SEMS Placement Before Surgery in Unblocking Bile Duct in Patients With Periampullary Pancreatic Cancer With Severe Obstructive Jaundice

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-04-04

Brief Summary

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This trial studies the side effects of self expanding metal stent (SEMS) placement before surgery in unblocking the bile duct in patients with periampullary pancreatic cancer with severe obstructive jaundice. SEMS placement unblocks the bile duct and may help in improving bile drainage prior to surgery in patients with periampullary pancreatic cancer with severe obstructive jaundice.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To compare the 30-day overall complication rates between patients with severe obstructive jaundice undergoing preoperative endoscopic biliary drainage with self expanding metal stents (SEMS) and patients undergoing direct surgical resection.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SEMS

Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.

Group Type EXPERIMENTAL

Endoscopic Retrograde Cholangiopancreatography

Intervention Type PROCEDURE

Undergo ERCP with SEMS placement

Standard of care surgical resection

Patients undergo standard of care surgical resection.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

Undergo standard of care surgical resection

Interventions

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Endoscopic Retrograde Cholangiopancreatography

Undergo ERCP with SEMS placement

Intervention Type PROCEDURE

Standard of care

Undergo standard of care surgical resection

Intervention Type OTHER

Other Intervention Names

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ERCP

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of operable peri-ampullary pancreatic cancer as determined by the Department of Surgery per their standard of care
* Serum bilirubin \> 10 mg/dl
* Adequate birth control

Exclusion Criteria

* Patients with evidence of distant metastasis on computed tomography (CT) or magnetic resonance imaging (MRI)
* Patients anticipated to require vascular reconstruction
* Patients with cholangitis
* Patients for whom surgery is deemed inappropriate by surgeon
* Patients with bilirubin less than 10 mg/dL or greater than 20 mg/dL
* Patients who previously underwent biliary decompression for cholangitis by ERCP or percutaneous transhepatic cholangiography (PTC)
* Patients with low performance score (Karnofsky performance status scale \< 50)
* Patients with known preexisting liver disease with associated elevated bilirubin
* Patients who are pregnant or actively breast feeding

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No