Liver Transplantation and Reticuloendothelial Clearance Capacity

NCT00929032 | Completed

• 1 other identifier: NanospheresLiverEdinburgh09
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Study summary: "Liver transplantation and the reticuloendothelial clearance capacity." The purpose of this study is to evaluate the effect of liver transplantation on the immune system. This study will involve the taking of a number of observations but does not involve any treatment, which differs from normal care. Indications for transplantation are solely based on the best clinical practice, which is usually performed at the department. The study measures liver function based on the clearance of different "marker" substances by the liver. These substances are given intravenously and their clearance will be measured from bloodstream. All substances used in this study are registered in the United Kingdom for clinical applications and already used in clinical practice over years. They are safe and without any risk to harm individuals under study. Furthermore no side effects or any symptoms caused by the administration of these substances are expected. Measurements of liver function are undertaken before transplantation, 1 and 7 days following the transplant. There is no restriction from any of the patient's prescribed medication. All blood samples will be removed from the cannula (drip) and will not require repeated injections. It is hoped that this research will lead to a greater understanding of the effects of liver transplantation on the immune system.

Conditions

Hepatic Insufficiency; Liver Insufficiency

Keywords

Liver Transplantation; Immunosystem of the Liver; Marginal and Non-marginal grafts

Outcome Measures

Primary Outcomes (1)

• We want to establish the immediate particulate clearance capacity of the liver following transplantation and the pattern of recovery one week later. This is used as a surrogate for liver clearance of bacteria and bacterial products.

  7 days

Secondary Outcomes (2)

• To establish whether there is any correlation between liver cell (hepatocyte) injury and immune cell (Kupffer cell) injury after transplantation.

  7 days

• To establish the effect of liver transplantation on serum expression of acute phase protein opsonins.

  7 days

Study Arms (1)

Liver transplant recipient

Liver transplant recipient

Radiation: Nanocoll®

Interventions

Nanocoll® RADIATION

To determine reticuloendothelial system (RES) phagocytosis activity and liver phagocytic function respectively we will measure plasma clearance of 99mTc labelled micro-aggregated human albumin without any imaging studies.

Liver transplant recipient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients on the waiting list for liver transplantation will be invited to participate in the study and written informed consent will be obtained from each participant. Patients who are undergoing transplantation will be studied before operation, 24 hours after transplantation and 7 days after transplantation.

You may qualify if:

• written informed consent
• chronic liver disease
• listed for transplantation at the Scottish Liver Transplant Unit

You may not qualify if:

• pregnancy (although pregnant patients would not be listed for liver transplant)
• prisoners
• acute liver failure
• living-related liver transplantation
• multi-organ transplantation or re-transplantation
• ABO incompatible donor
• HIV-positive donor or recipient
• not given informed consent

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator
• European Society of Organ Transplantation: collaborator

Study Sites (1)

University of Edinburgh

Edinburgh, Midlothian, EH16 4TJ, United Kingdom

Location

Related Publications (2)

• Schindl MJ, Millar AM, Redhead DN, Fearon KC, Ross JA, Dejong CH, Garden OJ, Wigmore SJ. The adaptive response of the reticuloendothelial system to major liver resection in humans. Ann Surg. 2006 Apr;243(4):507-14. doi: 10.1097/01.sla.0000205826.62911.a7.

  PMID: 16552202 BACKGROUND

• Medzhitov R, Janeway C Jr. Innate immunity. N Engl J Med. 2000 Aug 3;343(5):338-44. doi: 10.1056/NEJM200008033430506. No abstract available.

  PMID: 10922424 BACKGROUND

MeSH Terms

Conditions

Hepatic Insufficiency; Margins of Excision

Interventions

technetium Tc 99m nanocolloid

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen J Wigmore, Prof, MD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 26, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 20, 2010

Record last verified: 2010-10

Locations

GB (1)