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Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

This study is currently recruiting participants.
Verified October 2017 by Boston Scientific Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774019
First Posted: January 23, 2013
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose
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.

Condition Intervention Phase
Pancreatic Carcinoma Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer

Further study details as provided by Boston Scientific Corporation:

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 [ Time Frame: 120 days ]

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: Procedure - 120 days ]
    Adverse events will be assessed in terms of rate, severity, seriousness, relatedness to stent or endoscopic or surgical procedure, impact on time of surgery, length of hospitalization and ICU stay.

  • Time to surgery [ Time Frame: Baseline to 4 weeks ]
  • Curative Intent Surgery details pertaining to intraoperative assessment of resectability, surgical resection and reconstruction techniques. [ Time Frame: Baseline to 4 weeks ]
  • Amount of intraoperative blood loss and number of blood transfusions, duration of surgery [ Time Frame: At time of surgery ]
  • Biliary obstructive symptoms assessment [ Time Frame: Baseline - 120 days ]
  • Improvement of liver function test (LFT) levels as relative to baseline [ Time Frame: Week 2 - 120 days ]
  • Stent placement success [ Time Frame: Procedure ]
    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)

  • Stent removal success [ Time Frame: At time of surgery or prior to surgery if re-intervention is needed. ]
    Stent removal success: successful SEMS removal, either en bloc at time of surgery or endoscopically prior to surgery without stent removal related SAEs (For patients who are randomized to biliary drainage with a metal stent)

  • Number, type, reason, and timing of biliary re-interventions [ Time Frame: Baseline - 120 days ]
  • Number of hospital and ICU admissions [ Time Frame: Procedure - 120 days ]
  • Duration of hospital and ICU admissions [ Time Frame: Procedure - 120 days ]

Estimated Enrollment: 294
Actual Study Start Date: February 20, 2013
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774019


Contacts
Contact: Nguyet Labenski 508-683-4065 nguyet.labenski@bsci.com
Contact: Talia Romano 508-683-6132 talia.romano@bsci.com

Locations
United States, California
Standford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Nicholas Oberhelman       noberhl@stanford.edu   
Principal Investigator: Brendan Visser, MD         
United States, Indiana
Indiana University Medical Center Withdrawn
Indianapolis, Indiana, United States, 46202
Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Michael Bourke, MD    61-2-96891536    michael@citywestgastro.com.au   
Contact: Kathleen Goodrick       kathleen.goodrick@gmail.com   
Principal Investigator: Michael Bourke, MD         
Belgium
ULB Erasme Hospital Recruiting
Brussels, Belgium, 1070
Contact: Mona Hammam    32 25 55 36 22    Mona.Hammam@erasme.ulb.ac.be   
Principal Investigator: Jacques Devière, MD         
Canada, Quebec
Centre hospitalier de l Université de Montréal Withdrawn
Montreal, Quebec, Canada, H2X 3J4
China, Hong Kong
Queen Elizabeth Hospital Recruiting
Kowloon, Hong Kong, China
Contact: Bing Yee Suen       suenbingyee@surgery.cuhk.edu.hk   
Principal Investigator: Nam-Hung Chia, MD         
China
Prince of Wales Hospital, the Chinese University of Hong Kong Recruiting
Hong Kong, China
Contact: Bing Yee Suen       suenbingyee@surgery.cuhk.edu.hk   
Principal Investigator: James Lau, MD         
France
Hopital Edouard Herriot Recruiting
Lyon, France, 69437
Principal Investigator: Thierry Ponchon, MD         
India
Asian Institute of Gastroenterology Recruiting
Hyderabad, India, 500 082
Contact: Sana Fatima       sana.aigindia@gmail.com   
Contact: Ashish Kumar       ashish.aigindia@gmail.com   
Principal Investigator: Nageshwar Reddy, MD         
Italy
Fondazione Policlinico Universitario Agostino Gemelli Recruiting
Rome, Italy, 00168
Contact: Carolina Gualtieri    +390630156580    carolina.gualtieri@policlinicogemelli.it   
Contact: Andrea Tringali, MD       andrea.tringali@unicatt.it   
Principal Investigator: Guido Costamagna, MD         
Japan
Tokyo Medical University Recruiting
Tokyo, Japan, 160-0023
Contact: Takao Itoi, MD    81-3-33426111    itoi@tokyo-med.ac.jp   
Contact: Shuntaro Mukai, MD       maezora1031@yahoo.co.jp   
Principal Investigator: Takao Itoi, MD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Guido Costamagna, MD Fondazione Policlinico Universitario Agostino Gemelli
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01774019     History of Changes
Other Study ID Numbers: 90914721
E7059 ( Other Identifier: Boston Scientific )
First Submitted: October 2, 2012
First Posted: January 23, 2013
Last Update Posted: October 18, 2017
Last Verified: October 2017

Keywords provided by Boston Scientific Corporation:
Pancreatic
Periampullary Cancer
Preoperative Biliary Drainage
Resectable

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases