Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression

Not Applicable

Completed

• Conditions: Pancreatic Cancer; Obstructive Jaundice
• Interventions: Procedure: Metal stent; Procedure: Plastic stent

• Registration Number: NCT01191814
• Lead Sponsor: AdventHealth

Brief 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.

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-12
• Study First Submitted QC: 2010-08-30
• Study First Posted: 2010-08-31
• Primary Completion: 2022-10-13
• Study Completion: 2022-10-13
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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).

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metal stent	Metal stent	Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.
Plastic Stent	Plastic stent	Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a plastic stent

Primary Outcome Measures

Name	Time	Method
Complications related to stent dysfunction	30 days	Complications related to stent dysfunction which include hyperbilirubinemia or cholangitis that warrant stent exchange (repeat intervention by ERCP)

Secondary Outcome Measures

Name	Time	Method
Procedural complications	30 days	Complications related to the procedure which includes pancreatitis, perforation or hemorrhage.

Trial Locations

Locations (1)

AdventHealth; 🇺🇸 Orlando, Florida, United States