ClinicalTrials.gg
Status unknownNCT03129685NRUUpdated Jun 12, 2018

Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma

An interventional study of HALED in Hepatocellular Carcinoma, sponsored by The National Ribat University. Status unknown at 1 site in Sudan. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-06-12.

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

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.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 80 Years
Sex
All
01

Study summary

Assessment of short-term outcomes of ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma: single center non-randomized trial.

Read the detailed description

Assessment of the 30-day mortality and major complications as well as the tumor size changes of the patients undergoing ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma. This is a prospective non randomized trial carried out at the Ribat University Hospital between April 2017 to March 2018.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Hepatocellular carcinoma
  • Devascularization
03

In context

Carcinoma, Hepatocellular

3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.

This study's planned enrollment of 12 is below the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

The National Ribat University is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Review and sign ;
  • 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 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;
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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
    Devascularization

    Patients undergoing ipsilateral hepatic artery ligation with extrahepatic collaterals division (HALED)

    Procedure: HALED

Interventions

  • ProcedureHALED

    This is attained via a laparotomy involves isolation of the arterial blood supply of the tumor-containing liver lobe (the ipsilateral hepatic artery as well as the extrahepatic arterial collaterals) while preserving the feeding veins.

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What researchers measure

Primary outcomes

  1. Short term mortality rate

    Percentage of patients' postoperative deaths

    Time frame: 30 day

Secondary outcomes

  1. Short term major complications' rate

    Incidence of Clavien/Dindo grade 3 or more postoperative complications

    Time frame: 30 days

  2. Tumor response rate according to mRECIST criteria.

    Estimation of the residual percentage of viable tumor following the devascularization.

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
  • Ribat University Hospital
    Khartoum, 11111, Sudan
    Recruiting
08

References and documents

Publications

  • Elsanousi OM, Mohamed MA, Salim FH, Adam EA. Selective devascularization treatment for large hepatocellular carcinoma: Stage 2A IDEAL prospective case series. Int J Surg. 2019 Aug;68:134-141. doi: 10.1016/j.ijsu.2019.06.014. Epub 2019 Jun 29. PubMed 31265917 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: From June 2018 - December 2018

Access criteria: Free

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2017 (actual). Primary completion is estimated for Nov 2018, 17 months after the start.

Of 360 non-industry interventional studies with no phase under Carcinoma, Hepatocellular, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 76. This study's planned 17 months is below that.

Counting every sponsor, half of 384 studies reached it within 47 months; a quarter within 23 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2017
First posted
Apr 26, 2017
StartActual
May 20, 2017
Primary completionEst.
Nov 19, 2018
CompletionEst.
Dec 19, 2018
Last update
Jun 12, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03129685
Lead sponsor
The National Ribat University
Responsible party
Osama Mohamed Elsanousi (Associate Professor of Surgery, The National Ribat University) — Principal investigator
First posted
Apr 26, 2017
Start date
May 20, 2017
Primary completion
Nov 19, 2018 (estimated)
Completion
Dec 19, 2018 (estimated)
Last update
Jun 12, 2018

Study contacts

Osama M Elsanousi, MD
Contact
osamagreen55@gmail.com
+249 1222 29574
Osama M Elsanousi, MD
principal investigator · Faculty of Medicine. 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 Jun 2018. You cannot join it, but the record below documents what was studied.

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