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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01774019




Registration number
NCT01774019
Ethics application status
Date submitted
2/10/2012
Date registered
23/01/2013
Date last updated
9/07/2020

Titles & IDs
Public title
Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
Scientific title
Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer
Secondary ID [1] 0 0
E7059
Secondary ID [2] 0 0
90914721
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

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)

No Intervention: None (No Pre-Operative Biliary Drainage) - Patients in this group will not receive pre-operative biliary drainage with a study SEMS


Treatment: Devices: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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 - Count of Serious Adverse Events
Timepoint [1] 0 0
120 days
Secondary outcome [1] 0 0
Number of adverse events - 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.
Timepoint [1] 0 0
Procedure - 120 days
Secondary outcome [2] 0 0
Time to surgery - Days until subject undergoes surgery
Timepoint [2] 0 0
Baseline to 4 weeks
Secondary outcome [3] 0 0
Curative Intent Surgery details pertaining to intraoperative assessment of resectability, surgical resection and reconstruction techniques. - Details related to Curative Intent Surgery
Timepoint [3] 0 0
Baseline to 4 weeks
Secondary outcome [4] 0 0
Amount of intraoperative blood loss and number of blood transfusions, duration of surgery - Intraoperative blood loss in ml, count of transfusions and time from start to finish of surgery
Timepoint [4] 0 0
At time of surgery
Secondary outcome [5] 0 0
Biliary obstructive symptoms assessment - Record of symptoms associated with biliary obstruction
Timepoint [5] 0 0
Baseline - 120 days
Secondary outcome [6] 0 0
Improvement of liver function test (LFT) levels as relative to baseline - Laboratory tests for liver function
Timepoint [6] 0 0
Week 2 - 120 days
Secondary outcome [7] 0 0
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)
Timepoint [7] 0 0
Procedure
Secondary outcome [8] 0 0
Stent removal success - 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)
Timepoint [8] 0 0
At time of surgery or prior to surgery if re-intervention is needed.
Secondary outcome [9] 0 0
Number, type, reason, and timing of biliary re-interventions - Count and timing of biliary re-interventions
Timepoint [9] 0 0
Baseline - 120 days
Secondary outcome [10] 0 0
Number of hospital and ICU admissions - Count of admissions to hospital and ICU
Timepoint [10] 0 0
Procedure - 120 days
Secondary outcome [11] 0 0
Duration of hospital and ICU admissions - Length of stay in hospital and ICU
Timepoint [11] 0 0
Procedure - 120 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
France
State/province [5] 0 0
Lyon
Country [6] 0 0
Hong Kong
State/province [6] 0 0
Kowloon
Country [7] 0 0
Hong Kong
State/province [7] 0 0
Sha Tin
Country [8] 0 0
India
State/province [8] 0 0
Hyderabad
Country [9] 0 0
Italy
State/province [9] 0 0
Rome
Country [10] 0 0
Japan
State/province [10] 0 0
Tokyo

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01774019
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Guido Costamagna, MD
Address 0 0
Fondazione Policlinico Universitario Agostino Gemelli
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Andrea Burbage
Address 0 0
Country 0 0
Phone 0 0
508-683-4387
Fax 0 0
Email 0 0
andrea.burbage@bsci.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01774019