- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06271109
Short Term Surgical Outcomes of Anatomical Versus Non Anatomical Laparoscopic Liver Resection for Liver Tumors
Study Overview
Status
Conditions
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
- Ultrasonography: routine abdominal US for every case.
- Triphasic CT scan
- CT volumetric study to evaluate remaining liver volume when needed.
- Dynamic or triphasic MRI if needed
- Metastatic work up (CT chest, bone scan and PET scan in selected patients).
- Preoperative histopathological examination when needed.
- routine laboratory investigations
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Sohag, Egypt
- Sohag University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-24-01-04MD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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