Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

NCT ID: NCT04553458

Last Updated: 2020-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

407 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2020-06-30

Brief Summary

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EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus \< = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.

Detailed Description

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Background:

EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus \< = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma (HCC) who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.

Methods:

This work was conducted at the departments of tropical medicine and gastroenterology, internal medicine, and general surgery. This study included patients that matched our eligibility criteria for a period of five years started from June 2015 to May 2020. The study purpose was to retrospectively analyze the clinical outcomes among patients with HCC who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment favorable outcomes. The data of the patients were extracted and retrospectively reviewed from the patients' records and the databases of both hospitals (SUH and SOI).

During the period of recruitment, 407 patients diagnosed with HCC admitted to our departments and followed-up attending outpatient clinics, Sohag University Hospitals, over a 5 years period.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Favorable outcome

Cure or stable disease

Radiofrequency ablation

Intervention Type DEVICE

Radiofrequency ablation of the tumour

Trance-arterial chemoembolization

Intervention Type DRUG

Trance-arterial chemotherapy

Liver resection

Intervention Type PROCEDURE

non-anatomical or anatomical liver resection

Combined radiofrequency ablation + percutaneous ethanol injection

Intervention Type COMBINATION_PRODUCT

combined therapy

Percutaneous ethanol injection

Intervention Type DRUG

Percutaneous ethanol injection of HCC

Unfavorable outcome

Progressive (deteriorate/Recurrence) or Death

Radiofrequency ablation

Intervention Type DEVICE

Radiofrequency ablation of the tumour

Trance-arterial chemoembolization

Intervention Type DRUG

Trance-arterial chemotherapy

Combined radiofrequency ablation + percutaneous ethanol injection

Intervention Type COMBINATION_PRODUCT

combined therapy

Percutaneous ethanol injection

Intervention Type DRUG

Percutaneous ethanol injection of HCC

Systemic chemotherapy

Intervention Type DRUG

Systemic chemotherapy

Sorafenib

Intervention Type DRUG

Sorafenib

Viscum

Intervention Type DIETARY_SUPPLEMENT

Viscum for HCC

Symptomatic treatment

Intervention Type DRUG

Symptomatic treatment

Interventions

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Radiofrequency ablation

Radiofrequency ablation of the tumour

Intervention Type DEVICE

Trance-arterial chemoembolization

Trance-arterial chemotherapy

Intervention Type DRUG

Liver resection

non-anatomical or anatomical liver resection

Intervention Type PROCEDURE

Combined radiofrequency ablation + percutaneous ethanol injection

combined therapy

Intervention Type COMBINATION_PRODUCT

Percutaneous ethanol injection

Percutaneous ethanol injection of HCC

Intervention Type DRUG

Systemic chemotherapy

Systemic chemotherapy

Intervention Type DRUG

Sorafenib

Sorafenib

Intervention Type DRUG

Viscum

Viscum for HCC

Intervention Type DIETARY_SUPPLEMENT

Symptomatic treatment

Symptomatic treatment

Intervention Type DRUG

Other Intervention Names

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transcatheter arterial chemoembolization ETHANOL MIXED NEXAVAR SUPPORTIVE

Eligibility Criteria

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Inclusion Criteria

* Adult patients
* with hepatocellular carcinoma

Exclusion Criteria

* severely-ill patients
* With other system comorbidities,
* presence of extrahepatic metastasis,
* patients who dropped from the follow-up list after treatment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Emad Ali Ahmed Ali

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emad A. Ahmed, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Other Identifiers

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22/09/2020

Identifier Type: -

Identifier Source: org_study_id

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