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Study of Mediators of Post Hepatectomy Liver Regeneration

NCT02077062 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2021-08-06

No results posted yet for this study

Summary

Prospective non-randomized trial to study expression of mediators of post hepatectomy liver regeneration (PHLR) and compare with a non-hepatectomy group: a pilot study Background : Experimental studies using post hepatectomy animal models have been used to study the mechanism of liver regeneration. Hepatectomy for various diseases and living donor liver transplant provide a good human model to study in vivo mechanism of liver regeneration. These studies are necessary for the clinical application of the knowledge obtained by animal experiments and will guide further research to develop new modalities for the management of hepatic failure, cirrhosis and cancer.

Null hypothesis: Expression of mediators of post hepatectomy liver regeneration (PHLR) is not different between hepatectomy (study group) and non hepatectomy group (control group).

Aim: To study the mechanism of post hepatectomy liver regeneration(PHLR) and compare expression of mediators of PHLR between hepatectomy (study group) and a non-hepatectomy group (control group).

Patient and method: This prospective non randomized trail will be conducted on two group of patients- hepatectomy (Study) group and non-hepatectomy (control) group and minimum 10 consecutive adult (18 year or more) patients will be recruited in each group according to inclusion and exclusion criteria given below. Informed consent will be obtained from the patients in both the groups. Peripheral (from a forearm vein) venous blood (6 ml) will be collected a day before surgery and at different intervals after surgery (day 1, day 3,7, 2 weeks, 6 weeks and 6 months). A small branch of portal vein will be cannulated a 20 gauge intravenous catheter for measurement of portal pressure and collection of portal venous blood (6 ml) at the start (after entry inside the abdomen) and at the end (before closure of the abdomen). Patients in hepatectomy (study) group will undergo trucut (needle) biopsy from the remnant liver. Mediators of liver regeneration will be measured by standard methods in blood samples from both groups. The liver tissue from study group will also be analysed for factors related to initiation of PHLR.

Conditions

  • Mediators of Post Hepatectomy Liver Regeneration

Sponsors & Collaborators

  • Govind Ballabh Pant Hospital

    lead OTHER_GOV

Principal Investigators

  • hirdaya h nag, ms · gobind ballabh pant hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02077062 on ClinicalTrials.gov