15 vs 45 Minute Pringle Maneuver in Liver Cancer Resection: Randomized Noninferiority Trial

November 14, 2025 updated by: Medical University of Warsaw

A Prospective, Randomized Noninferiority Trial Comparing 15- and 45-minute Pringle Maneuvers During Liver Resection for Oncologic Indications.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants who meet the inclusion criteria and provide written informed consent will be randomly assigned, using block randomization with a block size of 10, to one of two study groups. In Group 1, Pringle maneuvers lasting 15 minutes with a 10-minute reperfusion interval will be applied during liver resection. In Group 2, Pringle maneuvers lasting 45 minutes with a 15-minute reperfusion interval will be used. In both groups, the Pringle maneuver will be repeated as needed until completion of liver parenchymal transection. If transection is completed earlier, the maneuver will be discontinued before the randomized time. The operating surgeon and anesthesiologist may also decide to start or interrupt the Pringle maneuver outside the predefined time frames if intraoperative conditions require it.

During each Pringle maneuver, the patient's status will be monitored according to standard practice for liver resection, including blood pressure measurement, urine output, and arterial blood gas analysis. The number and duration of Pringle maneuvers, arterial blood pressure values, the type and doses of vasopressors used, serum lactate levels, the duration of parenchymal transection, total operative time, intraoperative blood loss, and hourly urine output will be recorded in perioperative case report forms.

In the postoperative period, laboratory tests will be performed on postoperative days 0, 1, 3, and 5. The occurrence of postoperative complications up to the time of hospital discharge will be documented in the patient's electronic medical record. Outcomes will be assessed by in-person outpatient visits or telemedicine consultations at approximately 6 months, 1 year, and 3 years after surgery.

The sample size was calculated using the Wald method. Based on an analysis of archival data from the Department of Transplantation and Liver Surgery, the incidence of post-hepatectomy liver failure according to the ISGLS definition is approximately 4%. Assuming 80% power, a one-sided significance level of 0.05, and a noninferiority margin of 5%, 300 participants will be enrolled in each arm.

Collected study data will be analyzed with particular attention to the duration of the Pringle maneuver, the extent and technical complexity of the resection, the primary diagnosis, and the presence of coexisting liver disease, in order to determine their influence on the study endpoints.

An interim analysis is planned after recruitment of 50% of the target sample size. If the interim analysis demonstrates a negative effect of the intervention on postoperative complications, further enrollment will be discontinued.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Warsaw, Poland, 02-091
        • Department of General, Transplant and Liver Surgery, Medical University of Warsaw
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emilia Kruk, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of a primary or secondary malignant liver tumor.
  • Age > 18 years.
  • Patient deemed eligible for liver resection.
  • WHO performance status ≤ 2.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Liver cirrhosis.
  • Liver dysfunction classified as Child-Pugh class B or C.
  • Repeat hepatectomy.
  • Prior ablation or chemoembolization of hepatic lesions.
  • Prior portal vein branch embolization.
  • Planned or performed ALPPS procedure.
  • Concomitant resection of any organ other than the gallbladder during the same operation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 15 minute Pringle manouver with 10 minute reperfusion
Hepatic pedicle clamping for 15 minutes, followed by a 10-minute declamping period during liver transection.
Procedure: Pringle manouver
The Pringle maneuver involves temporary clamping of the hepatic pedicle during liver resection to reduce blood loss during parenchymal transection.
Experimental: 45 minute Pringle manouver with 15 minute reperfusion
Hepatic pedicle clamping for 45 minutes, followed by a 15-minute declamping period during liver transection.
Procedure: Pringle manouver
The Pringle maneuver involves temporary clamping of the hepatic pedicle during liver resection to reduce blood loss during parenchymal transection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posthepatectomy liver failure
Time Frame: On or after postoperative day 5
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.
On or after postoperative day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative blood loss
Time Frame: At the completion of the surgery
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.
At the completion of the surgery
Parenchymal transection time
Time Frame: At the completion of the surgery
Time elapsed from the start of liver parenchymal transection to completion of parenchymal transection.
At the completion of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: Emilia Kruk, MD, Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/115/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share individual participant data (IPD). The design of this study does not require public IPD sharing for the reliability of the published results. De-identified IPD may be provided to journal peer reviewers under confidentiality during manuscript review.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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