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