Liver NeoplasmsNCT06271109
Short Term Surgical Outcomes of Anatomical Versus Non Anatomical Laparoscopic Liver Resection for Liver Tumors
An observational study of Liver Neoplasms, run by Sohag University at 1 site in Egypt.
Trial summary
aimed to discuss the short term surgical outcomes of Anatomical versus Non anatomical laparoscopic Liver resection for Liver tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Anatomical laparoscopic liver resection for liver neoplasms and Non-Anatomical laparoscopic liver resection for liver neoplasms
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Jun 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patient with liver neoplasms candidate for resection and fit for surgery
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
aimed to discuss the short term surgical outcomes of Anatomical versus Non anatomical laparoscopic Liver resection for Liver tumors.
Read the 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
- Conditions
- Liver Neoplasms
- Being tested
- Anatomical laparoscopic liver resection for liver neoplasms, Non-Anatomical laparoscopic liver resection for liver neoplasms
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical laparoscopic liver resection for liver neoplasmsProcedure or surgery
resection of liver tumors laparoscopically based on surgical anatomical segmentation of the liver
Non-Anatomical laparoscopic liver resection for liver neoplasmsProcedure or surgery
resection of liver tumors laparoscopically not based on surgical anatomical segmentation of the liver
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic Anatomical liver resection | Not described Receives: Procedure: Anatomical laparoscopic liver resection for liver neoplasms | |
| laparoscopic Non Anatomical liver resection | Not described Receives: Procedure: Non-Anatomical laparoscopic liver resection for liver neoplasms |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete resection of the neoplasm
to ensure complete resection with free resection margins
Measured: 3.5 years
Secondary outcomes (2)
residual liver tissue
to evaluate the remnant liver tissue post neoplasm resection
Measured: 3.5 years
recurrence rate
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Dec 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Ayman Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271109
- Sponsor's protocol ID
- Soh-Med-24-01-04MD
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Surgical Outcomes of Anatomical Versus Non Anatomical Laparoscopic Liver Resection for Liver Tumors
- ClinicalTrials.gov ID
- NCT06271109
- Acronym / sponsor ID
- Soh-Med-24-01-04MD
- Conditions
- Liver Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
aimed to discuss the short term surgical outcomes of Anatomical versus Non anatomical laparoscopic Liver resection for Liver tumors.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patient with liver neoplasms candidate for resection and fit for surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomical laparoscopic liver resection for liver neoplasmsresection of liver tumors laparoscopically based on surgical anatomical segmentation of the liver | Procedure or surgery | laparoscopic Anatomical liver resection |
| Non-Anatomical laparoscopic liver resection for liver neoplasmsresection of liver tumors laparoscopically not based on surgical anatomical segmentation of the liver | Procedure or surgery | laparoscopic Non Anatomical liver resection |
Primary outcome
complete resection of the neoplasm
Time frame: 3.5 years
to ensure complete resection with free resection margins
2 secondary outcomes
residual liver tissue
Time frame: 3.5 years
recurrence rate
Time frame: 3.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
Related trials for Liver Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Neoplasms, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete resection of the neoplasm (time frame: 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.