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Efficacy of Loco-regional Treatment for Hepatocellular Carcinoma Prior to Living Donor Liver Transplantation in Egypt

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ClinicalTrials.gov Identifier: NCT02990351
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Iman Fawzy Montasser, Ain Shams University

Brief Summary:
This study aimed to analyze the outcomes of loco-regional treatment prior Living Donor Liver Transplantation in patients with HCC.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma (HCC) Living Donor Liver Transplantation Procedure: loco regional therapies for HCC

Detailed Description:
50 patients received LDLT at Ain Shams Centre for Organ Transplantation (ASCOT) over 1 year of whom data of 29 HCC patients were analyzed. Twenty patients met the Milan criteria (68.97%) & 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down staging, methods, duration of follow up, the number of the patients who were successfully down-staged before LT and their outcomes after LT were recorded.

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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Loco-regional Treatment for HCC Patients
Study Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
HCC patients
29 HCC patients who had loco regional therapies for HCC were analyzed. Twenty patients met the Milan criteria (68.97%) & 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down staging, methods, duration of follow up, the number of the patients who were successfully down-staged before LT and their outcomes after LT were recorded.
Procedure: loco regional therapies for HCC
29 HCC patients received locoregonal therapy as a bridging therapy for those who were within milan and as downstaging for those were initially beyond milan. The main LRT types used for our patients were TACE and or RFA and microwave ablation




Primary Outcome Measures :
  1. Radiological Response ( complete / partial / tumour progression)in the Radiology (CT/ MRI) before transplantation [ Time Frame: 3 months ]
    the success of loco-regional therapy for hepatocellular carcinoma in term of radiological complete or partial response in the last spiral triphasic abdominal CT and /or MRI before transpalantation


Secondary Outcome Measures :
  1. the degree of accuracy between the last CT/ MRI and the pathology of explant in term of number , size and ablation (complete necrosis ) for HCC [ Time Frame: 3 months ]
    1. presence of viable tumour tissue in the explant pathology,
    2. mictro vascular invasion
    3. capsular or lymph node invasion the degree of accuracy between the last CT/ MRI and the pathology of explant



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Egyptian patients prepared for living donor liver transplantation , at Ain Shams Centre for Organ Transplantation (ASCOT) , Cairo Egypt
Criteria

Inclusion Criteria:

  1. Adult patients 18-65 years
  2. Patients transplanted for HCC within Milan and UCSF criteria who underwent pre transplant bridge or down staging treatment for HCC

Exclusion Criteria:

  1. Tumor progression on the waiting list
  2. Vascular invasion by imaging studies
  3. Extrahepatic or lymph node metastasis
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Responsible Party: Iman Fawzy Montasser, Associate profesor of tropical medicine , Ain Shams university, Ain Shams University
ClinicalTrials.gov Identifier: NCT02990351    
Other Study ID Numbers: HCC and liver transplantation
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases