Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm | Experimental | This group will recieve Tab Ursodeoxycholic acid 450mg twice daily from the day after donor hepatectomy till post operative day 10. |
|
| Control Arm | Active Comparator | This group will receive standard medical therapy following donor hepatectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ursodeoxycholic acid | Drug | Tablet Ursodeoxycholic acid 450mg per orally twice daily from Post operative day 1 to post operative day 10. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Regenerated liver volume on Post-operative Day 14 between two groups. |
| 14 days after operation |
| Regenerated liver volume on Post-operative Day 7 between two groups. |
| 7 days after operation |
| Percentage of Total Liver Volume Restored on Post-operative Day 7 between two groups. | The percentage of Total liver volume restored on Post operative day 7 compared to the pre-operative total liver volume, between two groups. | 7 days after operation |
| Percentage of Liver Volume restored on Post-operative Day 14 between two groups. | Percentage of liver volume restored on on Post operative day 14, compared to pre-operative total liver volume, between two groups. | 14 days after the operation |
| Absolute Liver Volume growth on Day 7 | Pre-operative remnant liver volume subtracted from regenerated liver volume on Post-operative day 7, between both groups. | 7 days after the operation |
| Absolute Liver volume growth on day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Total bilirubin | serum total bilirubin versus control group | Post-operative day 1-7, 10 and 14 |
| Direct bilirubin | serum Direct bilirubin versus control group |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nihar Rn Mohapatra, MBBS,MS, MCh | Institute of Liver and Biliary Sciences, New Delhi | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | New Delhi | 110070 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Open label randomised controlled trial with 2 groups. One group receiving Tablet Ursodeoxycholic acid and the other group not receiving standard medical therapy
Not provided
Not provided
Not provided
Not provided
| Standard Medical Treatment | Other | Standard Medical Treatment |
|
Pre-operative remnant liver volume subtracted from regenerated liver volume on Post-operative day 14, between both groups.
| 14 days after the operation |
| Regeneration Velocity on Post operative day 14, between both groups | Rate of regeneration of liver(g/day), denoted by subtracting pre-operative remnant liver volume from regenerated liver volume on post operative day 14, divided by 14. | 14 days after the operation |
| Post-operative day 1-7, 10 and 14 |
| Alanine Aminotransferase(ALT) | serum ALT versus control group | Post-operative day 1-7, 10 and 14 |
| Aspartate Aminotransferase(AST) | serum AST versus control group | Post-operative day 1-7, 10 and 14 |
| Serum Alkaline Phosphatase(SAP) | serum SAP versus control group | Post-operative day 1-7, 10 and 14 |
| Serum Gamma Glutamyl Transferase(GGT) | serum SAP versus control group | Post-operative day 1-7, 10 and 14 |
| Serum Albumin | serum Albumin versus control group | Post-operative day 1-7, 10 and 14 |
| International normalized ratio(INR) | INR versus control group | Post-operative day 1-7, 10 and 14 |
| Post hepatectomy liver failure(PHLF) | Grade of PHLF as per ISGLS criteria and 50/50 criteria | Post operative day 1-14 |
| Abdominal Drain removal | Day of abdominal drain removal | Post operative day 1-14 |
| Post-operative ascites | Volume of ascites | Post operative day 1-14 |
| Post-operative complications | Grade of post-operative complications as per Clavien-Dindo classification | Post operative day 1-14 |
| Markers of liver regeneration - Serum TNF Alpha | Serum TNF Alpha vs in Control group | Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day7 |
| Markers of liver regeneration - Serum IL6 | Serum IL6 vs in Control group | Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7 |
| Markers of liver regeneration - Serum Alpha Fetoprotein | Serum Alpha Fetoprotein vs in Control group | Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7 |
| Markers of liver regeneration - TGF Beta | TGF Beta vs in Control group | Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7 |
| Markers of liver regeneration - Hepatocyte growth factor in blood | Hepatocyte growth factor vs in Control group | Pre-op Baseline , Post-operative Day 1, Post-operative Day 3, Post-operative Day 7 |
| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
Not provided
Not provided