| CTRI Number |
CTRI/2025/09/095333 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal Observational |
| Study Design |
Other |
|
Public Title of Study
|
In patients who undergo major hepatobiliary and pancreatic surgeries the albumin increase trend is assesed and compared with post operative outcomes |
|
Scientific Title of Study
|
Time to post-operative recovery of Serum Albumin as a predictor of outcome in Major Hepato Pancreato Biliary Surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajagopalan G |
| Designation |
MCh HPB Surgery Senior Resient |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Phase 1
Department of Hepatopancreatobiliary surgery
Institute of Liver and Biliary Sciences
D1 Vasant Kunj
South
DELHI
110070
India |
| Phone |
8220408324 |
| Fax |
|
| Email |
prash1108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ragini Kilambi |
| Designation |
Associate Professor |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Phase 1
3rd Floor
Department of Hepatopancreato Biliary Surgery
Institute of Liver and Biliary Sciences
D1 Vasant Kunj
South
DELHI
110070
India |
| Phone |
7835055461 |
| Fax |
|
| Email |
ragini.kilambi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ragini Kilambi |
| Designation |
Associate Professor |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Phase 1
3rd Floor
Department of Hepatopancreato Biliary Surgery
Institute of Liver and Biliary Sciences
D1 Vasant Kunj
South
DELHI
110070
India |
| Phone |
7835055461 |
| Fax |
|
| Email |
ragini.kilambi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Liver Biliary Scineces |
| Address |
Institute of Liver and Biliary Sciences
D1 Vasant Kunj
New Delhi
India
Pin 110070
|
| Type of Sponsor |
Government 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 Rajagopalan |
Institute of Liver and Biliary Sciences |
Phase 1
Department of Hepatobiliary and Pancreatic surgery
Institute of liver and Biliary Sciences
D1 Vasant kunj
Delhi
South
DELHI |
8220408324
prash1108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ILBS |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing major Hepato pancreatico Biliary surgeries.
Patients who are more than 12 years of age
Retrospective arm - Data from 2011
|
|
| ExclusionCriteria |
| Details |
Patients who refuse or are unable to give consent.
Patients with Nephrotic syndrome, Protein losing enteropathies, Inflammatory bowel Disease, Cirrhosis
Emergency Surgeries
Data unavailable in retrospective arm
Patients who underwent Discharge against Medical advice and who had in hospital mortality. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To correlate Time to reversal trend of albumin as a predictor of outcome in major HPB surgeries as measured by hospital stay.
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate the time to recovery of albumin with hospital stay complications & morbidity (Clavien Dindo classification Comprehensive Complication Index Intensive Care Unit Stay)
Time to reversal trend of albumin & CCI
Lack of reversal of albumin trend at discharge & readmission
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
06/10/2025 |
| 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="1"
Months="0"
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
|
Hepatobiliary and Pancreatic surgery is associated with substantial risk of postoperative complications. Albumin is a negative acute phase protein. Its rapid decline may be due to degree of inflammation due to surgical procedures. The decline may due to multifactorial causes.Currently, contemporary data regarding the time to recovery of albumin, as a marker for early recovery of patient from surgical stress is sparse. Delta albumin is influenced by perioperative fluid administration and albumin supplementation. Delta albumin may not reflect the true surgical stress. Early post op albumin is a reflection of intraoperative events and not postoperative recovery or events and is unpredictable. Shorter recovery time of albumin is associated with less post op complications and hospital stay. Earlier recovery of albumin predicts lower morbidity and shorter hospital stay.
|