Preoperative Evaluation of the Remaining Part of the Liver for Liver Resection
Primary Purpose
Liver Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
resection
Sponsored by
About this trial
This is an interventional treatment trial for Liver Diseases
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patient under going liver resection
Arm Description
Outcomes
Primary Outcome Measures
Evaluation
Evaluation of the remaining part of the liver by CTvolumetry for further management as liver transplant
Secondary Outcome Measures
energy expenditure
Change in total energy expenditure (Kcal) following liver resection
Procedural parameters
including intraoperative blood loss
Long-term outcomes
5-year tumor recurrence rate
Perioperative liver function
including serum levels of alanine aminotransferase (ALT)
Full Information
NCT ID
NCT04100304
First Posted
September 17, 2019
Last Updated
September 20, 2019
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT04100304
Brief Title
Preoperative Evaluation of the Remaining Part of the Liver for Liver Resection
Official Title
Preoperative Evaluation of the Remaining Part of the Liver for Liver Resection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient under going liver resection
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
resection
Intervention Description
CT volumetry,liver function,biopsy before resection
Primary Outcome Measure Information:
Title
Evaluation
Description
Evaluation of the remaining part of the liver by CTvolumetry for further management as liver transplant
Time Frame
preoperative
Secondary Outcome Measure Information:
Title
energy expenditure
Description
Change in total energy expenditure (Kcal) following liver resection
Time Frame
[ Time Frame: 30 days ]
Title
Procedural parameters
Description
including intraoperative blood loss
Time Frame
intraoperative
Title
Long-term outcomes
Description
5-year tumor recurrence rate
Time Frame
5 years
Title
Perioperative liver function
Description
including serum levels of alanine aminotransferase (ALT)
Time Frame
30 days preoperative
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moaz Ahmed, master
Phone
01097179297
Email
moathahmad294@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Salah Ibrahim, professor
Phone
01061616104
Email
salah.ibrahim@med.au.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31521373
Citation
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.
Results Reference
background
PubMed Identifier
31519626
Citation
Horiuchi 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.
Results Reference
background
PubMed Identifier
31518491
Citation
Rotellar 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.
Results Reference
background
PubMed Identifier
31520695
Citation
Huiskens 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.
Results Reference
background
Learn more about this trial
Preoperative Evaluation of the Remaining Part of the Liver for Liver Resection
We'll reach out to this number within 24 hrs