Time to Post-operative Recovery of Serum Albumin as a Pre... | NCT07263061

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

NCT07263061

Sponsor

Institute of Liver and Biliary Sciences, India

Status

Recruiting

Last Update Posted

Dec 31, 2025Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Hepatobiliary Disease
Pancreas Disease
Bile Duct Diseases

Interventions

NO TREATMENT

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 7, 2025Actual

Primary Completion Date

Oct 23, 2026Estimated

Completion Date

Oct 23, 2026Estimated

First Submitted Date

Nov 22, 2025

First Submission Date that Met QC Criteria

Dec 2, 2025

First Posted Date

Dec 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2025

Last Update Posted Date

Dec 31, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hepatobiliary and pancreatic diseases		Patients undergoing Major Hepato Pancreato biliary surgeries	Other: NO TREATMENT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NO TREATMENT	Other	NO TREATMENT	hepatobiliary and pancreatic diseases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	30 days

Secondary Outcomes

Measure	Description	Time Frame
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)	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

All patients undergoing major Hepato pancreatico Biliary surgeries.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr Rajagopalan G, DNB	Contact	8220408324		prash1108@gmail.com

Overall Officials

Name	Affiliation	Role
Dr Ragini Kilambi, MCh	ILBS	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ILBS	Recruiting	New Delhi	National Capital Territory of Delhi	110070	India

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D001649	Bile Duct Diseases

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided