Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01774019
First received: October 2, 2012
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) improves 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: Procedure - 120 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Curative Intent Surgery details pertaining to intraoperative assessment of resectability, surgical resection and reconstruction techniques. [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
  • Amount of intraoperative blood loss and number of blood transfusions, duration of surgery [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
  • Biliary obstructive symptoms assessment [ Time Frame: Baseline - 120 days ] [ Designated as safety issue: No ]
  • Improvement of liver function test (LFT) levels as relative to baseline [ Time Frame: Week 2 - 120 days ] [ Designated as safety issue: No ]
  • Stent placement success [ Time Frame: Procedure ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of hospital and ICU admissions [ Time Frame: Procedure - 120 days ] [ Designated as safety issue: No ]
  • Duration of hospital and ICU admissions [ Time Frame: Procedure - 120 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 294
Study Start Date: February 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: November 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774019

Contacts
Contact: Lina Ginnetti 508-683-4512 lina.ginnetti@bsci.com
Contact: Nguyet Nguyen 508-683-4065 nguyet.nguyen2@bsci.com

Locations
Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Rebecca Sonson    +61 411 533 126    bec2153@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-Saint-Luc Hospital Recruiting
Montreal, Quebec, Canada, H2X 3J4
Contact: Josée Gagnon    514-890-8000 ext 35806    j.gagnon.chum@ssss.gouv.qc.ca   
Principal Investigator: André Roy, MD         
China
Prince of Wales Hospital, the Chinese University of Hong Kong Recruiting
Hong Kong, China
Contact: Kim Au       kimau@surgery.cuhk.edu.hk   
Principal Investigator: James Lau, MD         
France
Hopital Edouard Herriot Recruiting
Lyon, France, 69437
Contact: Hadjira Ouadfel    +33-610133675    hadjira.ouadfel@chu-lyon.fr   
Principal Investigator: Thierry Ponchon, MD         
India
Asian Institute of Gastroenterology Recruiting
Hyderabad, India, 500 082
Contact: Suresh Gundelli       suri.aigindia@gmail.com   
Principal Investigator: Nageshwar Reddy, MD         
Italy
Università Cattolica del Sacro Cuore Policlinico A. Gemelli Recruiting
Rome, Italy, 00168
Contact: Carolina Gualtieri    +39 (06) 35511515    c.gualtieri@eetc.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   
Principal Investigator: Takao Itoi, MD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Guido Costamagna, MD Catholic University of the Sacred Heart
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01774019     History of Changes
Other Study ID Numbers: CDM00047339, E7059
Study First Received: October 2, 2012
Last Updated: November 27, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hong Kong: Department of Health
India: Ministry of Health
Italy: Ministry of Health
Japan: Institutional Review Board

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

Additional relevant MeSH terms:
Carcinoma
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014