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NCT Number: NCT01759901

Effect of Vascular Inflow Occlusion in Open Liver Resection for Hepatocellular Carcinoma

Bleeding is a major problem during liver resection. Vascular inflow occlusion, also known as Pringle maneuver, has been commonly employed to reduce blood loss during liver surgery. However, Pringle maneuver might cause ischaemic insult to the remnant liver and lead to post-operative liver dysfunction.

The investigators hypothesize that liver resection without the use of vascular inflow occlusion (Pringle maneuver) is associated with lower postoperative complications rate.

The aim of this study is to evaluate whether elective open liver resection without vascular inflow occlusion (Pringle Maneuvre) would lead to a reduction of post-operative surgical complications in patient with hepatocellular carcinoma.

Eligible patients undergoing liver resection in the Prince of Wales Hospital will be recruited and randomized into 2 study arms comparing the effect of Pringle maneuver.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The 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
  • 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

Treatment and study plan

Pringle

Procedure

Vascular clamp is applied across hepatoduodenal ligament intermittently in 15 minutes on / 5 minutes off interval

Other names: Vascular inflow occlusion

Primary outcomes

  1. Post-operative surgical complications

    Time frame: 1 month

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

Secondary outcomes

  1. Other post-operative complications

    Time frame: 1 month

    post-operative liver failure, post-op mortality, operative blood loss, duration of operation and hospital stay

  2. Survival

    Time frame: 5 year

    Overall and disease-free survival at 1, 3, 5-year

  3. Recurrence rate of hepatocellular carcinoma

    Time frame: 5 year

    Recurrence rate of hepatocellular carcinoma at 1,3,5 year

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 for Hepatocellular Carcinoma: a Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 3, 2013
Registry last updated
Mar 18, 2022

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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