Time to Post-operative Recovery of Serum Albumin as a Predictor of Outcome in Major Hepato Pancreato Biliary Surgeries

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.

Study Overview

• Status: Recruiting
• Conditions: Bile Duct Diseases; Pancreas Disease; Hepatobiliary Disease
• Intervention / Treatment: Other: NO TREATMENT

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Dr Rajagopalan G, DNB; Phone Number: 8220408324; Email: prash1108@gmail.com

Study Locations

• India
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110070
      • Recruiting
      • ILBS
      • Contact: Dr. Rajagopalan G, DNB; Phone Number: 8220408324; Email: prash1108@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing major Hepato pancreatico Biliary surgeries.

Description

Inclusion Criteria:

1. All patients undergoing major Hepato pancreatico Biliary surgeries.
2. Patients who are more than 12 years of age
3. Retrospective arm - Data from 2010

Exclusion Criteria:

1. Patients who refuse or are unable to give consent.
2. Patients with Nephrotic syndrome, Protein losing enteropathies, Inflammatory bowel
3. Disease, Chronic Liver Disease.
4. Emergency Surgeries

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
hepatobiliary and pancreatic diseases; Patients undergoing Major Hepato Pancreato biliary surgeries	Other: NO TREATMENT; NO TREATMENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to recovery of serum albumin as a predictor of outcome in major hepatobiliary surgeries as measured by hospital stay.	Time taken for unsupported albumin in Liver function test in a rising trend (g/dl)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To correlate the time to recovery of albumin with complications and morbidity (Clavien Dindo classification, Comprehensive Complication Index, Intensive Care Unit Stay)	Major Complications measured by Clavien Dindo Classification (Major >grade 3A) and Comprehensive complication index (Major More than 27)	30 days
Time to reversal trend of albumin and Hospital stay	Time taken for unsupported albumin in Liver function test to reach a value of more than 3 g/dl and compared with the hospital stay	30 days
correlation of time to recovery of albumin and re admission rates	Time taken for unsupported albumin in Liver function test to reach a value of more than 3 g/dl and compared with the 90 day re admission rates	90 days

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Study Director: Dr Ragini Kilambi, MCh, ILBS

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2025
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2026

Study Registration Dates

• First Submitted: November 22, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Biliary Tract Diseases; Digestive System Diseases; Pancreatic Diseases; Bile Duct Diseases
• Other Study ID Numbers: IEC/2024/110/MA04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No