使用超声外科吸引器（CUSA）进行胰腺横断术对胰十二指肠切除术后胰瘘发生率的影响（PANCUT）：一项随机对照试验的研究方案
Influence of pancreas transection with cavitron ultrasonic surgical aspirator (CUSA) on incidence of postoperative pancreatic fistula after pancreatoduodenectomy (PANCUT): study protocol for a randomised controlled trial.
作者信息
Hadžialjević Benjamin, Zavrtanik Čarni Hana, Petrič Miha, Đokić Mihajlo, Trotovšek Blaž, Tomažič Aleš, Badovinac David
机构信息
Department of Abdominal Surgery, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Department of Surgery, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
出版信息
Trials. 2025 Jun 4;26(1):190. doi: 10.1186/s13063-025-08898-4.
BACKGROUND
Complications after pancreatoduodenectomy occur in up to 40% of patients. Postoperative pancreatic fistula (POPF) remains the most common complication after pancreatoduodenectomy and is associated with increased postoperative mortality. The cavitron ultrasonic surgical aspirator (CUSA) is a surgical instrument commonly used in liver and neurosurgery. The CUSA selectively dissects tissue parenchyma, leaving blood vessels and bile ducts undamaged, which are then selectively ligated or clipped. Only a few studies have investigated the relationship between the transection of pancreatic tissue with CUSA and the formation of POPF. The results were inconsistent and were published before the updated ISGPS consensus on the definition of POPF.
METHODS
The PANCUT study is a randomised controlled trial initiated at the Department of Abdominal Surgery, University Medical Centre Ljubljana. The aim of the study is to determine whether precise dissection of the pancreatic tissue with CUSA reduces the incidence of POPF. Patients scheduled for pancreatoduodenectomy will be randomly assigned to either the experimental group, in which the pancreatic tissue will be dissected with CUSA, or the control group, in which pancreas will be conventionally transected with scalpel. A total of 180 patients will be included in the study. The primary endpoint is the formation of POPF. Secondary endpoints include operation time, amount of intraoperative blood loss, postoperative infectious complications, postoperative bleeding, length of hospital stay and mortality.
DISCUSSION
To our knowledge, the PANCUT study is the first randomized controlled trial to investigate the role of CUSA in the transection of pancreatic tissue during pancreatoduodenectomy.
TRIAL REGISTRATION
ClinicalTrials.gov NCT06135012. Registered on 18 November 2023.
背景
胰十二指肠切除术后并发症的发生率高达40%。术后胰瘘（POPF）仍然是胰十二指肠切除术后最常见的并发症，并且与术后死亡率增加相关。超声外科吸引器（CUSA）是一种常用于肝脏和神经外科手术的器械。CUSA可选择性地分离组织实质，使血管和胆管不受损伤，然后对其进行选择性结扎或夹闭。仅有少数研究探讨了使用CUSA横断胰腺组织与POPF形成之间的关系。研究结果并不一致，且这些研究是在国际胰腺外科研究组（ISGPS）关于POPF定义的更新共识发布之前发表的。
方法
PANCUT研究是在卢布尔雅那大学医学中心腹部外科开展的一项随机对照试验。该研究的目的是确定使用CUSA精确分离胰腺组织是否能降低POPF的发生率。计划接受胰十二指肠切除术的患者将被随机分配至试验组（使用CUSA分离胰腺组织）或对照组（使用手术刀常规横断胰腺）。该研究共纳入180例患者。主要终点是POPF的形成。次要终点包括手术时间、术中失血量、术后感染性并发症、术后出血、住院时间和死亡率。
讨论
据我们所知，PANCUT研究是第一项探讨CUSA在胰十二指肠切除术期间横断胰腺组织中作用的随机对照试验。
试验注册
ClinicalTrials.gov NCT06135012。于2023年11月18日注册。
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