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左胰腺切除术后腹部引流的再思考:随机对照PANDRA II试验

Reconsidering Abdominal Drainage After Left Pancreatectomy: The Randomized Controlled PANDRA II Trial.

作者信息

Kaiser Joerg, Niesen Willem, Hinz Ulf, Diener Markus K, Pianka Frank, Klotz Rosa, Strobel Oliver, Mehrabi Arianeb, Berchtold Christoph, Müller Beat, Schneider Martin, Loos Martin, Michalski Christoph, Büchler Markus W, Hackert Thilo, Probst Pascal

机构信息

Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Germany.

Department of General, Visceral and Thoracic Surgery, Klinikum Nuernberg, Germany.

出版信息

Ann Surg. 2025 Aug 1;282(2):203-209. doi: 10.1097/SLA.0000000000006651. Epub 2025 Feb 5.

DOI:10.1097/SLA.0000000000006651
PMID:39907004
Abstract

OBJECTIVE

To evaluate intra-abdominal drainage after left pancreatectomy (LP), as it has been a longstanding practice to mitigate postoperative complications, particularly postoperative pancreatic fistulas.

BACKGROUND

Recent studies challenge the necessity of routine drainage, suggesting potential benefits in omitting drains.

METHODS

The PANDRA II trial was a randomized controlled noninferiority study conducted at the University Hospital Heidelberg between 2017 and 2023. It compared outcomes between patients undergoing open or minimally invasive LP with and without abdominal drainage. The primary endpoint was overall postoperative morbidity assessed by the Comprehensive Complication Index (CCI).

RESULTS

A total of 246 patients were included in the intention-to-treat analysis (125 with drainage, 121 without drainage). The no-drain group demonstrated noninferiority to the drain group in terms of CCI (13.90 ± 16.51 vs 19.43 ± 16.92, P < 0.001 for noninferiority). Moreover, the no-drain group had lower overall complication rates (50.41% vs 78.40%, P < 0.001). Specific complications such as postoperative pancreatic fistula (14.88% vs 20.8%, P = 0.226) and postpancreatectomy hemorrhage (4.96% vs 4.80%, P > 0.999) did not differ significantly between groups.

CONCLUSIONS

The results of the PANDRA II trial demonstrate that omitting routine abdominal drainage after LP is noninferior to placing routine abdominal drainage regarding morbidity measured by the CCI. Omitting a routine abdominal drainage even led to a significant reduction in the overall complication rate.

摘要

目的

评估左半胰切除术后的腹腔引流情况,长期以来一直采用该方法来减轻术后并发症,尤其是术后胰瘘。

背景

近期研究对常规引流的必要性提出质疑,表明不放置引流管可能有潜在益处。

方法

PANDRA II试验是一项于2017年至2023年在海德堡大学医院进行的随机对照非劣效性研究。该研究比较了接受开放性或微创左半胰切除术且有或无腹腔引流患者的结局。主要终点是通过综合并发症指数(CCI)评估的总体术后发病率。

结果

意向性分析共纳入246例患者(125例有引流,121例无引流)。在CCI方面,无引流组不劣于引流组(13.90±16.51 vs 19.43±16.92,非劣效性P<0.001)。此外,无引流组的总体并发症发生率更低(50.41% vs 78.40%,P<0.001)。术后胰瘘(14.88% vs 20.8%,P=0.226)和胰切除术后出血(4.96% vs 4.80%,P>0.999)等特定并发症在两组之间无显著差异。

结论

PANDRA II试验结果表明,左半胰切除术后不进行常规腹腔引流在以CCI衡量的发病率方面不劣于放置常规腹腔引流。不进行常规腹腔引流甚至导致总体并发症发生率显著降低。

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