Department of Surgery, Hospital del Mar, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona, Spain.
Department of Surgery, Universitat Autònoma de Barcelona, Barcelona, Spain.
Ann Surg. 2018 Nov;268(5):731-739. doi: 10.1097/SLA.0000000000002893.
To compare perioperative outcomes of pancreatoduodenectomy (PD) performed through the laparoscopic route or by open surgery.
Laparoscopic PD is being progressively performed in selected patients.
An open-label single-center RCT was conducted between February 2013 and September 2017. The primary endpoint was the length of hospital stay (LOS). Secondary endpoints were operative time, transfusion requirements, specific pancreatic complications (pancreatic or biliary fistula, pancreatic hemorrhage, and delayed gastric emptying), Clavien-Dindo grade ≥ 3 complications, comprehensive complication index (CCI) score, poor quality outcome (PQO), and the quality of pathologic resection. Analyses were performed on an intention to treat basis.
Of 86 patients assessed for PD, 66 were randomized (34 laparoscopic approach, 32 open surgery). Conversion to an open procedure was needed in 8 (23.5%) patients. Laparoscopic versus open PD was associated with a significantly shorter LOS (median 13.5 vs. 17 d; P = 0.024) and longer median operative time (486 vs. 365 min; P = 0.0001). The laparoscopic approach was associated with significantly better outcomes regarding Clavien-Dindo grade ≥ 3 complications (5 vs. 11 patients; P = 0.04), CCI score (20.6 vs. 29.6; P = 0.038), and PQO (10 vs. 14 patients; P = 0.041). No significant differences in transfusion requirements, pancreas-specific complications, the number of lymph nodes retrieved, and resection margins between the two approaches were found.
Laparoscopic PD versus open surgery is associated with a shorter LOS and a more favorable postoperative course while maintaining oncological standards of a curative-intent surgical resection.
ISRCTN93168938.
比较腹腔镜胰十二指肠切除术（PD）与开腹手术的围手术期结果。
腹腔镜 PD 正在被选择性地应用于部分患者。
这是一项于 2013 年 2 月至 2017 年 9 月期间在单中心开展的、开放标签的随机对照试验。主要终点是住院时间（LOS）。次要终点包括手术时间、输血需求、特定的胰腺并发症（胰瘘或胆瘘、胰腺出血和胃排空延迟）、Clavien-Dindo 分级≥3 级并发症、综合并发症指数（CCI）评分、不良质量结局（PQO）和病理切除质量。分析基于意向治疗原则进行。
在评估 PD 的 86 例患者中，有 66 例被随机分为腹腔镜组（34 例）和开腹组（32 例）。8 例（23.5%）患者需要转为开腹手术。与开腹 PD 相比，腹腔镜 PD 具有显著更短的 LOS（中位数 13.5 比 17 天；P=0.024）和更长的中位手术时间（486 比 365 分钟；P=0.0001）。腹腔镜组在 Clavien-Dindo 分级≥3 级并发症（5 例比 11 例；P=0.04）、CCI 评分（20.6 比 29.6；P=0.038）和 PQO（10 例比 14 例；P=0.041）方面的结果显著更好。两组间输血需求、胰腺特异性并发症、淋巴结检出数量和切缘情况无显著差异。
与开腹手术相比，腹腔镜 PD 具有更短的 LOS 和更有利的术后转归，同时保持了根治性手术的肿瘤学标准。
ISRCTN93168938。
