Preoperative Biliary Drainage In Resectable Pancreatic Or Periampullary Cancer

Study Overview

Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

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.

N/A

Pancreatic Carcinoma

DEVICE: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

90914721
E7059 (OTHER Identifier) (OTHER: Boston Scientific)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-10-02	Results First Submitted 2022-12-07	Last Update Submitted that met QC Criteria 2023-04-07
First Submitted that Met QC Criteria 2013-01-18	Results First Submitted that Met QC Criteria 2023-04-07	Last Update Posted (ACTUAL) 2023-04-10
First Posted (ACTUAL) 2013-01-23	Results First Posted 2023-04-10	Last Verified 2023-04

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: 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)	DEVICE: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
NO_INTERVENTION: None (No Pre-Operative Biliary Drainage) Patients in this group will not receive pre-operative biliary drainage with a study SEMS

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: 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)

DEVICE: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

NO_INTERVENTION: None (No Pre-Operative Biliary Drainage)

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

Primary Outcome Measures	Measure Description	Time Frame
Number of Serious Pre-operative, Operative and Post-operative Adverse Events to 120 Days Post Randomization or to 30 Days Post Surgery, Whichever Comes Last	The primary end point was all serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	120 to 150 days

Secondary Outcome Measures	Measure Description	Time Frame
Stent Placement Success	Stent placement success: ability to deploy the stent in satisfactory position across the stricture (For patients who are randomized to biliary drainage with a metal stent)	Procedure
Number of Patients With Biliary Re-interventions	Count of patients with biliary interventions after baseline	120 to 150 days
Success Rate of Curative Intent Surgery	This is the number of patients that had successful resection	4 weeks
All-cause Mortality	Mortality which occurs within 150 days of baseline	150 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Guido Costamagna, MD, Fondazione Policlinico Universitario Agostino Gemelli

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record