Health Trials

About this trial

The goal of this clinical trial is to evaluate the safety of two durations of the Pringle maneuver in adults undergoing elective liver resection for malignant tumors. The main questions it aims to answer are:

Is the incidence of post-hepatectomy liver failure different between 15-minute and 45-minute Pringle maneuver durations?

* Do the durations differ in operative time or intraoperative blood loss? * Researchers will compare patients randomized 1:1 to 15 minutes vs 45 minutes of Pringle clamping to see if outcomes are non-inferior between groups.

Participants will:

* Undergo standard oncologic hepatectomy with the assigned Pringle duration. * Receive routine perioperative assessments, including laboratory tests and clinical evaluations. * Attend follow-up visits at approximately 6 months, 1 year, and 3 years after surgery.

Eligibility criteria

Qualifiers

Diagnosis of a primary or secondary malignant liver tumor.

Age > 18 years.

Patient deemed eligible for liver resection.

WHO performance status ≤ 2.

Disqualifiers

Liver cirrhosis.

Liver dysfunction classified as Child-Pugh class B or C.

Repeat hepatectomy.

Prior ablation or chemoembolization of hepatic lesions.

Trial design

Treatments tested in this trial

  • Pringle manouver

Treatment groups

600 Participants
are divided into 2 treatment groups

Locations

1
Department of General, Transplant and Liver Surgery, Medical University of Warsaw02-091, Warsaw Poland

Sponsors and collaborators

Medical University of Warsaw

Lead sponsor

Source ClinicalTrials.gov