15 vs 45 Minute Pringle Maneuver in Liver Cancer Resection: Randomized Noninferiority Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Warsaw
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Pringle manouver
Procedure/SurgeryThe Pringle maneuver involves temporary clamping of the hepatic pedicle during liver resection to reduce blood loss during parenchymal transection.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: 15 minute Pringle manouver with 10 minute reperfusionExperimental treatment 1 intervention
Group B: 45 minute Pringle manouver with 15 minute reperfusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Posthepatectomy liver failure
Posthepatectomy liver failure defined by the International Study Group of Liver Surgery as a postoperative deterioration of the liver's synthetic, excretory, and detoxifying functions, characterized by an increased INR and concomitant hyperbilirubinemia (per local lab normals) on or after postoperative day 5.
Time frame
On or after postoperative day 5Secondary outcomes
1
Intraoperative blood loss
Intraoperative blood loss is the volume of blood lost during surgery, calculated as the total volume in the suction canister(s) minus the volume of irrigation fluid administered during the procedure.
Time frame
At the completion of the surgery2
Parenchymal transection time
Time elapsed from the start of liver parenchymal transection to completion of parenchymal transection.
Time frame
At the completion of the surgerySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: