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

IF 7.5 1区 医学 Q1 SURGERY Annals of surgery Pub Date : 2025-02-05 DOI:10.1097/SLA.0000000000006651
Joerg Kaiser, Willem Niesen, Ulf Hinz, Markus K Diener, Frank Pianka, Rosa Klotz, Oliver Strobel, Arianeb Mehrabi, Christoph Berchtold, Beat Müller, Martin Schneider, Martin Loos, Christoph Michalski, Markus W Büchler, Thilo Hackert, Pascal Probst
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Abstract

Objective: Intraabdominal drainage following left pancreatectomy (LP) has been a longstanding practice to mitigate postoperative complications, particularly postoperative pancreatic fistulas (POPF).

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

Methods: The PANDRA II trial was a randomized controlled non-inferiority 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 non-inferiority to the drain group in terms of CCI (13.90 ± 16.51 vs. 19.43 ± 16.92, P<0.001 for non-inferiority). Moreover, the no-drain group had lower overall complication rates (50.41% vs. 78.40%, P<0.001). Specific complications such as POPF (14.88% vs. 20.8%, P=0.226) and postpancreatectomy hemorrhage (PPH) (4.96% vs. 4.80%, P>0.999) did not differ significantly between groups.

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

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目的:左侧胰腺切除术(LP)后腹腔引流是一种长期的做法,可减轻术后并发症,尤其是术后胰瘘(POPF):最近的研究对常规引流的必要性提出了质疑,认为省略引流可能会带来益处:PANDRA II 试验是海德堡大学医院在 2017 年至 2023 年期间开展的一项随机对照非劣效性研究。该试验比较了接受开腹或微创腹腔镜手术的患者在有无腹腔引流情况下的治疗效果。主要终点是以综合并发症指数(CCI)评估的术后总发病率:结果:共有246名患者被纳入意向治疗分析(125人有引流,121人无引流)。就 CCI(13.90 ± 16.51 vs. 19.43 ± 16.92,P0.999)而言,无引流组不劣于引流组,组间差异不显著:PANDRA II试验结果表明,就CCI测量的发病率而言,LP术后不进行常规腹腔引流并不优于常规腹腔引流。省略常规腹腔引流甚至还能显著降低总体并发症发生率。
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来源期刊
Annals of surgery
Annals of surgery 医学-外科
CiteScore
14.40
自引率
4.40%
发文量
687
审稿时长
4 months
期刊介绍: The Annals of Surgery is a renowned surgery journal, recognized globally for its extensive scholarly references. It serves as a valuable resource for the international medical community by disseminating knowledge regarding important developments in surgical science and practice. Surgeons regularly turn to the Annals of Surgery to stay updated on innovative practices and techniques. The journal also offers special editorial features such as "Advances in Surgical Technique," offering timely coverage of ongoing clinical issues. Additionally, the journal publishes monthly review articles that address the latest concerns in surgical practice.
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