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Completed

NCT Number: NCT03138031

Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma

Assessment of the long-term outcome of percutaneous ethanol alcohol injection (PEI) for the large and unresectable hepatocellular carcinoma: single center non-randomized trial.

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Key information

Conditions

Hepatocellular Carcinoma Non-resectable

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ribat University Hospital

Khartoum, 11111, Sudan

About this study

Assessment of the overall (OS); one year; two years and three years' survival rates; the disease free survival (DFS) and the tumor response rate in the patients undergoing (PAT or PEI) for the large and inoperable hepatocellular carcinoma. This is a prospective non randomized trial carried out at the Ribat University Hospital between May 2017 to April 2020.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Review and sign informed consent;
  • Between 15 and 80 years of age at time of trial enrollment;
  • Documented pathological and/or radiological diagnosis of hepatocellular carcinoma;
  • Radiologically documented tumor size of > 5 centimeters;
  • Radiologically documented liver cirrhosis.

Exclusion criteria

  • American Anesthesia Association (ASA) Class IV or V and/or any
  • contraindications to general anesthesia;
  • Uncontrollable ascites;
  • Deep persistent jaundice;
  • Hepatic encephalopathy;
  • Coagulopathy;
  • Severe thrombocytopenia;
  • Unable or unwilling to attend follow up visits and examinations;
  • Other associated surgical procedure;

Treatment and study plan

Percutaneous ethanol alcohol injection

Procedure

Day-case procedure; weekly sessions; uses absolute alcohol; under close monitoring; maximum dose of 30 ml; no anesthesia needed and a maximum pain score of "8" limits the procedure. Post-procedure analgesia may be required.

Primary outcomes

  1. Overall survival rate

    Time frame: 3 years

    The percentage of HCC patients who are still alive for three years after they started PEI for HCC.

Secondary outcomes

  1. Disease free survival

    Time frame: 3 years

    Percentage of HCC patients who are alive and well (without a recurrence of their HCC) 3 years after PEI.

  2. Major complications' rate

    Time frame: 3 years

    Incidence of post-procedure Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade

  3. Tumor response rate

    Time frame: 3 years

    Mean percentage reduction in the sizes of the patients' tumors

Sponsors and collaborators

Lead sponsor

The National Ribat University

Other

Registry information

Official study title

Outcome of Percutaneous Ethanol Alcohol Injection (PEI) for the Large and Unresectable Hepatocellular Carcinoma.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 3, 2017
Registry last updated
May 14, 2019

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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