Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
Primary Purpose
Pancreatic Carcinoma
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Carcinoma focused on measuring Pancreatic, Periampullary Cancer, Preoperative Biliary Drainage, Resectable
Eligibility Criteria
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
Sites / Locations
- Standford University Medical Center
- Westmead Hospital
- ULB Erasme Hospital
- Beijing Friendship Hospital
- Xijing Hospital of Digestive Diseases Fourth Military Medical University
- Hopital Edouard Herriot
- Queen Elizabeth Hospital
- Prince of Wales Hospital, the Chinese University of Hong Kong
- Asian Institute of Gastroenterology
- Fondazione Policlinico Universitario Agostino Gemelli
- Tokyo Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
None (No Pre-Operative Biliary Drainage)
Arm Description
Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent)
Patients in this group will not receive pre-operative biliary drainage with a study SEMS
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Number of Patients With Biliary Re-interventions
Count of patients with biliary interventions after baseline
Success Rate of Curative Intent Surgery
This is the number of patients that had successful resection
All-cause Mortality
Mortality which occurs within 150 days of baseline
Full Information
NCT ID
NCT01774019
First Posted
October 2, 2012
Last Updated
April 7, 2023
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01774019
Brief Title
Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
Official Title
Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2013 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
December 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Carcinoma
Keywords
Pancreatic, Periampullary Cancer, Preoperative Biliary Drainage, Resectable
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
Arm Type
Active Comparator
Arm Description
Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent)
Arm Title
None (No Pre-Operative Biliary Drainage)
Arm Type
No Intervention
Arm Description
Patients in this group will not receive pre-operative biliary drainage with a study SEMS
Intervention Type
Device
Intervention Name(s)
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
120 to 150 days
Secondary Outcome Measure Information:
Title
Stent Placement Success
Description
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)
Time Frame
Procedure
Title
Number of Patients With Biliary Re-interventions
Description
Count of patients with biliary interventions after baseline
Time Frame
120 to 150 days
Title
Success Rate of Curative Intent Surgery
Description
This is the number of patients that had successful resection
Time Frame
4 weeks
Title
All-cause Mortality
Description
Mortality which occurs within 150 days of baseline
Time Frame
150 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Costamagna, MD
Organizational Affiliation
Fondazione Policlinico Universitario Agostino Gemelli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Standford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
ULB Erasme Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Beijing Friendship Hospital
City
Beijing
Country
China
Facility Name
Xijing Hospital of Digestive Diseases Fourth Military Medical University
City
Xi'an
Country
China
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Queen Elizabeth Hospital
City
Kowloon
Country
Hong Kong
Facility Name
Prince of Wales Hospital, the Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong
Facility Name
Asian Institute of Gastroenterology
City
Hyderabad
ZIP/Postal Code
500 082
Country
India
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Tokyo Medical University
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
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