Korrel Maarten, Jones Leia R, van Hilst Jony, Balzano Gianpaolo, Björnsson Bergthor, Boggi Ugo, Bratlie Svein Olav, Busch Olivier R, Butturini Giovanni, Capretti Giovanni, Casadei Riccardo, Edwin Bjørn, Emmen Anouk M L H, Esposito Alessandro, Falconi Massimo, Groot Koerkamp Bas, Keck Tobias, de Kleine Ruben H J, Kleive Dyre B, Kokkola Arto, Lips Daan J, Lof Sanne, Luyer Misha D P, Manzoni Alberto, Marudanayagam Ravi, de Pastena Matteo, Pecorelli Nicolò, Primrose John N, Ricci Claudio, Salvia Roberto, Sandström Per, Vissers Frederique L I M, Wellner Ulrich F, Zerbi Alessandro, Dijkgraaf Marcel G W, Besselink Marc G, Abu Hilal Mohammad
Department of General Surgery, Istituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy.
Amsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands.
Lancet Reg Health Eur. 2023 Jul 6;31:100673. doi: 10.1016/j.lanepe.2023.100673. eCollection 2023 Aug.
The oncological safety of minimally invasive surgery has been questioned for several abdominal cancers. Concerns also exist regarding the use of minimally invasive distal pancreatectomy (MIDP) in patients with resectable pancreatic cancer as randomised trials are lacking.
In this international randomised non-inferiority trial, we recruited adults with resectable pancreatic cancer from 35 centres in 12 countries. Patients were randomly assigned to either MIDP (laparoscopic or robotic) or open distal pancreatectomy (ODP). Both patients and pathologists were blinded to the assigned approach. Primary endpoint was radical resection (R0, ≥1 mm free margin) in patients who had ultimately undergone resection. Analyses for the primary endpoint were by modified intention-to-treat, excluding patients with missing data on primary endpoint. The pre-defined non-inferiority margin of -7% was compared with the lower limit of the two-sided 90% confidence interval (CI) of absolute difference in the primary endpoint. This trial is registered with the ISRCTN registry (ISRCTN44897265).
Between May 8, 2018 and May 7, 2021, 258 patients were randomly assigned to MIDP (131 patients) or ODP (127 patients). Modified intention-to-treat analysis included 114 patients in the MIDP group and 110 patients in the ODP group. An R0 resection occurred in 83 (73%) patients in the MIDP group and in 76 (69%) patients in the ODP group (difference 3.7%, 90% CI -6.2 to 13.6%; p = 0.039). Median lymph node yield was comparable (22.0 [16.0-30.0] vs 23.0 [14.0-32.0] nodes, p = 0.86), as was the rate of intraperitoneal recurrence (41% vs 38%, p = 0.45). Median follow-up was 23.5 (interquartile range 17.0-30.0) months. Other postoperative outcomes were comparable, including median time to functional recovery (5 [95% CI 4.5-5.5] vs 5 [95% CI 4.7-5.3] days; p = 0.22) and overall survival (HR 0.99, 95% CI 0.67-1.46, p = 0.94). Serious adverse events were reported in 23 (18%) of 131 patients in the MIDP group vs 28 (22%) of 127 patients in the ODP group.
This trial provides evidence on the non-inferiority of MIDP compared to ODP regarding radical resection rates in patients with resectable pancreatic cancer. The present findings support the applicability of minimally invasive surgery in patients with resectable left-sided pancreatic cancer.
Medtronic Covidien AG, Johnson & Johnson Medical Limited, Dutch Gastroenterology Society.
微创手术对几种腹部癌症的肿瘤学安全性一直受到质疑。由于缺乏随机试验，对于可切除胰腺癌患者使用微创远端胰腺切除术（MIDP）也存在担忧。
在这项国际随机非劣效性试验中，我们从12个国家的35个中心招募了患有可切除胰腺癌的成年人。患者被随机分配接受MIDP（腹腔镜或机器人手术）或开放远端胰腺切除术（ODP）。患者和病理学家均对分配的手术方式不知情。主要终点是最终接受手术切除的患者中的根治性切除（R0，切缘阴性≥1毫米）。对主要终点的分析采用改良意向性分析，排除主要终点数据缺失的患者。将预先设定的非劣效性界值-7%与主要终点绝对差异的双侧90%置信区间（CI）下限进行比较。本试验已在国际标准随机对照试验编号注册库（ISRCTN44897265）注册。
在2018年5月8日至2021年5月7日期间，258例患者被随机分配至MIDP组（131例患者）或ODP组（127例患者）。改良意向性分析纳入MIDP组114例患者和ODP组110例患者。MIDP组83例（73%）患者实现R0切除，ODP组76例（69%）患者实现R0切除（差异3.7%，90%CI -6.2至13.6%；p = 0.039）。中位淋巴结收获数相当（22.0[16.0 - 30.0]枚对23.0[14.0 - 32.0]枚，p = 0.86），腹腔内复发率也相当（41%对38%，p = 0.45）。中位随访时间为23.5（四分位间距17.0 - 30.0）个月。其他术后结局相当，包括功能恢复的中位时间（5[95%CI 4.5 - 5.5]天对5[95%CI 4.7 - 5.3]天；p = 0.22）和总生存期（风险比0.99，95%CI 0.67 - 1.46，p = 0.94）。MIDP组131例患者中有23例（18%）报告了严重不良事件，ODP组127例患者中有28例（22%）报告了严重不良事件。
本试验提供了证据，表明在可切除胰腺癌患者中，MIDP与ODP相比在根治性切除率方面非劣效。目前的研究结果支持微创手术在可切除左侧胰腺癌患者中的适用性。
美敦力柯惠公司、强生医疗有限公司、荷兰胃肠病学会。
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