Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-24 @ 6:29 AM
Study NCT ID:
NCT07237204
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
15 vs 45 Minute Pringle Maneuver in Liver Cancer Resection: Randomized Noninferiority Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Posthepatectomy liver failure', 'timeFrame': 'On or after postoperative day 5', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Intraoperative blood loss', 'timeFrame': 'At the completion of the surgery', 'description': '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.'}, {'measure': 'Parenchymal transection time', 'timeFrame': 'At the completion of the surgery', 'description': 'Time elapsed from the start of liver parenchymal transection to completion of parenchymal transection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pringle manouver', 'Liver malignancy', 'Liver resection'], 'conditions': ['Liver Cancer, Adult', 'Metastases to Liver', 'Liver Malignant Tumors']}, 'referencesModule': {'references': [{'pmid': '38057769', 'type': 'BACKGROUND', 'citation': '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': '21147188', 'type': 'BACKGROUND', 'citation': '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': '37787778', 'type': 'BACKGROUND', 'citation': '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': '34658153', 'type': 'BACKGROUND', 'citation': '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': '32933844', 'type': 'BACKGROUND', 'citation': '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': '34916072', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\nIs the incidence of post-hepatectomy liver failure different between 15-minute and 45-minute Pringle maneuver durations?\n\n* Do the durations differ in operative time or intraoperative blood loss?\n* 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.\n\nParticipants will:\n\n* Undergo standard oncologic hepatectomy with the assigned Pringle duration.\n* Receive routine perioperative assessments, including laboratory tests and clinical evaluations.\n* Attend follow-up visits at approximately 6 months, 1 year, and 3 years after surgery.', 'detailedDescription': "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.\n\nDuring 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.\n\nIn 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.\n\nThe 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.\n\nCollected 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.\n\nAn 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of a primary or secondary malignant liver tumor.\n* Age \\> 18 years.\n* Patient deemed eligible for liver resection.\n* WHO performance status ≤ 2.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Liver cirrhosis.\n* Liver dysfunction classified as Child-Pugh class B or C.\n* Repeat hepatectomy.\n* Prior ablation or chemoembolization of hepatic lesions.\n* Prior portal vein branch embolization.\n* Planned or performed ALPPS procedure.\n* Concomitant resection of any organ other than the gallbladder during the same operation.'}, 'identificationModule': {'nctId': 'NCT07237204', 'briefTitle': '15 vs 45 Minute Pringle Maneuver in Liver Cancer Resection: Randomized Noninferiority Trial', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'A Prospective, Randomized Noninferiority Trial Comparing 15- and 45-minute Pringle Maneuvers During Liver Resection for Oncologic Indications.', 'orgStudyIdInfo': {'id': 'KB/115/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '15 minute Pringle manouver with 10 minute reperfusion', 'description': 'Hepatic pedicle clamping for 15 minutes, followed by a 10-minute declamping period during liver transection.', 'interventionNames': ['Procedure: Pringle manouver']}, {'type': 'EXPERIMENTAL', 'label': '45 minute Pringle manouver with 15 minute reperfusion', 'description': 'Hepatic pedicle clamping for 45 minutes, followed by a 15-minute declamping period during liver transection.', 'interventionNames': ['Procedure: Pringle manouver']}], 'interventions': [{'name': 'Pringle manouver', 'type': 'PROCEDURE', 'description': 'The Pringle maneuver involves temporary clamping of the hepatic pedicle during liver resection to reduce blood loss during parenchymal transection.', 'armGroupLabels': ['15 minute Pringle manouver with 10 minute reperfusion', '45 minute Pringle manouver with 15 minute reperfusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-091', 'city': 'Warsaw', 'country': 'Poland', 'contacts': [{'name': 'Emilia Kruk, MD', 'role': 'CONTACT', 'email': 'emilia.kruk1@wum.edu.pl', 'phone': '+ 48 22 599 2545'}, {'role': 'CONTACT', 'email': 'emiliakruk1@gmail.com'}, {'name': 'Emilia Kruk, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of General, Transplant and Liver Surgery, Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Emilia Kruk, MD', 'role': 'CONTACT', 'email': 'emilia.kruk1@wum.edu.pl', 'phone': '+48 22 599 2545'}], 'overallOfficials': [{'name': 'Emilia Kruk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Warsaw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}