Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression

NCT01191814 | Completed DMC

• 1 other identifier: FT356090
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Jaundice; Pancreatic Cancer

Keywords

pancreatic cancer; obstructive jaundice; Obstructive jaundice secondary to pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Procedural complications

  30 days

Study Arms (2)

Metal stent

ACTIVE COMPARATOR

Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.

Procedure: Metal stent

Plastic Stent

ACTIVE COMPARATOR

Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a plastic stent

Procedure: Plastic stent

Interventions

Metal stent PROCEDURE

Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.

Metal stent

Plastic stent PROCEDURE

Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a 10Fr plastic stent.

Plastic Stent

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• AdventHealth: lead
• University of Virginia: collaborator

Study Sites (1)

AdventHealth

Orlando, Florida, 32814, United States

Location

MeSH Terms

Conditions

Jaundice, Obstructive; Pancreatic Neoplasms

Interventions

Self Expandable Metallic Stents

Condition Hierarchy (Ancestors)

Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Muhammad Hasan, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 31, 2010
• Study Start: July 1, 2010
• Primary Completion: October 13, 2022
• Study Completion: October 13, 2022
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)