| CTRI Number |
CTRI/2025/11/096819 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Surgery Timing on Outcomes after Gallbladder Removal in Patients with Bile Duct Stones |
|
Scientific Title of Study
|
Evaluation of the effect of the timing of interval laparoscopic cholecystectomy on intra-operative and post-operative outcomes of patients with choledocholithiasis. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prabakaran v |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institue Of Higher Education and Research |
| Address |
Dept. of Surgery,4th floor,
SMSC Building,AVBRH Campus,
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8762011080 |
| Fax |
|
| Email |
prabakaranmbbs90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Swati Deshpande |
| Designation |
Associate Professor |
| Affiliation |
JawaharLal Nehru Medical College DMIHER |
| Address |
Dept. of General Surgery
JNMC
Wardha
MAHARASHTRA
442001
India |
| Phone |
9969274572 |
| Fax |
|
| Email |
dswat86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Deshpande |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institue Of Higher Education and Research |
| Address |
Dept. of Surgery,4th floor,
SMSC Building,AVBRH Campus,
Sawangi Meghe
MAHARASHTRA
442001
India |
| Phone |
9969274572 |
| Fax |
|
| Email |
dswat86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institue Of Higher Education and Research, Sawangi Meghe, Wardha, India, 442002 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institue Of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, India
442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Prabakaran V |
Acharya Vinoba Bhave Rural Hospital |
Dept. of General Surgery,
SMSC building ,4th floor,
Sawangi
Wardha
MAHARASHTRA |
8762011080
prabakaranmbbs90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, DMIHER(DU) |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Observational trial |
| Intervention |
NIL |
Observational trial |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All individuals between 18 to more than 65 years of age with choledocholithiasis and cholelithiasis diagnosed on the basis of ultrasonography, CECT or MRCP
All individuals undergoing interval cholecystectomy after ERCP stenting.
All individuals who come under ASA grade 1 and 2.
All individuals with choledocholithiasis with or without cholelithiasis with or without cholangitis who underwent ERCP stenting, cholecystectomy and stent removal.
All individuals who are consenting for study.
|
|
| ExclusionCriteria |
| Details |
All individuals who lost to follow up.
Failure of CBD stone clearance during ERCP.
Malignancy or primary sclerosing cholangitis.
Patients with Severe liver or kidney dysfunction
Patients who underwent previous upper abdominal surgeries.
Patients who are unfit for general anaesthesia
Patients who underwent cholecystectomy before ERCP
Patients who have Mirizzi syndrome
All individuals who are not consenting.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help to determine optimal timing between ERCP stenting and interval cholecystectomy in order to improve the intra-operative and post operative outcomes and to reduce the risk of recurrent biliary events. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
12/11/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The common bile duct (CBD) and gallbladder stones are found together in
10-18% of individuals . Among these, 50% to 55% are symptomatic, and
approximately 25% experience complications of choledocholithiasis, with
pancreatitis and cholangitis representing the most severe manifestations.
The primary approach to treating the combination of gall bladder and common
bile duct stones consists of removing CBD stones and performing
cholecystectomy. To evaluate the effect of the timing of interval laparoscopic cholecystectomy on
intra-operative and post-operative outcomes of patients with
choledocholithiasis. |