Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191814
• Other study ID #: FT356090
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: October 13, 2022

Study information

• Verified date: July 2023
• Source: AdventHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 as there will be better drainage of the obstructed biliary system with fewer adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 13, 2022
• Est. primary completion date: October 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Obstructive
• Obstructive Jaundice
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Metal stent
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.
• Plastic stent
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a 10Fr plastic stent.

Locations

Country	Name	City	State
United States	AdventHealth	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
AdventHealth	University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications related to stent dysfunction	Complications related to stent dysfunction which include hyperbilirubinemia or cholangitis that warrant stent exchange (repeat intervention by ERCP)	30 days
Secondary	Procedural complications	Complications related to the procedure which includes pancreatitis, perforation or hemorrhage.	30 days