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Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment of the Large Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status

Unknown status

Phase

Not Applicable

Locations

Sudan

Study Type

Interventional

Intervention

Combined Treatment

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Ipsilateral Liver Lobe Devascularization, Alcohol Treatment, CILDAT

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 uncorrectable thrombocytopenia;
Unable or unwilling to attend follow up visits and examinations;

Sites / Locations

Ribat University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined Treatment

Arm Description

The Combined Treatment: patients undergo a surgical operation of ipsilateral liver lobe devascularization and four weeks later after the operation percutaneous alcohol injection sessions.

Outcomes

Primary Outcome Measures

Overall survival rate

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

Secondary Outcome Measures

Disease free survival

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

Major complications' rate

Incidence of post CILDAT Clavien-Dindo comlicatins grade 3b or more.

Major toxicity rate

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

Tumor response rate

Mean percentage reduction in the sizes of the patients' tumors

Full Information

NCT ID

NCT03138044

First Posted

April 30, 2017

Last Updated

May 11, 2019

Sponsor

The National Ribat University

1. Study Identification

Unique Protocol Identification Number

NCT03138044

Brief Title

Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment of the Large Hepatocellular Carcinoma

Official Title

Long Term Outcome of Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large Hepatocellular Carcinoma (HCC)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 20, 2017 (Actual)

Primary Completion Date

April 30, 2020 (Anticipated)

Study Completion Date

April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The National Ribat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Assessment of the long-term outcome of combined ipsilateral liver lobe devascularization (ILAD) and alcohol injection of the large hepatocellular carcinoma (HCC): single center non-randomized trial.

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 Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large HCC. This is a prospective non randomized trial carried out at the Ribat University Hospital between May 2017 to April 2020.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, Ipsilateral Liver Lobe Devascularization, Alcohol Treatment, CILDAT

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective, non-randomized and time series clinical trial.

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combined Treatment

Arm Type

Experimental

Arm Description

The Combined Treatment: patients undergo a surgical operation of ipsilateral liver lobe devascularization and four weeks later after the operation percutaneous alcohol injection sessions.

Intervention Type

Procedure

Intervention Name(s)

Combined Treatment

Other Intervention Name(s)

CILDAT

Intervention Description

This modality of palliative treatment includes initial surgical operation where arterial vascular supply of the tumor carrying liver lobe of the corresponding hepatic artery as well as the extrahepatic collateral arteries (EHCAs) feeding the large HCC (> 5 cms size) under general anesthesia. Four weeks after the operation the tumor is injeted (intralesionally and intravascularly) with absolute ethanol alcohol injections on regular weekly percutaneous sessions until the tumor become saturated and its vascularity rendered inactive.

Primary Outcome Measure Information:

Title

Overall survival rate

Description

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

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Disease free survival

Description

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

Time Frame

3 years

Title

Major complications' rate

Description

Incidence of post CILDAT Clavien-Dindo comlicatins grade 3b or more.

Time Frame

3 years

Title

Major toxicity rate

Description

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

Time Frame

3 years

Title

Tumor response rate

Description

Mean percentage reduction in the sizes of the patients' tumors

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 uncorrectable thrombocytopenia; Unable or unwilling to attend follow up visits and examinations;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Osama M Elsanousi, MD

Phone

+249 1222 29574

osamagreen55@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Osama M Elsanousi, MD

Organizational Affiliation

The National Ribat University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ribat University Hospital

City

Khartoum

ZIP/Postal Code

11111

Country

Sudan

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34888043

Citation

Elsanousi OM, Mohamed MA, Salim FH, Adam EA, Bedri S. Long-term outcome of novel combined surgical-injection treatment (COSIT) for large hepatocellular carcinoma: Stage 2A IDEAL prospective case series. Ann Med Surg (Lond). 2021 Nov 24;72:103098. doi: 10.1016/j.amsu.2021.103098. eCollection 2021 Dec.

Results Reference

derived

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Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment of the Large Hepatocellular Carcinoma

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