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Completed

NCT Number: NCT02990351

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Tumor progression on the waiting list
  • Vascular invasion by imaging studies
  • Extrahepatic or lymph node metastasis

Treatment and study plan

loco regional therapies for HCC

Procedure

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 outcomes

  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 outcomes

  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

    • presence of viable tumour tissue in the explant pathology,
    • mictro vascular invasion
    • capsular or lymph node invasion the degree of accuracy between the last CT/ MRI and the pathology of explant

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Loco-regional Treatment for HCC Patients

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 13, 2016
Registry last updated
Dec 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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