Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma

NCT ID: NCT03129685

Last Updated: 2018-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-20

Study Completion Date

2018-12-19

Brief Summary

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

Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective and non-randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Devascularization

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

Group Type EXPERIMENTAL

HALED

Intervention Type PROCEDURE

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.

Interventions

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HALED

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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 thrombocytopenia;
* Unable or unwilling to attend follow up visits and examinations;
* Other associated surgical procedure;
Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The National Ribat University

OTHER

Sponsor Role lead

Responsible Party

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Osama Mohamed Elsanousi

Associate Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osama M Elsanousi, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine. The National Ribat University

Locations

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Ribat University Hospital

Khartoum, , Sudan

Site Status RECRUITING

Countries

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Sudan

Central Contacts

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Osama M Elsanousi, MD

Role: CONTACT

+249 1222 29574

References

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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.

Reference Type DERIVED
PMID: 31265917 (View on PubMed)

Other Identifiers

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IS-001-17

Identifier Type: -

Identifier Source: org_study_id

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