| CTRI Number |
CTRI/2025/09/094352 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Early versus delayed gall stone removal surgery in moderately severe and severe pancreatitis cases |
|
Scientific Title of Study
|
Early Versus Delayed Laparoscopic Cholecystectomy in Moderately Severe and Severe Acute Biliary Pancreatitis : A Randomised Controlled Trial |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priti Ranjan Rout |
| Designation |
Junior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Room No - 715, Hostel No. 18, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
8917397596 |
| Fax |
|
| Email |
pritiranjanrout123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajinder Parshad |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Room No 419, Department of Surgical Disciplines,
Surgery Block
All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9868397715 |
| Fax |
|
| Email |
rajinderparshad@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajinder Parshad |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Room No. 419, Surgery block, Department of Surgical Disciplines, New Delhi
South
DELHI
110029
India |
| Phone |
9868397715 |
| Fax |
|
| Email |
rajinderparshad@aiims.edu |
|
|
Source of Monetary or Material Support
|
| AIIMS NEW DELHI, Ansari Nagar, South Delhi, PIN 110029 |
|
|
Primary Sponsor
|
| Name |
Priti Ranjan Rout |
| Address |
AIIMS NEW DELHI, Ansari Nagar, South Delhi, Delhi, 110029 |
| 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 |
| Priti Ranjan Rout |
AIIMS NEW DELHI |
ANSARI NAGAR, South Delhi, 110029
South
DELHI |
8917397596
pritiranjanrout123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, AIIMS NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K851||Biliary acute pancreatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Delayed Cholecystectomy |
Cholecystectomy after 6 to 8 weeks of resolution of Severe and Modertaely Severe Acute Pancreatitis episode |
| Intervention |
Early Cholecystectomy |
Early Laparoscopic Cholecystectomy immediately after the resolution of Severe and Moderately Severe acute pancreatitis episode |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Moderately severe and Severe Acute biliary pancreatitis as per revised atlanta classification
2. Fit for surgery as per anaesthesia and absence of large collection in right upper quadrant of abdomen |
|
| ExclusionCriteria |
| Details |
1. Prior history of hepatobiliary surgery
2. ASA III or more
3. Significant comorbidity - CKD, Congestive heart failure or decompensated cirrhosis
4. Pregnancy
5. Refusal to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recurrence of Acute Pancreatitis/ new onset Acute Cholecystitis/ Cholangitis or any other pancreatico biliary event requiring invasive intervention |
from date of randomisation to 1week, 3 week and 3 months after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Minor surgical complication according to clavien dindo classification & comprehensive complication index |
Day of surgery to 1week, 3 week & 3 months postoperative period |
| Need for drainage procedure of peripancreatic fluid collection prior to surgery |
From randomisation to date of surgery |
| total operating time |
skin incision to skin closure |
| Post operative hospital stay |
From day of surgery to 3 months |
| Need for readmission or intervention |
From randomisation to 3 months |
| Difficulty of the procedure as assessed by the surgeon |
Intraoperative |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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)
|
20/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pritiranjanrout123@gmail.com].
- For how long will this data be available start date provided 15-08-2025 and end date provided 31-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The aim of the trial is to compare early ( same admission ) vs delayed ( after 6-8 weeks ) laparoscopic cholesystectomy in patients of moderately severe and severe acute biliary pancreatitis in terms of interim major pancreaticobiliary events and major surgical outcomes |