Robotic versus Open Pancreatoduodenectomy (PORTAL): multicentre, single masked, phase 3, non-inferiority randomised controlled trial.

Methods

Multicentre, single masked, phase 3, non-inferiority randomised controlled trial.

多中心、单盲、第三阶段、非劣效性随机对照试验。

Seven tertiary high volume pancreatic centres in China, 15 June 2020 to 28 November 2024.

中国七家三级高容量胰腺中心，研究时间从2020年6月15日至2024年11月28日。

268 adults with resectable pancreatic or periampullary disease.

268名可进行手术切除的成人胰腺或壶腹周围疾病患者。

Participants were randomised to receive standardised RPD (n=142) or OPD (n=126), with enhanced recovery pathways.

参与者被随机分配接受标准化的RPD（n=142）或OPD（n=126），并采用增强康复路径。

The primary outcome was time from surgery to postoperative functional recovery, defined as adequate pain control without parenteral analgesia, ≥50% oral intake without intravenous fluids, independent mobilisation, and absence of active intra-abdominal infection.

主要结果是从手术到术后功能恢复的时间，定义为在没有静脉镇痛的情况下疼痛控制良好，≥50%的口服摄入量无需静脉输液，独立活动，且无活动性腹腔内感染。

The restricted mean event time (RMET) within 40 days was a summary for time from surgery to postoperative functional recovery.

40天内的限制性平均事件时间（RMET）是对手术至术后功能恢复时间的总结。

Secondary outcomes included operative metrics, disease related outcomes, length of stay, postoperative morbidity, including complications of Clavien-Dindo grade II or higher (defined as complications requiring drug treatment or more intensive intervention), and hospital admission costs.

次要结果包括手术指标、疾病相关结果、住院时间、术后发病率，包括Clavien-Dindo二级或更高级别的并发症（定义为需要药物治疗或更密集干预的并发症），以及住院费用。

Results

Overall, 254 of 268 randomly assigned participants (mean age 62 years; 172 (64.2%) men) underwent surgery, completed follow-up, and were included in the modified intention-to-treatpopulation; 14 did not undergo surgery.

总体而言，268名随机分配的参与者中有254名（平均年龄62岁；172名（64.2%）为男性）接受了手术，完成了随访，并被纳入改良意向治疗（modified intention-to-treat）人群；有14人未接受手术。

In the modified intention-to-treatpopulation, the RMET was 12.1 days (95% confidence interval(CI) 11.2 to 13.1) in the RPD group and 16.0 days (14.5 to 17.5) in the OPD group (difference -3.9 days, 95% CI -5.6 to -2.2; P<0.001).

在改良意向治疗人群中，RPD组的RMET为12.1天（95%置信区间（CI）11.2至13.1天），而OPD组为16.0天（14.5至17.5天）（差异-3.9天，95% CI -5.6至-2.2天；P<0.001）。

Operative time was longer in the RPD group (300 minutes (interquartile range (IQR) 240-360 minutes) versus 270 (210-300) minutes in the OPD group, P<0.001) but postoperative length of stay was shorter in the RPD group (13 (IQR 11-16) days v 16 (13-20) days, P<0.001).

RPD组的手术时间更长（RPD组中位手术时间为300分钟（四分位数范围（IQR）240-360分钟），而OPD组为270分钟（210-300分钟），P<0.001），但RPD组的术后住院时间更短（RPD组中位术后住院时间为13天（四分位数范围11-16天），而OPD组为16天（13-20天），P<0.001）。

Overall postoperative morbidity was 31.1% (41/132) in the RPD group versus 36.1% (44/122) in the OPD group and incidenceof any complications of Clavien-Dindo grade II or higher was 23.5% (31/132) versus 34.4% (42/122), respectively. 90 day mortality was 0.8% (1) in the RPD group and 2.5% (3) in the OPD group.

RPD组的总体术后发病率是31.1%（41/132），而OPD组为36.1%（44/122），且Clavien-Dindo II级或更高严重程度的任何并发症发生率在RPD组为23.5%（31/132），在OPD组为34.4%（42/122）。RPD组的90天死亡率为0.8%（1例），而OPD组为2.5%（3例）。

Median total costs of hospital admission (including readmission cost) were higher in the RPD group than in the OPD group (¥130 905 (£14 369; $19 351; €16 628) (IQR ¥114 853-¥152 547) v ¥108 071 (¥92 134-¥128 035), difference ¥22 834 (95% CI ¥16 744 to ¥30 522); P<0.001).

入院总成本（包括再次入院成本）在机器人辅助前列腺切除术（RPD）组中高于门诊前列腺切除术（OPD）组（¥130 905 (£14 369; $19 351; €16 628)（四分位数范围 ¥114 853-¥152 547）对比 ¥108 071（¥92 134-¥128 035），差异 ¥22 834（95% 置信区间 ¥16 744 至 ¥30 522）；P<0.001）。

Conclusions

In high volume centres with credentialled surgeons, RPD met the non-inferiority margin for time from surgery to postoperative functional recovery, with comparable disease related outcomes and overall burden from postoperative complications.

在拥有资格认证外科医生的高容量中心，机器人辅助前列腺切除术（RPD）在手术至术后功能恢复时间上达到了非劣效性边缘，疾病相关结果和术后并发症总体负担与传统手术相当。

To generate wider system level efficiency gains, the implementation of RPD should take account of institutional expertise, procedural volume, acquisition of robotic surgical platforms and maintenance costs, and the potential for shorter hospital stay.

为了实现更广泛的系统级效率提升，实施机器人辅助手术计划（RPD）应考虑机构的专业技能、手术量、机器人手术平台的购置与维护成本，以及缩短住院时间的潜力。

trial_registration

ClinicalTrials.gov NCT04400357.

ClinicalTrials.gov NCT04400357。