Preoperative Evaluation of the Remaining Part of the Liver for Liver Resection

September 20, 2019 updated by: Moaz Ahmed Sayed Ahmed, Assiut University
  • Review the outcomes of the current treatments modalities.
  • Give an effective treatment .
  • Improve the outcome of these patients and decease rate of recurrence and complications.
  • An adequate future liver remnant (FLR) reduces the risk of postoperative liver failure after major hepatectomy.
  • incurs a risk of postoperative liver dysfunction and infection and there is a lack of objective evidence relating residual liver volume to these complications

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A liver resection is the surgical removal of all or a portion of the liver. It is also referred to as a hepatectomy, full or partial. A complete liver resection is performed in the setting of a transplant a diseased liver is removed from a deceased donor (cadaver). A living donor may also provide a piece of liver tissue which is procured through a partial hepatectomy, The procedure may be performed through a traditional open procedure or using minimally invasive techniques.

When is Liver Resection Performed Most hepatectomies are performed for the treatment of hepatic neoplasms, both benign or malignant. Benign neoplasms include hepatocellular adenoma, hepatic hemangioma and focal nodular hyperplasia.The most common malignant neoplasms (cancers) of the liver are metastases; those arising from colorectal cancer are among the most common, and the most amenable to surgical resection. The most common primary malignant tumour of the liver is the hepatocellular carcinoma. Hepatectomy may also be the procedure of choice to treat intrahepatic gallstones or parasitic cysts of the liver.

Liver surgery is safe when performed by experienced surgeons with appropriate technological and institutional support. As with most major surgical procedures, there is a marked tendency towards optimal results at the hands of surgeons with high caseloads in selected centres (typically cancer academic medical centers and transplantation centers).

Partial hepatectomy is surgery to remove part of the liver. Only people with good liver function who are healthy enough for surgery and who have a single tumor that has not grown into blood vessels can have this operation.

Imaging tests, such as CT or MRI with angiography are done first to see if the cancer can be removed completely. Still, sometimes during surgery the cancer is found to be too large or has spread too far to be removed, and the surgery that has been planned cannot be done.

Can a portion of the remaining normal liver grow back? When a portion of a normal liver is removed, the remaining liver can grow back (regenerate) to the original size within several weeks. A cirrhotic liver, however, cannot grow back. Therefore, before resection is performed for HCC, the non-tumor portion of the liver should be biopsied to determine whether there is associated cirrhosis.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing liver resection for benign or malignant hepatic neoplasm at the time of study(two years)
  • Patient consent.
  • Age of the patient : Any age

Exclusion Criteria:

  • patients has contraindication to do liver resection surgery.
  • patients who are unfit for any surgical interventions.
  • patients who refuse the operation or refusing to share his data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: patient under going liver resection
CT volumetry,liver function,biopsy before resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation
Time Frame: preoperative
Evaluation of the remaining part of the liver by CTvolumetry for further management as liver transplant
preoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
energy expenditure
Time Frame: [ Time Frame: 30 days ]
Change in total energy expenditure (Kcal) following liver resection
[ Time Frame: 30 days ]
Procedural parameters
Time Frame: intraoperative
including intraoperative blood loss
intraoperative
Long-term outcomes
Time Frame: 5 years
5-year tumor recurrence rate
5 years
Perioperative liver function
Time Frame: 30 days preoperative
including serum levels of alanine aminotransferase (ALT)
30 days preoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

March 30, 2022

Study Completion (Anticipated)

July 30, 2022

Study Registration Dates

First Submitted

September 17, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (Actual)

September 24, 2019

Study Record Updates

Last Update Posted (Actual)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • liver resection

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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