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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has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.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

Who can participate

Ages eligible
15 Years to 80 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 thrombocytopenia;
  • Unable or unwilling to attend follow up visits and examinations;
  • Other associated surgical procedure;
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
    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.

05

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

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. 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, Sap, Icf, Csr

08

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 ↗

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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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