How quickly blood albumin returns after major liver, pancreas, or bile-duct surgery predicts recovery

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

This study will see if the speed at which serum albumin returns after major hepato‑pancreato‑biliary surgery predicts complications and hospital stay for patients aged 12 and up.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 13 Years to 80 Years
• Sex: All
• Sponsor: Institute of Liver and Biliary Sciences, India (Academic / other)
• Locations: 1 site (New Delhi, National Capital Territory of Delhi)
• Trial ID: NCT07263061 on ClinicalTrials.gov

What this trial studies

This is an observational cohort that combines a retrospective arm (data from 2010 onward) with contemporaneous data collection at a single tertiary hepatobiliary center. Investigators will track perioperative serum albumin levels and record the time until albumin recovers toward baseline or a predefined threshold. They will compare that recovery time with post‑operative outcomes such as complications, morbidity, and length of hospital stay while accounting for factors like fluid management and albumin supplementation. The goal is to determine whether earlier albumin recovery is associated with lower complication rates and shorter admissions.

Who should consider this trial

Good fit: Ideal candidates are patients aged over 12 undergoing planned major hepato‑pancreato‑biliary (liver, pancreas, or bile duct) surgery at the enrolling center who can provide consent.

Not a fit: Patients with chronic liver disease, nephrotic syndrome, protein‑losing enteropathies, inflammatory bowel disease, those undergoing emergency surgery, or those unable/unwilling to consent are excluded and unlikely to benefit from the study findings.

Why it matters

Potential benefit: If successful, the approach could help clinicians identify patients at higher risk of complications earlier and tailor monitoring or interventions to shorten recovery and hospital stay.

How similar studies have performed: Prior observational work has linked low perioperative albumin with worse outcomes, but contemporary data specifically using the time to albumin recovery as a prognostic marker are sparse and relatively novel.

Eligibility criteria

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

Where this trial is running

New Delhi, National Capital Territory of Delhi

• Ilbs — New Delhi, National Capital Territory of Delhi, India (Recruiting)

Study contacts

• Study coordinator: Dr Rajagopalan G, DNB

Conditions Hepatobiliary Disease; Pancreas Disease; Bile Duct Diseases