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CompletedNCT03138031Updated May 14, 2019

Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma

An interventional study of Percutaneous ethanol alcohol injection in Hepatocellular Carcinoma Non-resectable, sponsored by The National Ribat University. Completed at 1 site in Sudan. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-05-14.

Sponsored by The National Ribat University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
15 Years to 80 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Hepatocellular Carcinoma Non-resectable

Keywords

  • Percutaneuos Ethanol alcohol injection
03

Who can participate

Ages eligible
15 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Percutaneous Ethanol Injection (PEI)

    Those participants receive percutaneous ethanol alcohol injection for the large and unresectable HCC. Absolute alcohol; weekly sessions; under close monitoring; maximum of 30 mls; no anaesthesia needed and a maximum pain score of "8" during the procedure. Postprocedure analgesia may be required.

    Procedure: Percutaneous ethanol alcohol injection

Interventions

  • ProcedurePercutaneous ethanol alcohol injection

    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.

05

What researchers measure

Primary outcomes

  1. Overall survival rate

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

    Time frame: 3 years

Secondary outcomes

  1. Disease free survival

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

    Time frame: 3 years

  2. Major complications' rate

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

    Time frame: 3 years

  3. Tumor response rate

    Mean percentage reduction in the sizes of the patients' tumors

    Time frame: 3 years

06

Study locations

1 site
  • Ribat University Hospital
    Khartoum, 11111, Sudan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03138031
Lead sponsor
The National Ribat University
Responsible party
Osama Mohamed Elsanousi (General Surgeon, The National Ribat University) — Principal investigator
First posted
May 3, 2017
Start date
May 1, 2017
Primary completion
May 1, 2018
Completion
May 30, 2018
Last update
May 14, 2019

Study contacts

Osama M Elsanousi, MD
principal investigator · The National Ribat University
Murtada M Mohamed, MD
principal investigator · Ribat University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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