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RecruitingNCT07263061Updated Dec 31, 2025

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

An observational study in Hepatobiliary Disease, Pancreas Disease and Bile Duct Diseases, sponsored by Institute of Liver and Biliary Sciences, India. Recruiting at 1 site in India. Open to participants aged 13 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by Institute of Liver and Biliary Sciences, India · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
1,000
Ages
13 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hepatobiliary Disease
  • Pancreas Disease
  • Bile Duct Diseases
03

In context

Digestive System Diseases

613 studies on the registry are indexed under Digestive System Diseases; 117 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 272 across 193 observational studies indexed under Digestive System Diseases.

Browse Digestive System Diseases studies →

Lead sponsor

Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients undergoing major Hepato pancreatico Biliary surgeries.

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

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
05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • hepatobiliary and pancreatic diseases

    Patients undergoing Major Hepato Pancreato biliary surgeries

    Other: NO TREATMENT

Interventions

  • OtherNO TREATMENT

    NO TREATMENT

06

What researchers measure

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)

    Time frame: 30 days

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)

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

    Time frame: 30 days

  2. 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

    Time frame: 30 days

  3. 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

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
  • ILBS
    New Delhi, National Capital Territory of Delhi 110070, India
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07263061
Lead sponsor
Institute of Liver and Biliary Sciences, India
Responsible party
Sponsor
First posted
Dec 4, 2025
Start date
Dec 7, 2025
Primary completion
Oct 23, 2026 (estimated)
Completion
Oct 23, 2026 (estimated)
Last update
Dec 31, 2025

Study contacts

Dr Rajagopalan G, DNB
Contact
prash1108@gmail.com
8220408324
Dr Ragini Kilambi, MCh
study director · ILBS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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