| CTRI Number |
CTRI/2015/01/005437 [Registered on: 21/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
27/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of Preoperative Biliary Drainage RCT
in patients with Pancreatic Carcinoma |
|
Scientific Title of Study
|
Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| E7059, Version AD, 20/Oct/2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D Nageshwar Reddy |
| Designation |
MD |
| Affiliation |
Asian Institute of Gastroenterology |
| Address |
Asian Institute of Gastroenterology
6-3-661, Somajiguda
Hyderabad,India
Asian Institute of Gastroenterology
6-3-661, Somajiguda
Hyderabad,India
500 082
Hyderabad
ANDHRA PRADESH
500 082
India |
| Phone |
914023378888 |
| Fax |
|
| Email |
aigindiainfo@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Nageshwar Reddy |
| Designation |
Principal Investigator |
| Affiliation |
Asian Institute of Gastroenterology |
| Address |
Asian Institute of Gastroenterology
6-3-661, Somajiguda
Hyderabad
India
6-3-661, Somajiguda
Hyderabad
India
Hyderabad
ANDHRA PRADESH
500 082
India |
| Phone |
|
| Fax |
|
| Email |
aigindiainfo@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Nageshwar Reddy |
| Designation |
Principal Investigator |
| Affiliation |
Asian Institute of Gastroenterology |
| Address |
Asian Institute of Gastroenterology
6-3-661, Somajiguda
Hyderabad
India
6-3-661, Somajiguda
Hyderabad – 500 082
India
Hyderabad
ANDHRA PRADESH
500 082
India |
| Phone |
|
| Fax |
|
| Email |
aigindiainfo@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Boston Scientific
100 Boston Scientific Way
Marlborough, MA 01752 |
|
|
Primary Sponsor
|
| Name |
Boston Scientific |
| Address |
100 Boston Scientific Way
Marlborough, MA
01752
USA |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
Australia
Belgium
Canada
France
India
Italy
Japan
China
United States of America |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nageshwar Reddy |
Asian Institute of Gastroenterology |
6-3-661, Somajiguda
Hyderabad, India
500 082
|
914023378888
aigindiainfo@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| AIG EC |
Approved |
| AIG EC |
Approved |
| AIG IEC |
Approved |
| Asian Institute of Gastroenterology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
K83.1 – Obstruction of bile duct (biliary stricture) |
| Patients |
Pancreatic Carcinoma Resectable, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
WallFlexâ„¢ Biliary RX Fully Covered Stent System |
Patients in this group will receive a study SEMS (self-expanding metal stent) |
| Intervention |
WallFlexâ„¢ Biliary RX Fully Covered Stent System |
Patients in this group will receive a study SEMS (self-expanding metal stent, default choice for patients who are randomized to biliary drainage with a metal stent). |
| Intervention |
WallFlexâ„¢ Biliary RX Uncovered Stent System |
A WallFlexâ„¢ Biliary RX Uncovered stent may be used at the joint discretion of the endoscopic and surgical investigators for documented reasons related to the ductal anatomy, namely stricture involving the cystic duct confluence, low cystic duct confluence, or other anatomic considerations to be specified (for patients who are randomized to biliary drainage with a metal stent). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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 μmol 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 2 cm 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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
120 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
Procedure - 120 days |
| Time to surgery |
Baseline to 4 weeks |
| Curative Intent Surgery details pertaining to intraoperative assessment of resectability, surgical resection and reconstruction techniques |
Baseline to 4 weeks |
| Amount of intraoperative blood loss and blood transfusions, duration of surgery |
At time of surgery |
| Biliary obstructive symptoms assessment |
Baseline - 120 days |
| Improvement of liver function test (LFT) levels as relative to baseline |
Week 2 - 120 days |
| 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) |
Procedure |
| 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) |
At time of surgery or prior to surgery if re-intervention is needed |
| Number, type, reason, and timing of biliary re-interventions |
Baseline - 120 days |
| Number of hospital and ICU admissions |
Procedure - 120 days |
| Duration of hospital and ICU admissions |
Procedure - 120 days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="294"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/04/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/02/2013 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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. |