| CTRI Number |
CTRI/2023/07/055474 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
31/08/2023 |
| 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
|
Study to evaluate ideal time for cholecystectomy after moderate and severe acute pancreatitis |
|
Scientific Title of Study
|
Early versus delayed laparoscopic cholecystectomy in moderate and severe acute biliary pancreatitis: a randomised controlled trial |
| Trial Acronym |
ELCAP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Virinder Kumar Bansal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 405,Surgical Block All India Institute of Medical Sciences, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
9810348479 |
| Fax |
|
| Email |
drvkbansal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Om Prakash |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 405,Surgical Block All India Institute of Medical Sciences, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
8003991303 |
| Fax |
|
| Email |
Drprajapatiom@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Virinder Kumar Bansal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 405,Surgical Block All India Institute of Medical Sciences, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
9810348479 |
| Fax |
|
| Email |
drvkbansal@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, New Delhi |
| Address |
All India Institute of Medical Sciences New 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 |
| Dr Harshit Gupta |
All India Institute of Medical Sciences, New Delhi |
Room No.: 410, Second floor,Surgery Block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
New Delhi
DELHI |
7791858673
HARSHIT30ROCKS@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, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Delayed Group |
Laparoscopic cholecystectomy after 6– 8 weeks of discharge |
| Intervention |
Early Group |
Laparoscopic cholecystectomy same admission cholecystectomy after resolution of acute pancreatitis
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Moderately severe or severe biliary AP diagnosed as per revised Atlanta classification
2. Fit for surgery-
A) anaesthetist the patient is fit for surgery
B) Absence of large collection in right upper abdomen |
|
| ExclusionCriteria |
| Details |
1.Age < 18 years or >70 years
2.Prior history of hepatobiliary surgery
3.American Society of Anesthesiology class III or more
4.Significant co-morbidity such as chronic kidney disease (CKD-V), Decompensated
cirrhosis or congestive heart failure
6.Pregnancy
7.Refusal to give consen |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
A composite outcome of major pancreatic-biliary events from the
time of randomization to surgery or major cholecystectomy
related complications i. e.
A. By comparing the recurrence of acute pancreatitis, cholangitis,
cholecystitis or
other pancreatic-biliary events requiring any invasive intervention.
B. By comparing the major surgical complications like
conversion of laparoscopic to open procedure, hollow viscus
injury, biliary injury or vascular injury |
Time of pancreatitis to time of surgery
1 week post surgery
3 week post surgery
3 month post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Minor Surgical Complications
➢ Need for drainage procedure for peripancreatic fluid collection
➢ Total operating time
➢ Difficulty of the procedure
➢ Intra operative complications
➢ Cost of procedure
➢ Cost effectiveness
➢ Antibiotic use after surgery
➢ Patient satisfaction score
➢ Total length of hospital stay
➢ Need for readmission & interventions |
Time of pancreatitis to time of surgery
1 week post surgery
3 week post surgery
3 month post surgery |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/07/2023 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
In patients with moderately severe and severe acute biliary pancreatitis, the ideal timing of cholecystectomy which is the definitive treatment to prevent further biliary complications is not defined. Delaying cholecystectomy is associated with pancreatic- biliary complications. In this study, we wish to define the ideal timing of cholecystectomy in patients with moderate to severe acute biliary pancreatitis. |