| CTRI Number |
CTRI/2021/09/036538 [Registered on: 15/09/2021] Trial Registered Prospectively |
| Last Modified On: |
05/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Common bile duct stenting after stone clearance in ERCP |
|
Scientific Title of Study
|
A Randomized trial to study the effect of common bile duct stent vs no stent in patients with choledocholithiasis before cholecystectomy in reducing recurrence of Common bile duct stones & biliary complications |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NK/7538/DM/225 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SASANI ARPIT DEVRAJBHAI |
| Designation |
SENIOR RESIDENT DOCTOR |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
Department of Gastroenterology Nehru Hospital
Post Graduate Institute of Medical Education and Research Chandigarh
Madhya Marg Sector 12
Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9824787741 |
| Fax |
|
| Email |
arpitsasani199@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HARSHAL MANDAVDHARE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
Department of Gastroenterology Nehru Hospital
Post Graduate Institute of Medical Education and Research Chandigarh
Madhya Marg Sector 12
Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9592814877 |
| Fax |
|
| Email |
hmandavdhare760@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SASANI ARPIT DEVRAJBHAI |
| Designation |
SENIOR RESIDENT DOCTOR |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
Department of Gastroenterology Nehru Hospital
Post Graduate Institute of Medical Education and Research Chandigarh
Madhya Marg Sector 12
Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9824787741 |
| Fax |
|
| Email |
arpitsasani199@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Department of Gastroenterology Nehru Hospital
Post Graduate Institute of Medical Education and Research Chandigarh
Madhya Marg Sector 12
Chandigarh 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| HARSHAL MANDAVDHARE |
PGIMER |
Department of Gastroenterology Ground floor F Block
Nehru Hospital
Post Graduate Institute of Medical Education and Research
Sector 12
Chandigarh 160012
Chandigarh
CHANDIGARH |
9592814877
hmandavdhare760@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CBD STENT AFTER STONE CLEARANCE |
IN PATIENTS WITH CHOLEDOCHOLITHIASIS WITH GALL BLADDER IN SITU, CBD STENT WILL BE PLACED AFTER ACHIEVING CLEARANCE OF CBD STONE ON ERCP FOR 3 MONTHS |
| Comparator Agent |
ERCP without stent placement after CBD clearance |
IN PATIENTS WITH CHOLEDOCHOLITHIASIS WITH GALL BLADDER IN SITU, CBD STENT WILL NOT BE PLACED AFTER ACHIEVING CLEARANCE OF CBD STONE ON ERCP |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Cases of choledocholithiasis with Gall Stone in whom CBD clearance achieved
Definition of CBD clearance- after achieving clearance, on occlusion cholangiogram no filling defects seen on scout film
|
|
| ExclusionCriteria |
| Details |
-Informed consent not available
-Patients opting for single stage surgery
-Previous hepatobiliary surgery
-Failure to completely clear CBDS on ERCP
-Previous cholecystectomy patients
-Associated malignancy
-Coagulopathy(INR>1.5, platlets<1lac) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the reduction on recurrence of CBD stone |
At baseline, 1 week, 4 weeks, 8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(i) Difference in biliary and pancreatic complication rates
(ii) Need for repeat ERCP during the waiting period
|
1 MONTH AND 3 MONTH POST ERCP |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gall stone disease is a leading cause for hospital
admissions related to gastrointestinal disorders. The incidence of common bile
duct stones (CBDS) has been reported in 5-18% patients undergoing
cholecystectomy for gallstones. The vast majority of CBDS arise from
gallbladder and migrate to common bile duct(CBD) following gallbladder
contraction. These stones may be asymptomatic or cause variety of problems like
obstruction and jaundice and other complication in the form of cholangitis,
pancreatitis rarely mirrizi syndrome and bouveret syndrme. Endoscopic
retrograde cholangiography(ERCP) with endoscopic sphincterotomy (EST) is
accepted as therapy of CBD stone. In acute situation, biliary stenting prevent
complication from cholangitis particularly after failed duct clearance. However
prophylactic CBD stent to eliminate complication can be done during ERCP. One
prospective study that compared EST and CBD clearance without stenting vs CBD
stenting did not show any benefit in CBD stenting. However there are not much
randomized prospective studies and data to conclude CBD stenting is not
beneficial. So we planned this randomised controlled trial comparing CBD
stent versus no stent for recurrence of CBD stone and biliary complications after ERCP and CBD clearance |