Completed

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

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What is being tested

Stent Dysfunction

+ Complications

+ Stent Dysfunction

Procedure
Who is being recruted

Digestive System Diseases+12

+ Digestive System Neoplasms

+ Endocrine System Diseases

Over 19 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorAdventHealth
Last updated: March 3, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: August 22, 2012

Actual date on which the first participant was enrolled.

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.

NCT01675908
Principal SponsorAdventHealth
Last updated: March 3, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsHyperbilirubinemiaJaundiceNeoplasmsNeoplasms by SitePancreatic DiseasesPathologic ProcessesSigns and SymptomsSkin ManifestationsPathological Conditions, Signs and SymptomsPancreatic NeoplasmsJaundice, Obstructive

Criteria

4 inclusion criteria required to participate
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)
Patients 19 yrs of age and older
Patients with pancreatic cancer and mass in the head of pancreas causing jaundice
Serum bilirubin > 2mg/dl
8 exclusion criteria prevent from participating
Cholangitis at presentation or coagulopathy needing reversal medication
Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery)
Karnofsky score < 60
Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Florida Hospital

Orlando, United StatesOpen Florida Hospital in Google Maps
CompletedOne Study Center