complications

Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.

Primary Outcome Measures	Measure Description	Time Frame
Complications related to stent dysfunction	Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.	30 days

Secondary Outcome Measures	Measure Description	Time Frame
Procedural complications	This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage.	30 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Vanderbilt University
University of Maryland, Baltimore

Investigators

PRINCIPAL_INVESTIGATOR: shyam varadarajulu, MD, Florida Hospital Center for Interventional Endoscopy

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record