Liver Cancer, AdultNCT07237204
15 vs 45 Minute Pringle Maneuver in Liver Cancer Resection: Randomized Noninferiority Trial
A study testing Pringle manouver in people with Liver Cancer, Adult and Metastases to Liver, run by Medical University of Warsaw at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Adult, Metastases to Liver, Liver Malignant Tumors
- What is being tested?
- Pringle manouver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2025to 1 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Department of General, Transplant and Liver Surgery, Medical University of Warsaw
Warsaw, 02-091
Emilia Kruk, MD, + 48 22 599 2545, emilia.kruk1@wum.edu.pl
emiliakruk1@gmail.com
About this study
Official title: 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?
Read more
- 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.
Read the 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.
- Being tested
- Pringle manouver
- Keywords
- Pringle manouver, Liver malignancy, Liver resection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pringle manouverProcedure or surgery
The Pringle maneuver involves temporary clamping of the hepatic pedicle during liver resection to reduce blood loss during parenchymal transection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Pringle manouver |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On or after postoperative day 5
Secondary outcomes (2)
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.
Measured: At the completion of the surgery
Parenchymal transection time
Time elapsed from the start of liver parenchymal transection to completion of parenchymal transection.
Measured: At the completion of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Liver Cancer, AdultStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilia Kruk, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237204
- Sponsor's protocol ID
- KB/115/2025
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38057769van 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.
PubMed 21147188Doi 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.
PubMed 37787778Liu 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.
PubMed 34658153Fagenson 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.
PubMed 32933844Huang 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.
PubMed 34916072
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Noninferiority Trial Comparing 15- and 45-minute Pringle Maneuvers During Liver Resection for Oncologic Indications.
- ClinicalTrials.gov ID
- NCT07237204
- Acronym / sponsor ID
- KB/115/2025
- Keywords
- Pringle manouver, Liver malignancy, Liver resection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 15 minute Pringle manouver with 10 minute reperfusion | Experimental | Procedure: Pringle manouverHepatic pedicle clamping for 15 minutes, followed by a 10-minute declamping period during liver transection. |
| 45 minute Pringle manouver with 15 minute reperfusion | Experimental | Procedure: Pringle manouverHepatic pedicle clamping for 45 minutes, followed by a 15-minute declamping period during liver transection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pringle manouverThe Pringle maneuver involves temporary clamping of the hepatic pedicle during liver resection to reduce blood loss during parenchymal transection. | Procedure or surgery | 15 minute Pringle manouver with 10 minute reperfusion, 45 minute Pringle manouver with 15 minute reperfusion |
Primary outcome
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.
2 secondary outcomes
Intraoperative blood loss
Time frame: At the completion of the surgery
Parenchymal transection time
Time frame: At the completion of the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Background: PubMed 38057769Wang 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.
- Background: PubMed 21147188van 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.
- Background: PubMed 37787778Doi 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.
- Background: PubMed 34658153Liu 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.
- Background: PubMed 32933844Fagenson 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.
- Background: PubMed 34916072Huang 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emilia Kruk, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pringle manouver in people with Liver Cancer, Adult and Metastases to Liver, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilia Kruk, MD (+48 22 599 2545, emilia.kruk1@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posthepatectomy liver failure (time frame: On or after postoperative day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07237204, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.