Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma

NCT03138031 | Completed

• 1 other identifier: IS-002-17
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma Non-resectable

Keywords

Percutaneuos Ethanol alcohol injection

Outcome Measures

Primary Outcomes (1)

• Overall survival rate

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

  3 years

Secondary Outcomes (3)

• Disease free survival

  3 years

• Major complications' rate

  3 years

• Tumor response rate

  3 years

Study Arms (1)

Percutaneous Ethanol Injection (PEI)

EXPERIMENTAL

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

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.

Percutaneous Ethanol Injection (PEI)

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The National Ribat University: lead

Study Sites (1)

Ribat University Hospital

Khartoum, 11111, Sudan

Location

MeSH Terms

Interventions

Ethanol; Injections

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Osama M Elsanousi, MD

  The National Ribat University

  PRINCIPAL INVESTIGATOR

• Murtada M Mohamed, MD

  Ribat University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgeon

Model Details: Single Group Assignment. Prospective and non-randomized clinical trial

Study Record Dates

• First Submitted: April 30, 2017
• First Posted: May 3, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 30, 2018
• Last Updated: May 14, 2019

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

SU (1)