Hepatobiliary DiseaseNCT07263061
Time to Post-operative Recovery of Serum Albumin as a Predictor of Outcome in Major Hepato Pancreato Biliary Surgeries
An observational study of Hepatobiliary Disease and Pancreas Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 80 years
- Conditions the study is for
- Hepatobiliary Disease, Pancreas Disease, Bile Duct Diseases
- What is being tested?
- NO TREATMENT
- How many people
- 1,000 participants
- Where
- 1 siteIndia
- Study dates
- 7 Dec 2025to 23 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients undergoing major Hepato pancreatico Biliary surgeries.
Who may be able to join
- All patients undergoing major Hepato pancreatico Biliary surgeries.
- Patients who are more than 12 years of age
- Retrospective arm - Data from 2010
Who cannot join
- Patients who refuse or are unable to give consent.
- Patients with Nephrotic syndrome, Protein losing enteropathies, Inflammatory bowel
- Disease, Chronic Liver Disease.
- Emergency Surgeries
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
ILBS
New Delhi, National Capital Territory of Delhi, 110070
Dr. Rajagopalan G, DNB, 8220408324, prash1108@gmail.com
About this study
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.
- Conditions
- Hepatobiliary Disease, Pancreas Disease, Bile Duct Diseases
- Being tested
- NO TREATMENT
- Medical subject headings
- Digestive System Diseases, Pancreatic Diseases, Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO TREATMENTOther
NO TREATMENT
| Study group | Role | What they receive |
|---|---|---|
| hepatobiliary and pancreatic diseases | Patients undergoing Major Hepato Pancreato biliary surgeries Receives: Other: NO TREATMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days
Secondary outcomes (3)
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)
Measured: 30 days
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
Measured: 30 days
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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start7 Dec 2025
- Primary completion23 Oct 2026 (estimated)
- Study completion23 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatobiliary DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Ragini Kilambi, MCh, Study director, ILBS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263061
- Sponsor's protocol ID
- IEC/2024/110/MA04
- Status last verified
- Nov 2025
- First submitted
- 22 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Post-operative Recovery of Serum Albumin as a Predictor of Outcome in Major Hepato Pancreato Biliary Surgeries
- ClinicalTrials.gov ID
- NCT07263061
- Acronym / sponsor ID
- IEC/2024/110/MA04
- Conditions
- Hepatobiliary Disease, Pancreas Disease, Bile Duct Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 7 Dec 2025 (actual)
- Primary completion
- 23 Oct 2026 (estimated)
- Study completion
- 23 Oct 2026 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hepatobiliary and pancreatic diseases | – | Other: NO TREATMENTPatients undergoing Major Hepato Pancreato biliary surgeries |
Who may qualify
- Ages
- 13 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing major Hepato pancreatico Biliary surgeries.
Key inclusion criteria (3 listed)
- All patients undergoing major Hepato pancreatico Biliary surgeries.
- Patients who are more than 12 years of age
- Retrospective arm - Data from 2010
Key exclusion criteria (4 listed)
- Patients who refuse or are unable to give consent.
- Patients with Nephrotic syndrome, Protein losing enteropathies, Inflammatory bowel
- Disease, Chronic Liver Disease.
- Emergency Surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO TREATMENTNO TREATMENT | Other | hepatobiliary and pancreatic diseases |
Primary outcome
Time to recovery of serum albumin as a predictor of outcome in major hepatobiliary surgeries as measured by hospital stay.
Time frame: 30 days
Time taken for unsupported albumin in Liver function test in a rising trend (g/dl)
3 secondary outcomes
To correlate the time to recovery of albumin with complications and morbidity (Clavien Dindo classification, Comprehensive Complication Index, Intensive Care Unit Stay)
Time frame: 30 days
Time to reversal trend of albumin and Hospital stay
Time frame: 30 days
correlation of time to recovery of albumin and re admission rates
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Ragini Kilambi, MCh study director
ILBS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatobiliary Disease and Pancreas Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Rajagopalan G, DNB (8220408324, prash1108@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recovery of serum albumin as a predictor of outcome in major hepatobiliary surgeries as measured by hospital stay. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.