CClinicalTrials.gg
Status unknownNCT03138044Updated May 14, 2019

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

An interventional study of Combined Treatment in Hepatocellular Carcinoma, sponsored by The National Ribat University. Status unknown at 1 site in Sudan. Open to participants aged 15 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-05-14.

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

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
15 Years to 75 Years
Sex
All
01

Study 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.

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 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.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Hepatocellular Carcinoma
  • Ipsilateral Liver Lobe Devascularization
  • Alcohol Treatment
  • CILDAT
03

Who can participate

Ages eligible
15 Years to 75 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 uncorrectable thrombocytopenia;
  • Unable or unwilling to attend follow up visits and examinations;
04

Study design

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

Study arms

  • Experimental
    Combined Treatment

    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

  • ProcedureCombined Treatment

    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

05

What researchers measure

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.

    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 CILDAT

    Time frame: 3 years

  2. Major complications' rate

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

    Time frame: 3 years

  3. Major toxicity rate

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

    Time frame: 3 years

  4. Tumor response rate

    Mean percentage reduction in the sizes of the patients' tumors

    Time frame: 3 years

06

Study locations

1 of 1 sites recruiting
  • Ribat University Hospital
    Khartoum, 11111, Sudan
    Recruiting
07

References and documents

Publications

  • 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. PubMed 34888043 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03138044
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 20, 2017
Primary completion
Apr 30, 2020 (estimated)
Completion
Apr 30, 2020 (estimated)
Last update
May 14, 2019

Study contacts

Osama M Elsanousi, MD
Contact
osamagreen55@gmail.com
+249 1222 29574
Osama M Elsanousi, MD
principal investigator · The National Ribat University

Oversight

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

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion