Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675908
• Other study ID #: 356090
• Status: Completed
• Phase: N/A
• Start date: August 22, 2012
• Est. completion date: August 21, 2019

Study information

• Verified date: February 2022
• Source: AdventHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 21, 2019
• Est. primary completion date: August 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

INCLUSION CRITERIA:

1. Patients with pancreatic cancer and mass in the head of pancreas causing jaundice.

2. Patients 19 yrs of age and older

3. Serum bilirubin > 2mg/dl

4. 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:

1. Karnofsky score < 60

2. Prior (ERCP or PTC) attempts at biliary decompression for the same indication

3. Tumor-related gastric outlet obstruction (vomiting and oral intake of < 1L/day)

4. Ongoing or planned neoadjuvant therapy

5. Cholangitis at presentation or coagulopathy needing reversal medication

6. Post-surgical anatomy

7. Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum

8. 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:
• Stent Dysfunction
Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.
• Complications
Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.

Locations

Country	Name	City	State
United States	Florida Hospital	Orlando	Florida

Sponsors (3)

Lead Sponsor	Collaborator
AdventHealth	University of Maryland, Baltimore, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Procedural complications	This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage.	30 days