Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression

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

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 Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Obstructive Jaundice
• Intervention / Treatment: Procedure: Metal stent; Procedure: Plastic stent

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

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32814
      • AdventHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metal stent; Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.	Procedure: Metal stent; Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.
Active Comparator: Plastic Stent; Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a plastic stent	Procedure: Plastic stent; Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a 10Fr plastic stent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural complications	Complications related to the procedure which includes pancreatitis, perforation or hemorrhage.	30 days

Collaborators and Investigators

• Sponsor: AdventHealth
• Collaborators: University of Virginia
• Investigators: Principal Investigator: Muhammad Hasan, MD, AdventHealth

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): October 13, 2022
• Study Completion (Actual): October 13, 2022

Study Registration Dates

• First Submitted: August 12, 2010
• First Submitted That Met QC Criteria: August 30, 2010
• First Posted (Estimated): August 31, 2010

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: pancreatic cancer; obstructive jaundice; Obstructive jaundice secondary to pancreatic cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Skin Manifestations; Pancreatic Diseases; Hyperbilirubinemia; Pancreatic Neoplasms; Jaundice; Jaundice, Obstructive
• Other Study ID Numbers: FT356090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A manuscript will be developed following the closure of the study.