Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-20

Study Completion Date

2021-12-13

Brief Summary

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The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.

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Detailed Description

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Conditions

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Pancreatic Carcinoma

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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WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent)

Group Type ACTIVE_COMPARATOR

WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

Intervention Type DEVICE

None (No Pre-Operative Biliary Drainage)

Patients in this group will not receive pre-operative biliary drainage with a study SEMS

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18 or older
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study
* Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required)
* Biliary obstructive symptoms or signs
* Bilirubin level at/above 100 umol per liter (5.8 mg/dL)
* Distal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy
* Location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2cm from the hilum
* Patients deemed as resectable by pancreatic protocol CT or MRI
* Surgical candidate per pancreatobiliary surgeon after multi-disciplinary discussion
* Surgery intent within 4 weeks
* Endoscopic and surgical treatment to be provided by same team

Exclusion Criteria

* Biliary strictures caused by confirmed benign tumors
* Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers
* Surgically altered biliary tract anatomy, not including prior cholecystectomy
* Neoadjuvant chemotherapy for current malignancy
* Palliative indication due to reasons other than surgical candidate status
* Previous biliary drainage by ERCP/PTC
* Patients for whom endoscopic techniques are contraindicated
* Participation in another investigational trial within 90 days
* Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No