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

NCT07237204 | Not Yet Recruiting

• 1 other identifier: KB/115/2025
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cancer, Adult; Metastases to Liver; Liver Malignant Tumors

Keywords

Pringle manouver; Liver malignancy; Liver resection

Outcome Measures

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.

  On or after postoperative day 5

Secondary Outcomes (2)

• Intraoperative blood loss

  At the completion of the surgery

• Parenchymal transection time

  At the completion of the surgery

Study Arms (2)

15 minute Pringle manouver with 10 minute reperfusion

EXPERIMENTAL

Hepatic pedicle clamping for 15 minutes, followed by a 10-minute declamping period during liver transection.

Procedure: Pringle manouver

45 minute Pringle manouver with 15 minute reperfusion

EXPERIMENTAL

Hepatic pedicle clamping for 45 minutes, followed by a 15-minute declamping period during liver transection.

Procedure: Pringle manouver

Interventions

Pringle manouver PROCEDURE

The Pringle maneuver involves temporary clamping of the hepatic pedicle during liver resection to reduce blood loss during parenchymal transection.

15 minute Pringle manouver with 10 minute reperfusion; 45 minute Pringle manouver with 15 minute reperfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of General, Transplant and Liver Surgery, Medical University of Warsaw

Warsaw, 02-091, Poland

Location

Related Publications (6)

• Wang HP, Hou TY, Li WF, Yong CC. Inflow control can be safely used in laparoscopic subsegmentectomy of the liver: a single-center 10-year experience. BMC Surg. 2023 Dec 6;23(1):366. doi: 10.1186/s12893-023-02282-2.

  PMID: 38057769 BACKGROUND

• van den Broek MA, Bloemen JG, Dello SA, van de Poll MC, Olde Damink SW, Dejong CH. Randomized controlled trial analyzing the effect of 15 or 30 min intermittent Pringle maneuver on hepatocellular damage during liver surgery. J Hepatol. 2011 Aug;55(2):337-45. doi: 10.1016/j.jhep.2010.11.024. Epub 2010 Dec 13.

  PMID: 21147188 BACKGROUND

• Doi S, Yasuda S, Hokuto D, Kamitani N, Matsuo Y, Sakata T, Nishiwada S, Nagai M, Nakamura K, Terai T, Kohara Y, Sho M. Impact of the Prolonged Intermittent Pringle Maneuver on Post-Hepatectomy Liver Failure: Comparison of Open and Laparoscopic Approaches. World J Surg. 2023 Dec;47(12):3328-3337. doi: 10.1007/s00268-023-07201-3. Epub 2023 Oct 3.

  PMID: 37787778 BACKGROUND

• Liu J, Wang W, Shi C, Li C, Xue F, Hu L, Wang Y, Ge R. The difference in prolonged continuous and intermittent Pringle maneuver during complex hepatectomy for hepatocellular carcinoma patients with chronic liver disease: A retrospective cohort study. Cancer Med. 2021 Dec;10(23):8507-8517. doi: 10.1002/cam4.4361. Epub 2021 Oct 18.

  PMID: 34658153 BACKGROUND

• Fagenson AM, Gleeson EM, Nabi F, Lau KN, Pitt HA. When does a Pringle Maneuver cause harm? HPB (Oxford). 2021 Apr;23(4):587-594. doi: 10.1016/j.hpb.2020.07.014. Epub 2020 Sep 12.

  PMID: 32933844 BACKGROUND

• Huang Y, Liao A, Pu X, Yang J, Lv T, Yan L, Yang J, Wu H, Jiang L. A randomized controlled trial of effect of 15- or 25-minute intermittent Pringle maneuver on hepatectomy for hepatocellular carcinoma. Surgery. 2022 Jun;171(6):1596-1604. doi: 10.1016/j.surg.2021.11.012. Epub 2021 Dec 13.

  PMID: 34916072 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Emilia Kruk, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilia Kruk, MD

CONTACT

+48 22 599 2545; emilia.kruk1@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2030
• Last Updated: November 19, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)