Clinical trial NCT06091787: Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration on Right Lobe Donor Hepatectomy
Official title: Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration on Right Lobe Donor Hepatectomy: An Open Label Randomised Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liver Regeneration
Ursodeoxycholic Acid
Partial Liver Resection
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomised controlled trial with 2 groups. One group receiving Tablet Ursodeoxycholic acid and the other group not receiving standard medical therapy
Primary purpose: TREATMENT

Brief summary: The goal of this open label randomized trial is to understand the role of oral ursodeoxycholic acid(UDCA) supplementation in the liver regeneration (in terms of liver function and anatomical growth) following right lobe donor hepatectomy. The main question it aims to answer are:

* Does Ursodeoxycholic acid supplementation on patients undergoing donor hepatectomy improve anatomical liver regeneration after partial hepatectomy as compared to control group.
* Does ursodeoxycholic acid improve liver regeneration in terms of liver function tests and biomarkers of liver regeneration(HGF, IL6, TNF Alpha, AFP, TGF Beta) as compared to control group.

Detailed description: This open label randomized control study aims to analyze the effect of ursodeoxycholic acid supplementation on liver regeneration following a right donor hepatectomy. All eligible live donors who undergo right donor hepatectomy during the study period will be included in the study and randomized into two groups. One group will receive Tab. UDCA 450mg twice daily for 10 days and the other group will not receive Tab UDCA. Live donors who are not willing to participate in the study, have hypersensitivity to UDCA or have used Tab UDCA in the past 2 weeks, will be excluded from the study. All live donors will be screened in the pre-operative period in the outpatient department.

Pre- operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (HIS) and radiological images collected from the hospital Picture archiving and communication system(PACS). The enrolled subjects will be followed up till for a period of 14 days after the donor hepatectomy till Non contrast CT Abdomen is done and regenerated liver volumes are analyzed. The anatomic(volumetric), functional(liver function tests) and regenerative biomarkers( HGF, TNF-Alpha, IL6, AFP, TGF-Beta) will be compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* All live donors undergoing Right Donor Hepatectomy in ILBS from ethical board clearance to December 2024 in the Department of HPB Surgery and Liver Transplantation, Institute of Liver and Biliary Sciences, New Delhi

Exclusion Criteria:

* Negative consent
* Hypersensitivity to UDCA
* Past history of UDCA use in the last two weeks

Primary outcomes:
measure: Regenerated liver volume on Post-operative Day 7 between two groups.
timeFrame: 7 days after operation
measure: Regenerated liver volume on Post-operative Day 14 between two groups.
timeFrame: 14 days after operation
measure: Liver Regeneration index POD 7
timeFrame: 7 days after operation
measure: Liver Regeneration index POD 14
timeFrame: 14 days after operation
Secondary outcomes:
measure: Total bilirubin
timeFrame: Post-operative day 1-7, 10 and 14
measure: Direct bilirubin
timeFrame: Post-operative day 1-7, 10 and 14
measure: Alanine Aminotransferase(ALT)
timeFrame: Post-operative day 1-7, 10 and 14
measure: Aspartate Aminotransferase(AST)
timeFrame: Post-operative day 1-7, 10 and 14
measure: Serum Alkaline Phosphatase(SAP)
timeFrame: Post-operative day 1-7, 10 and 14
measure: Serum Gamma Glutamyl Transferase(GGT)
timeFrame: Post-operative day 1-7, 10 and 14
measure: Serum Albumin
timeFrame: Post-operative day 1-7, 10 and 14
measure: International normalized ratio(INR)
timeFrame: Post-operative day 1-7, 10 and 14
measure: Post hepatectomy liver failure(PHLF)
timeFrame: Post operative day 1-14
measure: Abdominal Drain removal
timeFrame: Post operative day 1-14
measure: Post-operative ascites
timeFrame: Post operative day 1-14
measure: Post-operative complications
timeFrame: Post operative day 1-14
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
Study officials:
References: