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NCT Number: NCT07263061

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.

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Key information

Conditions

Hepatobiliary Disease Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Pancreas Disease Pancreatic Diseases

Age range

13 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ILBS

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

Location status: Recruiting

Location contact

Dr. Rajagopalan G, DNB

CONTACT

[email protected]

8220408324

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

No treatment

Other

NO TREATMENT

Primary outcomes

  1. Time to recovery of serum albumin as a predictor of outcome in major hepatobiliary surgeries as measured by hospital stay.

    Time frame: 30 days

    Time taken for unsupported albumin in Liver function test in a rising trend (g/dl)

Secondary outcomes

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

    Time frame: 30 days

    Major Complications measured by Clavien Dindo Classification (Major >grade 3A) and Comprehensive complication index (Major More than 27)

  2. Time to reversal trend of albumin and Hospital stay

    Time frame: 30 days

    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

  3. correlation of time to recovery of albumin and re admission rates

    Time frame: 90 days

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Rajagopalan G, DNB

CONTACT

[email protected]

8220408324

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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