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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 17, 2019
    Last Updated
    September 20, 2019
    Sponsor
    Assiut University
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    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

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    Preoperative Evaluation of the Remaining Part of the Liver for Liver Resection

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