| CTRI Number |
CTRI/2012/11/003103 [Registered on: 12/11/2012] Trial Registered Retrospectively |
| Last Modified On: |
20/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of WallFlex Biliary Fully Covered metal stents to plastic stents in patients with Chronic Pancreatitis |
|
Scientific Title of Study
|
A Multi-Center, Prospective, Randomized Phase 3 Study Comparing Removable, Self-Expanding Metal Stents to Plastic Stents for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CDM00047682 Version AB |
Protocol Number |
| CDM00047682 Version AC |
Protocol Number |
| NCT01543256 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D Nageshwar Reddy MD |
| Designation |
Principal Investigator |
| Affiliation |
Asian Institute of Gastroenterology |
| Address |
Asian Institute of Gastroenterology
6-3-661, Somajiguda
Hyderabad - 500 082
India
Hyderabad
ANDHRA PRADESH
500 082
India |
| Phone |
914023378888 |
| Fax |
|
| Email |
aigindia@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
D Nageshwar Reddy MD |
| Designation |
Principal Investigator |
| Affiliation |
Asian Institute of Gastroenterology |
| Address |
Chief Gastroenterologist
Asian Institute of Gastroenterology
6-3-661, Somajiguda
Hyderabad - 500 082
India
Hyderabad
ANDHRA PRADESH
500 082
India |
| Phone |
5086834335 |
| Fax |
|
| Email |
aigindia@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Shah |
| Designation |
Clinical Research Associate |
| Affiliation |
Boston Scientific Corporation |
| Address |
25 Nirmal Park
Odhav
Near Karma Gas Agency
Ahmedabad
India 382414
Ahmadabad
GUJARAT
382414
India |
| Phone |
|
| Fax |
|
| Email |
indiacra@yahoo.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Boston Scientific |
| Address |
100 Boston Scientific Way
Marlborough, MA 01752 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
Sweden |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| D Nageshwar Reddy MD |
Asian Institue of Gastroenterology |
Asian Institute of Gastroenterology
6-3-661, Somajiguda
Hyderabad - 500 082
India
Hyderabad
ANDHRA PRADESH |
914023378888
aigindia@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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)
and K86.1 other chronic pancreatitis
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metal Stents
WallFlexâ„¢ Biliary RX Fully Covered Stent System RMV
|
Not applicable as this is an implantable device |
| Comparator Agent |
Plastic stents Per Investigator preference |
Not applicable as this is an implantable device |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Chronic pancreatitis
Stricture not previously dilated
Symptomatic bile duct stricture
Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts |
|
| ExclusionCriteria |
| Details |
Stricture within 2 cm of the upper esophageal sphincter.
Dysphagia related to motility disorder.
Non-anastomotic esophageal strictures.
Esophagocolonic strictures.
Planned adjuvant radiation therapy post esophagectomy.
Prior esophageal stent placements post esophagectomy.
Active erosive esophagitis.
Sensitivity to any components of the stent or delivery system.
Concurrent medical condition that would affect the investigator’s ability to evaluate the patient’s condition or could compromise patient safety.
Participation in a clinical trial evaluating an investigational device within 3 months prior to enrollment in this study.
Stricture length 5 cm.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stricture resolution at 24 months |
24 months following initial study treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Occurence of adverse events
Number of ERCP procedures
Ability to deploy stent
Ability to remove stent
Liver Function Test
Number of outpatient procedures
Number of hospitalizations
Duration of hospitalizations
Length of procedure
Number of devices |
24 months following initial study treatment |
|
Target Sample Size
Modification(s)
|
Total Sample Size="164"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "164"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
01/09/2013 |
| Date of Study Completion (India) |
24/06/2020 |
| Date of First Enrollment (Global) |
19/09/2012 |
| Date of Study Completion (Global) |
30/09/2020 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Ramchandani, et al. Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial. Gastroenterology 2021;161:185–195 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis as it pertains to stricture resolution rates, complication rates and number of ERCP procedures during 24 months.
Statistical testing will be performed to determine if the rate of stricture resolution for the metal stent is non-inferior to the plastic stent group. The null hypothesis is that the stricture resolution rate is non-inferior in the Metal Stent Arm versus the Plastic Stent Arm |