Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2022-10-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obstructive Jaundice Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metal stent

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

Group Type ACTIVE_COMPARATOR

Metal stent

Intervention Type PROCEDURE

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

Plastic Stent

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

Group Type ACTIVE_COMPARATOR

Plastic stent

Intervention Type PROCEDURE

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

Interventions

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Metal stent

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

Intervention Type PROCEDURE

Plastic stent

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

Intervention Type PROCEDURE

Eligibility Criteria

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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).

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).

Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No