FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
Details   
 
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.

 
Close