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

Liver Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06271109
• Other study ID #: Soh-Med-24-01-04MD
• Status: Enrolling by invitation
• Start date: December 1, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2024
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

aimed to discuss the short term surgical outcomes of Anatomical versus Non anatomical laparoscopic Liver resection for Liver tumors.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Neoplasms

Intervention

Procedure:
• Anatomical laparoscopic liver resection for liver neoplasms
resection of liver tumors laparoscopically based on surgical anatomical segmentation of the liver
• Non-Anatomical laparoscopic liver resection for liver neoplasms
resection of liver tumors laparoscopically not based on surgical anatomical segmentation of the liver

Locations

Country	Name	City	State
Egypt	Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete resection of the neoplasm	to ensure complete resection with free resection margins	3.5 years
Secondary	residual liver tissue	to evaluate the remnant liver tissue post neoplasm resection	3.5 years
Secondary	recurrence rate		3.5 years