Evidence map›Paper›PMID 40468382›Full record

ArticleTrials2025

Effect of 15- or 25-min intermittent Pringle maneuver on early recurrence of hepatocellular carcinoma after hepatectomy: a protocol for a randomized controlled trial.

Xuehai Jia, Anque Liao, Yang Huang, Xiangyu Du, Li Jiang

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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4 · The record

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5 · Who and what money

Authors and funding

5 authors.

Xuehai Jia *Division of Liver Surgery, Department of General Surgery, West China Hospital of Sichuan University, Chengdu, Sichuan Province, 610041, China.
Anque Liao *Department of Operation Center, West China Hospital/West China School of Nursing, Sichuan University, Chengdu, China.
Yang HuangDivision of Liver Surgery, Department of General Surgery, West China Hospital of Sichuan University, Chengdu, Sichuan Province, 610041, China.
Xiangyu DuDivision of Liver Surgery, Department of General Surgery, West China Hospital of Sichuan University, Chengdu, Sichuan Province, 610041, China.
Li JiangDivision of Liver Surgery, Department of General Surgery, West China Hospital of Sichuan University, Chengdu, Sichuan Province, 610041, China. jl339@126.com.

Funding

Key Clinical Research Incubation Project of West China Hospital of Sichuan University 2020HXFH028Key R&D Support Plan of Chengdu Science and Technology Bureau 2021-YF05-00703-SNSichuan Natural Science Foundation project 24NSFSC0237Sichuan Province Key Research and Development Project 2019YFS0203Sichuan Province Key Research and Development Project 2022YFS0090
6 · The paper itself

Abstract

backgroundAmong various blood flow control techniques, the intermittent Pringle's maneuver (IPM) remains the most convenient and widely used method for reducing bleeding during hepatic resection (HR). However, the impact of IPM on human hepatocellular carcinoma (HCC) recurrence is still unclear. To date, no randomized controlled trial (RCT) has directly evaluated the impact of IPM on the tumor recurrence in HCC patients undergoing HR. Since 2019, our team has been investigating the effects of 25-min IPM on liver function and post-hepatectomy safety in HCC patients. To date, we have published two RCTs that confirm the safety and feasibility of 25-min IPM for HCC patients with Child-Pugh grade A liver function. However, these studies focused exclusively on short-term outcomes and did not assess tumor recurrence. Therefore, we are designing this RCT to compare the effects of 15-min IPM with 25-min IPM on early tumor recurrence in HCC patients undergoing HR.

methodsThis will be a single-center, parallel, double-blind, randomized controlled trial. A total of 334 consecutive patients who meet the inclusion and exclusion criteria will be enrolled and randomized into either the 15-min IPM group or the 25-min IPM group in a 1:1 ratio using a randomization protocol. Patients will be followed for 2 years after surgery. DISCUSSION: We designed this protocol to compare the effects of two different IPM methods on tumor recurrence in HCC patients undergoing HR, which will provide significant guidance for surgeons. Firstly, this study design is practical and feasible in clinical practice. Secondly, this RCT will encompass various types of HR procedures (including laparoscopic or open HR, as well as minor or major hepatectomy), ensuring a representative clinical application. Thirdly, to our knowledge, this is the first RCT to compare the effects of 15- and 25-min IPM on early recurrence of HCC.

trial registrationThis trial was registered on April 29, 2024, in the Chinese Clinical Trial Registry ( http://www.chictr.org.cn ), under the registration number ChiCTR2400083647. The protocol version is V1.0 (20,240,429).

Indexed as

Blood Loss, SurgicalCarcinoma, HepatocellularHepatectomyLiver NeoplasmsNeoplasm Recurrence, LocalDouble-Blind MethodFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeClinical trial protocolHepatectomyHepatocellular carcinomaIschemia/reperfusion injuryLocalNeoplasm recurrencePringle maneuver

Identifiers

PMID40468382
PMCPMC12139119

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.