MedDataX Logo

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

NCT ID: NCT07263061

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-07

Study Completion Date

2026-10-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatobiliary Disease Pancreas Disease Bile Duct Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

hepatobiliary and pancreatic diseases

Patients undergoing Major Hepato Pancreato biliary surgeries

NO TREATMENT

Intervention Type OTHER

NO TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NO TREATMENT

NO TREATMENT

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dr Ragini Kilambi, MCh

Role: STUDY_DIRECTOR

ILBS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ILBS

New Delhi, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

India

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dr Rajagopalan G, DNB

Role: CONTACT

Phone: 8220408324

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dr. Rajagopalan G, DNB

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IEC/2024/110/MA04

Identifier Type: -

Identifier Source: org_study_id