| CTRI Number |
CTRI/2012/12/003248 [Registered on: 20/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
24/09/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Therapeutic gastrointestinal endoscopy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison of two methods for facilitating endoscopic treatment of obstructive jaundice. |
|
Scientific Title of Study
|
Randomized comparison of precut papillotomy and endosonography guided rendezvous procedure for bile duct access in patients with distal CBD obstruction and difficult CBD cannulation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1121-7913 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinay Dhir |
| Designation |
Director Clinical research and Chief of endosonography |
| Affiliation |
Institute of advanced endoscopy, Mumbai, India |
| Address |
Institute of advanced endoscopy, 5th floor Om Chambers, Kemps corner, 123 August kranti marg, Mumbai
Mumbai
MAHARASHTRA
400036
India |
| Phone |
91-22-23685577 |
| Fax |
91-22-23616755 |
| Email |
vinaydhir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinay Dhir MDDNB |
| Designation |
Director Clinical research and Chief of endosonography |
| Affiliation |
Institute of advanced endoscopy, Mumbai, India |
| Address |
Institute of advanced endoscopy, 5th floor Om Chambers, Kemps corner, 123 August kranti marg, Mumbai
Mumbai
MAHARASHTRA
400036
India |
| Phone |
91-22-23685577 |
| Fax |
91-22-23616755 |
| Email |
vinaydhir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinay Dhir |
| Designation |
Director Clinical research and Chief of endosonography |
| Affiliation |
Institute of advanced endoscopy, Mumbai, India |
| Address |
Institute of advanced endoscopy, 5th floor Om Chambers, Kemps corner, 123 August kranti marg, Mumbai
Mumbai
MAHARASHTRA
400036
India |
| Phone |
91-22-23685577 |
| Fax |
91-22-23616755 |
| Email |
vinaydhir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of advanced endoscopy, Mumbai, India |
|
|
Primary Sponsor
|
| Name |
Vinay Dhir MDDNB |
| Address |
Institute of advanced endoscopy, 5th floor Om Chambers, Kemps corner, 123 August kranti marg, Mumbai 400036 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinay Dhir |
Institute of advanced endoscopy |
Institute of advanced endoscopy, 5th floor Om Chambers, Kemps corner, 123 August kranti marg, Mumbai 400036
Mumbai
MAHARASHTRA |
91-22-23685577
91-22-23616755
vinaydhir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hospital ethics committee, Institute of advanced endoscopy, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Obstructive jaundice requiring biliary drainage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
EUS guided rendezvous technique |
Linear echoendoscope will be used to puncture the bile duct with a 19 gauze needle. A guidewire will be passed in the bile duct and across the stricture |
| Intervention |
precut papillotomy
|
precut papillotomy will be done by deroofing the papillary orifice utilizing a precut knife. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with obstructive jaundice and accessible papilla requiring biliary drainage |
|
| ExclusionCriteria |
| Details |
bleeding diathesis
duodenal obstruction
previous precut papillotomy
poor general condition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| successful biliary drainage in one session measured at the completion of the procedure |
successful biliary drainage in one session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
total procedure time
complications
hospital stay
mortality |
seven days |
|
|
Target Sample Size
|
Total Sample Size="208"
Sample Size from India="208"
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2011 |
| Date of Study Completion (India) |
30/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open label randomized controlled trial in patients with obstructive jaundice requiring biliary drainage. 208 patients who fail selective biliary cannulation with a guidwire/sphincterotome will be randomized to receive either a precut papillotomy or EUS guided rendezvous procedure. Primary outcome will be successful biliary drainage in one session. Secondary outcome measures will be total procedure time, complications, duration of hospital stay and mortality. |