Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

NCT01675908 | Completed DMC

• 1 other identifier: 356090
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Jaundice; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Complications related to stent dysfunction

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

  30 days

Secondary Outcomes (1)

• Procedural complications

  30 days

Study Arms (2)

Metal stent

ACTIVE COMPARATOR

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; Procedure: Complications

Plastic Stent

ACTIVE COMPARATOR

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; Procedure: Complications

Interventions

Stent Dysfunction PROCEDURE

Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.

Metal stent; Plastic Stent

Complications PROCEDURE

Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.

Metal stent; Plastic Stent

Eligibility Criteria

• Age: 19 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
• Vanderbilt University: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (1)

Florida Hospital

Orlando, Florida, 32814, United States

Location

MeSH Terms

Conditions

Jaundice, Obstructive; Pancreatic Neoplasms

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

Study Officials

• shyam varadarajulu, MD

  Florida Hospital Center for Interventional Endoscopy

  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 28, 2012
• First Posted: August 30, 2012
• Study Start: August 22, 2012
• Primary Completion: August 21, 2019
• Study Completion: August 21, 2019
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)