| CTRI Number |
CTRI/2024/03/063685 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Other (Specify) [Plastic biliary stent] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of placing a stent versus no stent on complications and bile duct stone recurrence rate after clearance in those awaiting gall bladder removal operation |
|
Scientific Title of Study
|
Role of prophylactic biliary stent in reducing the recurrence of choledocholithiasis and
biliary complications after stone clearance in patients awaiting cholecystectomy - a
Multicentric randomized controlled trial (stone trial). |
| Trial Acronym |
STONE trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshal S Mandavdhare |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Gastroenterology, Ground floor, F block, Nehru Hospital, Post Graduate Institute of Medical Education and Research
Chandigarh CHANDIGARH 160012 India |
| Phone |
9592814877 |
| Fax |
|
| Email |
hmandavdhare760@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Harshal S Mandavdhare |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Gastroenterology, Ground floor, F block, Nehru Hospital, Post Graduate Institute of Medical Education and Research
Chandigarh CHANDIGARH 160012 India |
| Phone |
9592814877 |
| Fax |
|
| Email |
hmandavdhare760@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Harshal S Mandavdhare |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Gastroenterology, Ground floor, F block, Nehru Hospital, Post Graduate Institute of Medical Education and Research
Chandigarh CHANDIGARH 160012 India |
| Phone |
9592814877 |
| Fax |
|
| Email |
hmandavdhare760@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER, Chandigarh, India |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Sector 12, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nitin Jagtap |
Asian Institute of Gastroenterology |
Survey No 136, 4/5, Plot No 2/3, Mindspace Rd, P Janardhan Reddy Nagar, Gachibowli, Hyderabad Hyderabad TELANGANA |
9182859523
docnits13@gmail.com |
| Dr Amit Yelsangikar |
Aster CMI Hospital |
Room no 1, Department of Gastroenterology, Aster CMI hospital, Shankar nagar Bangalore KARNATAKA |
9742384298
amitgy@gmail.com |
| Dr Manish Manrai |
Command hospital |
Room no 1, Department of Gastroenterology, Command hospital Lucknow UTTAR PRADESH |
9910327878
manishmanrai@yahoo.com |
| Dr Harshal S Mandavdhare |
PGIMER |
Department of Gastroenterology, Ground floor, F block, Nehru Hospital, Sector 12 Chandigarh CHANDIGARH |
9592814877
hmandavdhare760@gmail.com |
| Dr Rizwan Ahmed |
Rajagiri hospital |
Room number G-33, Centre of excellence in gastrointestinal sciences, Aluva Kozhikode KERALA |
7087217776
rizwiz87@gmail.com |
| Dr Sudhir Maharshi |
SMS Medical College and Hospital |
Room number 221, Second floor, Department of Gastroenterology, Superspeciality Hospital, opposite SMS hospital, Vivekanand Marg, Jaipur, 302001 Jaipur RAJASTHAN |
8130369247
sudhir.maharshi@gmail.com |
| Dr Shridhar Sundaram |
Tata Memorial hospital |
Room no 321, Department of Digestive Diseases and Clinical Nutrition, Homi Bhabha block, Tata Memorial Hospital, Dr E Borges Road, Parel Mumbai MAHARASHTRA |
9860096846
drsridharsundaram@gmail.com |
| Dr Shubham Jain |
TNMC & Nair Charitable Hospital |
Room no 717, Department of Gastroenterology, seventh floor, OPD building, Nair hospital, Mumbai central Mumbai MAHARASHTRA |
7710915754
drshubhamjazz@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics committee for academic research projects, T.N. Medical College &BYL Nair Hospital |
Submittted/Under Review |
| Institutional Ethics Committee Asian Institute of Gastroenterology |
Approved |
| Institutional Ethics Committee Tata Memorial Hospital |
Approved |
| Institutional Ethics committee, Command Hospital, Lucknow |
Submittted/Under Review |
| Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research, Chandigarh |
Approved |
| Office of the ethics committee, SMS medical college and attached hospitals, Jaipur |
Approved |
| Rajagiri Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No plastic biliary stent |
In patients with cholelithiasis with concomitant choledocholithiasis who undergo clearance on ERCP, a prophylactic plastic biliary stent will not be placed in the common bile duct and patients will be assessed till 3 months for development of any biliary complications or recurrence of biliary stones. In case the cholecystectomy is delayed beyond 3 months, then patients will be assessed every month for these events till they undergo cholecystectomy |
| Intervention |
Plastic biliary stent |
In patients with cholelithiasis with concomitant choledocholithiasis who undergo clearance on ERCP, a prophylactic plastic biliary stent will be placed in the common bile duct till 3 months and replaced if cholecystectomy is delayed beyond 3 months. We will study the occurrence of biliary complications and recurrence of biliary stones during this period. In case the cholecystectomy is delayed beyond 3 months, then patients will be assessed every month for these events till they undergo cholecystectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Cases of cholelithiasis with concomitant choledocholithiasis in whom CBD clearance is achieved will be included |
|
| ExclusionCriteria |
|
|
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 compare the biliary and pancreatic complications in the form of cholangitis, cholecystitis, biliary pancreatitis and post ERC pancreatitis between the stent and the no stent groups |
From ERC and clearance of stone in ERC till the time period of 3 months irrespective of the timing of cholecystectomy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- To compare the CDL recurrence rate between the stent and the no stent groups
-To compare the need for repeat ERC between the stent and the no stent groups |
From ERC and clearance of stone in ERC till the time period of 3 months irrespective of the timing of |
|
|
Target Sample Size
|
Total Sample Size="500" Sample Size from India="500"
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)
|
20/03/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients with cholelithiasis can have presence of concomitant choledocholithiasis (CDL) in upto 30%. These stones may remain asymptomatic or cause obstructive jaundice and complications like cholangitis and pancreatitis. In situations where there is a failure of CDL clearance during endoscopic retrograde cholangiography (ERC), biliary stenting is recommended to prevent complications. However, the role of prophylactic biliary stenting in situations where CDL clearance has been achieved, and the patient is awaiting cholecystectomy is debatable. One retrospective study showed benefit while a small prospective study and a retrospective study did not show benefit of prophylactic biliary stenting. We conducted a pilot randomized trial to study the role of prophylactic biliary stent in reducing CDl recurrence and biliary/pancreatic complications. In our trial the CDL recurrence rate was similar between the stent and no stent group. However, the total complication rate was significantly higher in the stent group (p-0.024). Three patients developed post ERC pancreatitis and 2 developed cholecystitis. Although, the findings of our trial were significant, however, the trial had several limitations. Amongst them important limitations were that it was single centre and the sample size of inadequate. Also, we realized that the primary outcome should be the development of complications as it is more clinically relevant in real world scenario. While asymptomatic recurrence of CDL during the follow up is just a silent event. Hence, to address the above limitations, we planned this multicenter randomized controlled trial to study the role of a prophylactic biliary stent in prevention of biliary and pancreatic complications and recurrence of stones in patients awaiting cholecystectomy after biliary stone clearance. |