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OpenTrials
Completed

NCT Number: NCT00730743

Study on Clinical Outcome of Vascular Inflow Occlusion in Open Liver Resection

This study aims to evaluate whether applying inflow vascular occlusion in modern liver resection is associated with better clinical outcome.

Eligible patients are randomly assigned to the two surgical techniques: with or without the application of inflow vascular occlusion.

Patients outcome including liver function recovery, operative time and blood loss are compared.

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Key information

Conditions

Hepatectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Child-Pugh Class A or B

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, or transarterial internal radiation
  • When portal vein resection is anticipated
  • Emergency hepatectomy
  • Ruptured hepatocellular carcinoma
  • Rehepatectomy (repeated liver resection)
  • Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver
  • When concomitant bowel or bile duct resection is anticipated

Treatment and study plan

Intermittent Pringle maneuver

Procedure

Pringle maneuver is performed by isolation of the hepatoduodenal ligament which is then encircled and occluded with atraumatic vascular clamp. The clamp is applied for 15 minutes followed by unclamping for 5 minutes and repeated till end of liver transection. Limits of clamp cycle: 3 cycles for cirrhotic liver; 4 cycles for non-cirrhotic liver.

Primary outcomes

  1. Operative blood loss

    Time frame: From skin incision to completion of operation

  2. Operative time

    Time frame: From skin incision to completion of operation

Secondary outcomes

  1. Operative morbidity and mortality

    Time frame: From date of operation to 30-day after operation

  2. Recovery of liver function

    Time frame: From date of operation to date of discharge

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Open Liver Resection With or Without Vascular Inflow Occlusion: a Randomized Control Trial

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 8, 2008
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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