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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07263061
Enrollment
1000
Registered
2025-12-04
Start date
2025-12-07
Completion date
2026-10-23
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Duct Diseases, Hepatobiliary Disease, Pancreas Disease

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.

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.

Interventions

OTHERNO TREATMENT

NO TREATMENT

Sponsors

Institute of Liver and Biliary Sciences, India
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
13 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
To correlate the time to recovery of albumin with complications and morbidity (Clavien Dindo classification, Comprehensive Complication Index, Intensive Care Unit Stay)30 daysMajor Complications measured by Clavien Dindo Classification (Major \>grade 3A) and Comprehensive complication index (Major More than 27)
Time to reversal trend of albumin and Hospital stay30 daysTime taken for unsupported albumin in Liver function test to reach a value of more than 3 g/dl and compared with the hospital stay
correlation of time to recovery of albumin and re admission rates90 daysTime 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

Countries

India

Contacts

Primary ContactDr Rajagopalan G, DNB
prash1108@gmail.com8220408324

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026