Study of Mediators of Post Hepatectomy Liver Regeneration

NCT02077062 | Terminated

• 1 other identifier: gbph
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

post hepatectomy; liver regeneration; mediators

Outcome Measures

Primary Outcomes (1)

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

  change in serum level of mediators from baseline (before surgery)

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

Study Arms (2)

study (hepatectomy) group

patients undergoing hepatectomy for malignant neoplasm

control (non hepatectomy) group

patients undergoing intestinal resections (not incluiding hepatectomy) for malignant neoplasm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

liver regeneration in patient with hepatectomy

You may qualify if:

• adult (18 year or more)
• hepatectomy for malignant neoplasm (study group)
• other GI resections for malignant G I tract tumors
• willing to participate

You may not qualify if:

• less than 18 years in age
• not willing to participate
• immunosuppression
• chronic hepatitis
• cirrhosis
• portal hypertension
• pregenancy
• oral contraceptives

Sponsors & Collaborators

• Govind Ballabh Pant Hospital: lead

Study Sites (1)

G B Pant Hospital

New Delhi, National Capital Territory of Delhi, 110002, India

Location

Study Officials

• hirdaya h nag, ms

  gobind ballabh pant hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in G I Surgery

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: March 4, 2014
• Study Start: March 1, 2013
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-07

Locations

IN (1)