Liver DiseasesNCT04100304
Preoperative Evaluation of the Remaining Part of the Liver for Liver Resection
A study testing resection in people with Liver Diseases, run by Assiut University.
Trial summary
Review the outcomes of the current treatments modalities. Give an effective treatment . Improve the outcome of these patients and decease rate of recurrence and complications. An adequate future liver remnant (FLR) reduces the risk of postoperative liver failure after major hepatectomy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- What is being tested?
- resection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 30 Jul 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing liver resection for benign or malignant hepatic neoplasm at the time of study(two years)
- Patient consent.
- Age of the patient : Any age
Who cannot join
- patients has contraindication to do liver resection surgery.
- patients who are unfit for any surgical interventions.
- patients who refuse the operation or refusing to share his data.
Trial locations and contacts
No sites are listed yet.
About this study
- Review the outcomes of the current treatments modalities.
- Give an effective treatment .
- Improve the outcome of these patients and decease rate of recurrence and complications.
- An adequate future liver remnant (FLR) reduces the risk of postoperative liver failure after major hepatectomy.
- incurs a risk of postoperative liver dysfunction and infection and there is a lack of objective evidence relating residual liver volume to these complications
Read the detailed description
A liver resection is the surgical removal of all or a portion of the liver. It is also referred to as a hepatectomy, full or partial. A complete liver resection is performed in the setting of a transplant a diseased liver is removed from a deceased donor (cadaver). A living donor may also provide a piece of liver tissue which is procured through a partial hepatectomy, The procedure may be performed through a traditional open procedure or using minimally invasive techniques.
When is Liver Resection Performed Most hepatectomies are performed for the treatment of hepatic neoplasms, both benign or malignant. Benign neoplasms include hepatocellular adenoma, hepatic hemangioma and focal nodular hyperplasia.The most common malignant neoplasms (cancers) of the liver are metastases; those arising from colorectal cancer are among the most common, and the most amenable to surgical resection. The most common primary malignant tumour of the liver is the hepatocellular carcinoma. Hepatectomy may also be the procedure of choice to treat intrahepatic gallstones or parasitic cysts of the liver.
Liver surgery is safe when performed by experienced surgeons with appropriate technological and institutional support. As with most major surgical procedures, there is a marked tendency towards optimal results at the hands of surgeons with high caseloads in selected centres (typically cancer academic medical centers and transplantation centers).
Partial hepatectomy is surgery to remove part of the liver. Only people with good liver function who are healthy enough for surgery and who have a single tumor that has not grown into blood vessels can have this operation.
Imaging tests, such as CT or MRI with angiography are done first to see if the cancer can be removed completely. Still, sometimes during surgery the cancer is found to be too large or has spread too far to be removed, and the surgery that has been planned cannot be done.
Can a portion of the remaining normal liver grow back? When a portion of a normal liver is removed, the remaining liver can grow back (regenerate) to the original size within several weeks. A cirrhotic liver, however, cannot grow back. Therefore, before resection is performed for HCC, the non-tumor portion of the liver should be biopsied to determine whether there is associated cirrhosis.
- Conditions
- Liver Diseases
- Being tested
- resection
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resectionDiagnostic test
CT volumetry,liver function,biopsy before resection
| Study group | Role | What they receive |
|---|---|---|
| patient under going liver resection | Other | Not described Receives: Diagnostic Test: resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation
Evaluation of the remaining part of the liver by CTvolumetry for further management as liver transplant
Measured: preoperative
Secondary outcomes (4)
energy expenditure
Change in total energy expenditure (Kcal) following liver resection
Measured: [ Time Frame: 30 days ]
Procedural parameters
including intraoperative blood loss
Measured: intraoperative
Long-term outcomes
5-year tumor recurrence rate
Measured: 5 years
Perioperative liver function
including serum levels of alanine aminotransferase (ALT)
Measured: 30 days preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moaz Ahmed Sayed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100304
- Sponsor's protocol ID
- liver resection
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang Z, Sun H, Li K, Yao W, Dong K, Ma Y, Zheng S. Prognostic factor analysis of stage 4S neuroblastoma in infant patients: A single center study. J Pediatr Surg. 2019 Dec;54(12):2585-2588. doi: 10.1016/j.jpedsurg.2019.08.031. Epub 2019 Aug 30.
PubMed 31521373Horiuchi T, Haruki K, Shiba H, Sakamoto T, Saito N, Shirai Y, Iwase R, Fujiwara Y, Yanaga K. Assessment of Outcome of Hepatic Resection for Extremely Elderly Patients With a Hepatic Malignancy. Anticancer Res. 2019 Sep;39(9):5143-5148. doi: 10.21873/anticanres.13709.
PubMed 31519626Rotellar F, Marti-Cruchaga P, Zozaya G, Tuero C, Lujan J, Benito A, Hidalgo F, Lopez-Olaondo L, Pardo F. Standardized laparoscopic central hepatectomy based on hilar caudal view and root approach of the right hepatic vein. J Hepatobiliary Pancreat Sci. 2020 Jan;27(1):E7-E8. doi: 10.1002/jhbp.669. Epub 2019 Oct 10.
PubMed 31518491Huiskens J, Bolhuis K, Engelbrecht MR, De Jong KP, Kazemier G, Liem MS, Verhoef C, de Wilt JH, Punt CJ, van Gulik TM; Dutch Colorectal Cancer Group. Outcomes of Resectability Assessment of the Dutch Colorectal Cancer Group Liver Metastases Expert Panel. J Am Coll Surg. 2019 Dec;229(6):523-532.e2. doi: 10.1016/j.jamcollsurg.2019.08.1445. Epub 2019 Sep 11.
PubMed 31520695
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Evaluation of the Remaining Part of the Liver for Liver Resection
- ClinicalTrials.gov ID
- NCT04100304
- Acronym / sponsor ID
- liver resection
- Conditions
- Liver Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 24 Sep 2019 (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.
- Review the outcomes of the current treatments modalities.
- Give an effective treatment .
- Improve the outcome of these patients and decease rate of recurrence and complications.
- An adequate future liver remnant (FLR) reduces the risk of postoperative liver failure after major hepatectomy.
- incurs a risk of postoperative liver dysfunction and infection and there is a lack of objective evidence relating residual liver volume to these complications
Detailed description
A liver resection is the surgical removal of all or a portion of the liver. It is also referred to as a hepatectomy, full or partial. A complete liver resection is performed in the setting of a transplant a diseased liver is removed from a deceased donor (cadaver). A living donor may also provide a piece of liver tissue which is procured through a partial hepatectomy, The procedure may be performed through a traditional open procedure or using minimally invasive techniques.
When is Liver Resection Performed Most hepatectomies are performed for the treatment of hepatic neoplasms, both benign or malignant. Benign neoplasms include hepatocellular adenoma, hepatic hemangioma and focal nodular hyperplasia.The most common malignant neoplasms (cancers) of the liver are metastases; those arising from colorectal cancer are among the most common, and the most amenable to surgical resection. The most common primary malignant tumour of the liver is the hepatocellular carcinoma. Hepatectomy may also be the procedure of choice to treat intrahepatic gallstones or parasitic cysts of the liver.
Liver surgery is safe when performed by experienced surgeons with appropriate technological and institutional support. As with most major surgical procedures, there is a marked tendency towards optimal results at the hands of surgeons with high caseloads in selected centres (typically cancer academic medical centers and transplantation centers).
Partial hepatectomy is surgery to remove part of the liver. Only people with good liver function who are healthy enough for surgery and who have a single tumor that has not grown into blood vessels can have this operation.
Imaging tests, such as CT or MRI with angiography are done first to see if the cancer can be removed completely. Still, sometimes during surgery the cancer is found to be too large or has spread too far to be removed, and the surgery that has been planned cannot be done.
Can a portion of the remaining normal liver grow back? When a portion of a normal liver is removed, the remaining liver can grow back (regenerate) to the original size within several weeks. A cirrhotic liver, however, cannot grow back. Therefore, before resection is performed for HCC, the non-tumor portion of the liver should be biopsied to determine whether there is associated cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient under going liver resection | Other | Diagnostic Test: resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing liver resection for benign or malignant hepatic neoplasm at the time of study(two years)
- Patient consent.
- Age of the patient : Any age
Key exclusion criteria (3 listed)
- patients has contraindication to do liver resection surgery.
- patients who are unfit for any surgical interventions.
- patients who refuse the operation or refusing to share his data.
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 |
|---|---|---|
| resectionCT volumetry,liver function,biopsy before resection | Diagnostic test | patient under going liver resection |
Primary outcome
Evaluation
Time frame: preoperative
Evaluation of the remaining part of the liver by CTvolumetry for further management as liver transplant
4 secondary outcomes
energy expenditure
Time frame: [ Time Frame: 30 days ]
Procedural parameters
Time frame: intraoperative
Long-term outcomes
Time frame: 5 years
Perioperative liver function
Time frame: 30 days preoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Background: PubMed 31521373Wang Z, Sun H, Li K, Yao W, Dong K, Ma Y, Zheng S. Prognostic factor analysis of stage 4S neuroblastoma in infant patients: A single center study. J Pediatr Surg. 2019 Dec;54(12):2585-2588. doi: 10.1016/j.jpedsurg.2019.08.031. Epub 2019 Aug 30.
- Background: PubMed 31519626Horiuchi T, Haruki K, Shiba H, Sakamoto T, Saito N, Shirai Y, Iwase R, Fujiwara Y, Yanaga K. Assessment of Outcome of Hepatic Resection for Extremely Elderly Patients With a Hepatic Malignancy. Anticancer Res. 2019 Sep;39(9):5143-5148. doi: 10.21873/anticanres.13709.
- Background: PubMed 31518491Rotellar F, Marti-Cruchaga P, Zozaya G, Tuero C, Lujan J, Benito A, Hidalgo F, Lopez-Olaondo L, Pardo F. Standardized laparoscopic central hepatectomy based on hilar caudal view and root approach of the right hepatic vein. J Hepatobiliary Pancreat Sci. 2020 Jan;27(1):E7-E8. doi: 10.1002/jhbp.669. Epub 2019 Oct 10.
- Background: PubMed 31520695Huiskens J, Bolhuis K, Engelbrecht MR, De Jong KP, Kazemier G, Liem MS, Verhoef C, de Wilt JH, Punt CJ, van Gulik TM; Dutch Colorectal Cancer Group. Outcomes of Resectability Assessment of the Dutch Colorectal Cancer Group Liver Metastases Expert Panel. J Am Coll Surg. 2019 Dec;229(6):523-532.e2. doi: 10.1016/j.jamcollsurg.2019.08.1445. Epub 2019 Sep 11.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing resection in people with Liver Diseases, run by Assiut University.
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 3 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 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Moaz Ahmed, master (01097179297, moathahmad294@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation (time frame: preoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04100304, which also lists 4 linked publications.
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 24 Sep 2019.