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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01759901
Enrollment
100
Registered
2013-01-03
Start date
2013-01-31
Completion date
2016-12-31
Last updated
2022-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

hepatectomy, vascular inflow occlusion

Brief summary

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.

Interventions

PROCEDUREPringle

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

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative surgical complications1 month30-day morbidity after open liver resection, which includes ascites, pleural effusion, wound infection and intra-abdominal collection

Secondary

MeasureTime frameDescription
Other post-operative complications1 monthpost-operative liver failure, post-op mortality, operative blood loss, duration of operation and hospital stay
Survival5 yearOverall and disease-free survival at 1, 3, 5-year
Recurrence rate of hepatocellular carcinoma5 yearRecurrence rate of hepatocellular carcinoma at 1,3,5 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026