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Open Liver Resection With or Without Vascular Inflow Occlusion for Hepatocellular Carcinoma: a Randomized Controlled Trial


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

Open Liver Resection With or Without Vascular Inflow Occlusion for Hepatocellular Carcinoma: a Randomized Controlled Trial


Inclusion Criteria:



- Age >18

- Child's A or B cirrhosis

Exclusion Criteria:

- Informed consent not available

- Presence of portal vein thrombosis, portal vein tumor thrombus, or previous portal
vein embolisation

- Presence of hepatic artery thrombosis, previous transarterial therapy like TACE,
lipiodol-ethanol mixture injection or transarterial internal radiation

- Anticipation of portal vein resection

- Emergency hepatectomy

- Ruptured HCC

- Adhesion or anatomical variation that preclude safe and successful application of
Pringle maneuver

- Anticipation of concomitant bowel or bile duct resection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Post-operative surgical complications

Outcome Description:

30-day morbidity after open liver resection, which includes ascites, pleural effusion, wound infection and intra-abdominal collection

Outcome Time Frame:

1 month

Safety Issue:

Yes

Principal Investigator

Kit Fai Lee, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clinical Associate Professor (honorary)

Authority:

Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:

CRE-2012.351-T

NCT ID:

NCT01759901

Start Date:

January 2013

Completion Date:

February 2015

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatectomy
  • vascular inflow occlusion
  • Carcinoma
  • Carcinoma, Hepatocellular

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