TerminatedNot Applicable

Study of Mediators of Post Hepatectomy Liver Regeneration

Stopped: Reagants to test mediators couldnot be procured

India10 participantsStarted 2013-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * adult (18 year or more) * hepatectomy for malignant neoplasm (study group) * other GI resections for malignant G I tract tumors * willing to participate Exclusion Criteria: * less than 18 years in age * not willing to participate * immunosuppression * chronic hepatitis * cirrhosis * portal hypertension * pregenancy * oral contraceptives

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serum level (in picogram/ml) of IL-1, IL-6, TNF alfa, TNF beta,HGF, GH, Insulin, Glucagon

Timeframe: Before surgery and day 1, 3,7,14,42 and 180 after surgery

Trial details

NCT IDNCT02077062

SponsorGovind Ballabh Pant Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2021-07

View on ClinicalTrials.gov More Mediators of Post Hepatectomy Liver Regeneration trials