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Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

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.
 
ClinicalTrials.gov Identifier: NCT01774019
Recruitment Status : Recruiting
First Posted : January 23, 2013
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Pancreatic Carcinoma Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System Not Applicable

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Study Type : Interventional
Estimated Enrollment : 294 participants
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
Actual Study Start Date : February 20, 2013
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


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 :
  1. 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 ]
    Count of Serious Adverse Events


Secondary Outcome Measures :
  1. 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.

  2. Time to surgery [ Time Frame: Baseline to 4 weeks ]
    Days until subject undergoes surgery

  3. Curative Intent Surgery details pertaining to intraoperative assessment of resectability, surgical resection and reconstruction techniques. [ Time Frame: Baseline to 4 weeks ]
    Details related to Curative Intent Surgery

  4. Amount of intraoperative blood loss and number of blood transfusions, duration of surgery [ Time Frame: At time of surgery ]
    Intraoperative blood loss in ml, count of transfusions and time from start to finish of surgery

  5. Biliary obstructive symptoms assessment [ Time Frame: Baseline - 120 days ]
    Record of symptoms associated with biliary obstruction

  6. Improvement of liver function test (LFT) levels as relative to baseline [ Time Frame: Week 2 - 120 days ]
    Laboratory tests for liver function

  7. 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)

  8. 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)

  9. Number, type, reason, and timing of biliary re-interventions [ Time Frame: Baseline - 120 days ]
    Count and timing of biliary re-interventions

  10. Number of hospital and ICU admissions [ Time Frame: Procedure - 120 days ]
    Count of admissions to hospital and ICU

  11. Duration of hospital and ICU admissions [ Time Frame: Procedure - 120 days ]
    Length of stay in hospital and ICU



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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Contact: Andrea Burbage 508-683-4387 andrea.burbage@bsci.com
Contact: Talia Romano 508-683-6132 talia.romano@bsci.com

Locations
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United States, California
Standford University Medical Center Completed
Stanford, California, United States, 94305
United States, Indiana
Indiana University Medical Center Withdrawn
Indianapolis, Indiana, United States, 46202
Australia, New South Wales
Westmead Hospital Completed
Westmead, New South Wales, Australia, 2145
Belgium
ULB Erasme Hospital Recruiting
Brussels, Belgium, 1070
Contact: Mia Persoons    +32 2 555 3016    Mia.Persoons@erasme.ulb.ac.be   
Principal Investigator: Jacques Devière, MD         
Canada, Quebec
Centre hospitalier de l Université de Montréal Withdrawn
Montreal, Quebec, Canada, H2X 3J4
France
Hopital Edouard Herriot Completed
Lyon, France, 69437
Hong Kong
Queen Elizabeth Hospital Recruiting
Kowloon, Hong Kong
Contact: Bing Yee Suen       suenbingyee@surgery.cuhk.edu.hk   
Principal Investigator: Nam-Hung Chia, MD         
Prince of Wales Hospital, the Chinese University of Hong Kong Recruiting
Sha Tin, Hong Kong
Contact: Bing Yee Suen       suenbingyee@surgery.cuhk.edu.hk   
Principal Investigator: James Lau, MD         
India
Asian Institute of Gastroenterology Recruiting
Hyderabad, India, 500 082
Contact: Sana Fatima       sana.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: Ryosuke Tonozuka, MD       tonozuka1978@gmail.com   
Principal Investigator: Takao Itoi, MD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Guido Costamagna, MD Fondazione Policlinico Universitario Agostino Gemelli

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01774019    
Other Study ID Numbers: 90914721
E7059 ( Other Identifier: Boston Scientific )
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Keywords provided by Boston Scientific Corporation:
Pancreatic
Periampullary Cancer
Preoperative Biliary Drainage
Resectable
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases