NCT03138044

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

May 20, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

2.9 years

First QC Date

April 30, 2017

Last Update Submit

May 11, 2019

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaIpsilateral Liver Lobe DevascularizationAlcohol TreatmentCILDAT

Outcome Measures

Primary Outcomes (1)

  • Overall survival rate

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

    3 years

Secondary Outcomes (4)

  • Disease free survival

    3 years

  • Major complications' rate

    3 years

  • Major toxicity rate

    3 years

  • Tumor response rate

    3 years

Study Arms (1)

Combined Treatment

EXPERIMENTAL

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

Procedure: Combined Treatment

Interventions

Combined TreatmentPROCEDURE

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.

Also known as: CILDAT
Combined Treatment

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (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 uncorrectable thrombocytopenia;
  • Unable or unwilling to attend follow up visits and examinations;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ribat University Hospital

Khartoum, 11111, Sudan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34888043DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Osama M Elsanousi, MD

    The National Ribat University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Osama M Elsanousi, MD

CONTACT

+249 1222 29574osamagreen55@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, non-randomized and time series clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon

Study Record Dates

First Submitted

April 30, 2017

First Posted

May 3, 2017

Study Start

May 20, 2017

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

May 14, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

SU(1)