Short Term Surgical Outcomes of Anatomical Versus Non Anatomical Laparoscopic Liver Resection for Liver Tumors

February 14, 2024 updated by: Amir Ayman Mohamed, Sohag University
aimed to discuss the short term surgical outcomes of Anatomical versus Non anatomical laparoscopic Liver resection for Liver tumors.

Study Overview

Detailed Description

This study aimed to be both prospective and retrospective study including the cases of laparoscopic liver resection that was done and will be done during the period from December 2021 to June 2025. This study will include cohort of patients who met the eligible criteria.

Complete history taking with special concern to the following:

  • Age, sex and life style.
  • present medical history: hepatic condition and other debilitating diseases.
  • Past medical History: blood transfusion, hepatitis, liver cirrhosis and history of hospital admission.

Complete local examination of the abdomen including:

  • Local examination of the skin overlying for any signs of infection, radiation fibrosis and or presence of sinuses
  • Percussion for presence of ascites
  • Palpation for cirrhosis or any palpable masses investigations will be carried

    1. Ultrasonography: routine abdominal US for every case.
    2. Triphasic CT scan
    3. CT volumetric study to evaluate remaining liver volume when needed.
    4. Dynamic or triphasic MRI if needed
    5. Metastatic work up (CT chest, bone scan and PET scan in selected patients).
    6. Preoperative histopathological examination when needed.
    7. routine laboratory investigations

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

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

Study Locations

      • Sohag, Egypt
        • Sohag University

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

Sampling Method

Probability Sample

Study Population

patient with liver neoplasms candidate for resection and fit for surgery

Description

Inclusion Criteria:

  • all patients diagnosed with liver tumors (benign and malignant) lesions suitable for laparoscopic liver resection (Anatomical and Non anatomical)
  • Patients with Child Pugh A and early B
  • Patients Fit for surgery as regard anesthesia
  • Patients who accept to participate in the study and sign an informed consent

Exclusion Criteria:

  • Patients with Child Pugh late B&C liver disease.
  • For Patients with hepatocellular carcinoma BCLC stage C&D (extra hepatic spread and macro vascular invasion)
  • Patients with contraindications to laparoscopic surgery and (or) unfit for surgery.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
laparoscopic Anatomical liver resection
resection of liver tumors laparoscopically based on surgical anatomical segmentation of the liver
laparoscopic Non Anatomical liver resection
resection of liver tumors laparoscopically not based on surgical anatomical segmentation of the liver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete resection of the neoplasm
Time Frame: 3.5 years
to ensure complete resection with free resection margins
3.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
residual liver tissue
Time Frame: 3.5 years
to evaluate the remnant liver tissue post neoplasm resection
3.5 years
recurrence rate
Time Frame: 3.5 years
3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this 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 (Actual)

December 1, 2021

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Estimated)

February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

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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