Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

Sponsor

AdventHealth (Other)

Overall Status

Completed

CT.gov ID

NCT01675908

Collaborator

Vanderbilt University (Other), University of Maryland, Baltimore (Other)

Enrollment

Location

Arms

83.9

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obstructive Jaundice Pancreatic Cancer	Procedure: Stent Dysfunction Procedure: Complications	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer

Actual Study Start Date :

Aug 22, 2012

Actual Primary Completion Date :

Aug 21, 2019

Actual Study Completion Date :

Aug 21, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Complications related to stent dysfunction [30 days]
Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.

Secondary Outcome Measures

Procedural complications [30 days]
This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:

Patients with pancreatic cancer and mass in the head of pancreas causing jaundice.
Patients 19 yrs of age and older
Serum bilirubin > 2mg/dl
CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin).

EXCLUSION CRITERIA:

Karnofsky score < 60
Prior (ERCP or PTC) attempts at biliary decompression for the same indication
Tumor-related gastric outlet obstruction (vomiting and oral intake of < 1L/day)
Ongoing or planned neoadjuvant therapy
Cholangitis at presentation or coagulopathy needing reversal medication
Post-surgical anatomy
Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum
Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida Hospital	Orlando	Florida	United States	32814

Sponsors and Collaborators

AdventHealth
Vanderbilt University
University of Maryland, Baltimore

Investigators

Principal Investigator: shyam varadarajulu, MD, Florida Hospital Center for Interventional Endoscopy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AdventHealth

ClinicalTrials.gov Identifier:

NCT01675908

Other Study ID Numbers:

356090

First Posted:

Aug 30, 2012

Last Update Posted:

Mar 3, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Pancreatic Neoplasms

Jaundice

Jaundice, Obstructive

Study Results

No Results Posted as of Mar 3, 2022