- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07664020
Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients.
Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients : A Placebo Controlled Randomised Trial
This placebo controlled randomized control study aims to analyze the effect of UDCA supplementation on liver regeneration in Living Donor Liver Transplant (LDLT) recipients. All eligible LDLT recipients during the study period will be included in the study and randomized into two groups. One group will receive Tab UDCA starting atleast 10 days pre-operatively and continued till post-operative day 10 and the other group will receive placebo. UDCA will be given at a dose of 15mg/kg per day in two divided doses. Recipients who are not willing to participate in the study, have hypersensitivity to UDCA will be excluded from the study. Pediatrics recipients and acute liver failure recipients will also be excluded.
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 transplant till NCCT Abdomen is done and regenerated liver volumes are analyzed. The anatomic(volumetric), functional(liver function tests) and regenerative biomarkers (HGF, TNF-Alpha, IL6, TGF-Beta1) will be compared between the two groups. Evaluation of incidence of Early Allograft Dysfunction (EAD) as per Modified Olthoff criteria1 will be done between the two groups. FXR receptor concentration (hepatocytes) and TGR-5 receptor concentration (cholangiocytes) will be seen in the explant liver along with evaluation of monocyte number and function and mitochondrial and nuclear DNA.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Rajguru Siwach, MS
- Telefonnummer: 01146300000
- E-post: rajgurusiwach@gmail.com
Studer Kontakt Backup
- Navn: Dr Nihar Mohapatra, MCh
- Telefonnummer: 01146300000
- E-post: nihar0310@gmail.com
Studiesteder
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110070
- ILBS
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Ta kontakt med:
- Rajguru Siwach, MS
- Telefonnummer: 01146300000
- E-post: rajgurusiwach@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
All Adult Living Donor Liver Transplant (LDLT) Recipients in ILBS from ethical board clearance to December 2027 in the Department of HPB Surgery and Liver Transplantation, Institute of Liver and Biliary Sciences
Exclusion Criteria:
- Unwillingness to participate
- Hypersensitivity to UDCA
- Patients receiving UDCA pre-operatively within 1 month of liver transplant (PBC and patients of overlap syndrome)
- Right posterior and left laterals grafts
- Emergency Liver Transplant
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Ursodeoxycholic acid+standard medical treatment
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Standard medisinsk behandling
Tab Ursodeoxycholic acid 15mg/kg in two divided doses
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Aktiv komparator: Placebo+standard medical treatment
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Standard medisinsk behandling
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Regenerated liver volume
Tidsramme: Post-Operative Day 14
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Post-Operative Day 14
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Regeneration Liver Indices • Percentage restoration of SLV (Standard liver volume) • Regeneration index (%) : (Regenerated liver volume-GW/GW)x100 • Kinetic growth rate (volume in CC/Day)
Tidsramme: Post-Operative Day 14
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Regeneration Liver Indices is defined by-
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Post-Operative Day 14
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Liver Function test
Tidsramme: Post-Operative Day 1 to Day 7, Day 10 and Day 14
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Post-Operative Day 1 to Day 7, Day 10 and Day 14
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Change in Coagulation parameter
Tidsramme: Post-Operative Day 1 to Day 7, Day 10 and Day 14
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Post-Operative Day 1 to Day 7, Day 10 and Day 14
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Change in Serum levels of biomarkers.
Tidsramme: Post-Operative Day 0, 2, 5 and 7
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Post-Operative Day 0, 2, 5 and 7
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Daily ascitic fluid output in drain/24hr
Tidsramme: Daily till Post-Operative Day 14
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Daily till Post-Operative Day 14
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Total ascitic fluid output till POD-14
Tidsramme: Post-Operative Day 14
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Post-Operative Day 14
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Bile acid receptors expression for UDCA.
Tidsramme: Post-Operative Day 1
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{FXR receptor concentration (hepatocytes), TGR-5 receptor concentration (cholangiocytes) of the explant liver}
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Post-Operative Day 1
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Evaluation of monocyte number and function (flowcytometry)
Tidsramme: Post-Operative Day 1
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Post-Operative Day 1
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Mitochondrial and nuclear DNA (markers of Ischemia-reperfusion injury)- flowcytometry
Tidsramme: Post-Operative Day 14
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Post-Operative Day 14
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IEC/2026/126/MA01
Plan for individuelle deltakerdata (IPD)
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