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

NCT07263061 | Recruiting

• 1 other identifier: IEC/2024/110/MA04
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Disease; Bile Duct Diseases; Hepatobiliary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To correlate the time to recovery of albumin with complications and morbidity (Clavien Dindo classification, Comprehensive Complication Index, Intensive Care Unit Stay)

  30 days

• Time to reversal trend of albumin and Hospital stay

  30 days

• correlation of time to recovery of albumin and re admission rates

  90 days

Study Arms (1)

hepatobiliary and pancreatic diseases

Patients undergoing Major Hepato Pancreato biliary surgeries

Other: NO TREATMENT

Interventions

NO TREATMENT OTHER

NO TREATMENT

hepatobiliary and pancreatic diseases

Eligibility Criteria

• Age: 13 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing major Hepato pancreatico Biliary surgeries.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

ILBS

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Digestive System Diseases; Pancreatic Diseases; Bile Duct Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases

Study Officials

• Dr Ragini Kilambi, MCh

  ILBS

  STUDY DIRECTOR

Central Study Contacts

Dr Rajagopalan G, DNB

CONTACT

8220408324; prash1108@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 4, 2025
• Study Start: December 7, 2025
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-11

Locations

IN (1)