Prophylactic passive abdominal drainage is standard practice after distal pancreatectomy. This approach aims to mitigate the consequences of postoperative pancreatic fistula (POPF) but its added value, especially in patients at low risk of POPF, is currently being debated. We aimed to assess the non-inferiority of a no-drain policy in patients after distal pancreatectomy. In this international, multicentre, open-label, randomised controlled, non-inferiority trial, we recruited patients aged 18 years or older undergoing open or minimally invasive elective distal pancreatectomy for all indications in 12 centres in the Netherlands and Italy. We excluded patients with an American Society of Anesthesiology (ASA) physical status of 4–5 or WHO performance status of 3–4, added by amendment following the death of a patient with ASA 4 due to a pre-existing cardiac condition. Patients were randomly assigned (1:1) intraoperatively by permuted blocks (size four to eight) to either no drain or prophylactic passive drain placement, stratified by annual centre volume (<40 or ≥40 distal pancreatectomies) and low risk or high risk of grade B or C POPF. High-risk was defined as a pancreatic duct of more than 3 mm in diameter, a pancreatic thickness at the neck of more than 19 mm, or both, based on the Distal Pancreatectomy Fistula Risk Score. Other patients were considered low-risk. The primary outcome was the rate of major morbidity (Clavien–Dindo score ≥III), and the most relevant secondary outcome was grade B or C POPF, grading per the International Study Group for Pancreatic Surgery. Outcomes were assessed up to 90 days postoperatively and analysed in the intention-to-treat population and per-protocol population, which only included patients who received the allocated treatment. A prespecified non-inferiority margin of 8% was compared with the upper limit of the two-sided 95% CI (Wald) of unadjusted risk difference to assess non-inferiority. This trial is closed and registered in the Netherlands Trial Registry, NL9116. Between Oct 3, 2020, and April 28, 2023, 376 patients were screened for eligibility and 282 patients were randomly assigned to the no-drain group (n=138; 75 [54%] women and 63 [46%] men) or the drain group (n=144; 73 [51%] women and 71 [49%] men). Seven patients in the no-drain group received a drain intraoperatively; consequently, the per-protocol population included 131 patients in the no-drain group and 144 patients in the drain group. The rate of major morbidity was non-inferior in the no-drain group compared with the drain group in the intention-to-treat analysis (21 [15%] 29 [20%]; risk difference –4·9 percentage points [95% CI –13·8 to 4·0]; p=0·0022) and the per-protocol analysis (21 [16%] 29 [20%]; risk difference –4·1 percentage points [–13·2 to 5·0]; p=0·0045). Grade B or C POPF was observed in 16 (12%) patients in the no-drain group and in 39 (27%) patients in the drain group (risk difference –15·5 percentage points [95% CI –24·5 to –6·5]; p<0·0001) in the intention-to-treat analysis. Three patients in the no-drain group died within 90 days; the cause of death in two was not considered related to the trial. The third death was a patient with an ASA score of 4 who died after sepsis and a watershed cerebral infarction at second admission, leading to multiple organ failure. No patients in the drain group died within 90 days. A no-drain policy is safe in terms of major morbidity and reduced the detection of grade B or C POPF, and should be the new standard approach in eligible patients undergoing distal pancreatectomy. Ethicon UK (Johnson & Johnson Medical, Edinburgh, UK).

中文翻译：

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远端胰腺切除术后预防性腹腔引流 (PANDORINA)：一项国际、多中心、开放标签、随机对照、非劣效性试验


预防性被动腹部引流是远端胰腺切除术后的标准做法。这种方法旨在减轻术后胰瘘 (POPF) 的后果，但其附加价值，特别是对于 POPF 风险较低的患者，目前尚有争议。我们的目的是评估远端胰腺切除术后患者不引流政策的非劣效性。在这项国际、多中心、开放标签、随机对照、非劣效性试验中，我们招募了年龄在 18 岁或以上的患者，在荷兰和意大利的 12 个中心针对所有适应症接受开放式或微创选择性远端胰腺切除术。我们排除了美国麻醉学会 (ASA) 身体状况为 4-5 级或 WHO 体能状况为 3-4 级的患者，并在 ASA 4 级患者因既往心脏病死亡后进行了修正。术中将患者按排列区（大小 4 至 8）随机分配（1:1）至无引流或预防性被动引流放置，按年度中心体积（<40 或≥40 次远端胰腺切除术）和低风险或高风险进行分层。 B 级或 C 级 POPF。根据远端胰腺切除术瘘管风险评分，高风险被定义为胰管直径超过 3 毫米、颈部胰腺厚度超过 19 毫米或两者兼而有之。其他患者被认为是低风险。主要结局是主要发病率（Clavien-Dindo 评分≥III），最相关的次要结局是 B 级或 C 级 POPF，根据国际胰腺外科研究组的分级。术后 90 天对结果进行评估，并在意向治疗人群和符合方案人群中进行分析，其中仅包括接受分配治疗的患者。 将预先指定的 8% 非劣效性界限与未调整风险差异的两侧 95% CI (Wald) 上限进行比较，以评估非劣效性。该试验已结束并在荷兰试验登记处登记，NL9116。 2020年10月3日至2023年4月28日期间，对376名患者进行了资格筛查，其中282名患者被随机分配到无引流组（n=138；75名女性[54%]和63名男性[46%]）或引流组（n=144；73 [51%] 女性和 71 [49%] 男性）。无引流组中的 7 名患者在术中接受了引流；因此，符合方案的人群包括无引流组的 131 名患者和引流组的 144 名患者。在意向治疗分析中，与引流组相比，不引流组的主要发病率并不低劣（21 [15%] 29 [20%]；风险差异 –4·9 个百分点 [95 % CI –13·8 至 4·0]；p=0·0022) 和符合方案分析 (21 [16%] 29 [20%]；风险差异 –4·1 个百分点 [–13·2 至5·0]；p=0·0045)。在无引流组中的 16 名患者 (12%) 和引流组中的 39 名患者 (27%) 中观察到 B 级或 C 级 POPF（风险差异 –15·5 个百分点 [95% CI –24·5 至–6·5]；p<0·0001）在意向治疗分析中。不引流组有 3 名患者在 90 天内死亡；两人的死因被认为与审判无关。第三例死亡是一名 ASA 评分为 4 分的患者，第二次入院时因败血症和分水岭性脑梗塞死亡，导致多器官功能衰竭。引流组中没有患者在 90 天内死亡。无引流政策在主要发病率方面是安全的，并且减少了 B 级或 C 级 POPF 的检出率，并且应该成为符合条件的接受远端胰腺切除术的患者的新标准方法。 爱惜康英国（强生医疗公司，英国爱丁堡）。