NCT06271109

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

3.5 years

First QC Date

February 5, 2024

Last Update Submit

February 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • complete resection of the neoplasm

    to ensure complete resection with free resection margins

    3.5 years

Secondary Outcomes (2)

  • residual liver tissue

    3.5 years

  • recurrence rate

    3.5 years

Study Arms (2)

laparoscopic Anatomical liver resection

Procedure: Anatomical laparoscopic liver resection for liver neoplasms

laparoscopic Non Anatomical liver resection

Procedure: Non-Anatomical laparoscopic liver resection for liver neoplasms

Interventions

resection of liver tumors laparoscopically based on surgical anatomical segmentation of the liver

laparoscopic Anatomical liver resection

resection of liver tumors laparoscopically not based on surgical anatomical segmentation of the liver

laparoscopic Non Anatomical liver resection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient with liver neoplasms candidate for resection and fit for surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 21, 2024

Study Start

December 1, 2021

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations