Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China.
Department of Hepatobiliary Surgery, First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China; Department of Hepatobiliary and Pancreatic Oncology, Chongqing University Cancer Hospital, Chongqing, Chongqing Municipality, China; Department of Hepatobiliary Pancreatic Surgery, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan Province, China.
Lancet Gastroenterol Hepatol. 2021 Jun;6(6):438-447. doi: 10.1016/S2468-1253(21)00054-6. Epub 2021 Apr 27.
The benefit and safety of laparoscopic pancreatoduodenectomy (LPD) for the treatment of pancreatic or periampullary tumours remain controversial. Studies have shown that the learning curve plays an important role in LPD, yet there are no randomised studies on LPD after the surgeons have surmounted the learning curve. The aim of this trial was to compare the outcomes of open pancreatoduodenectomy (OPD) with those of LPD, when performed by experienced surgeons.
In this multicentre, open-label, randomised controlled trial done in 14 Chinese medical centres, we recruited patients aged 18-75 years with a benign, premalignant, or malignant indication for pancreatoduodenectomy. Eligible patients were randomly assigned (1:1) to undergo either LPD or OPD. Randomisation was centralised via a computer-generated system that used a block size of four. The patients and surgeons were unmasked to study group, whereas the data collectors, outcome assessors, and data analysts were masked. LPD and OPD were performed by experienced surgeons who had already done at least 104 LPD operations. The primary outcome was the postoperative length of stay. The criteria for discharge were based on functional recovery, and analyses were done on a modified intention-to-treat basis (ie, including patients who had a pancreatoduodenectomy regardless of whether the operation was the one they were assigned to). This trial is registered with Clinicaltrials.gov, number NCT03138213.
Between May 18, 2018, and Dec 19, 2019, we assessed 762 patients for eligibility, of whom 656 were randomly assigned to either the LPD group (n=328) or the OPD group (n=328). 31 patients in each group were excluded and 80 patients crossed over (33 from LPD to OPD, 47 from OPD to LPD). In the modified intention-to-treat analysis (297 patients in the LPD group and 297 patients in the OPD group), the postoperative length of stay was significantly shorter for patients in the LPD group than for patients in the OPD group (median 15·0 days [95% CI 14·0-16·0] vs 16·0 days [15·0-17·0]; p=0·02). 90-day mortality was similar in both groups (five [2%] of 297 patients in the LPD group vs six [2%] of 297 in the OPD group, risk ratio [RR] 0·83 [95% CI 0·26-2·70]; p=0·76). The incidence rate of serious postoperative morbidities (Clavien-Dindo grade of at least 3) was not significantly different in the two groups (85 [29%] of 297 patients in the LPD group vs 69 [23%] of 297 patients in OPD group, RR 1·23 [95% CI 0·94-1·62]; p=0·13). The comprehensive complication index score was not significantly different between the two groups (median score 8·7 [IQR 0·0-26·2] vs 0·0 [0·0-20·9]; p=0·06).
In highly experienced hands, LPD is a safe and feasible procedure. It was associated with a shorter length of stay and similar short-term morbidity and mortality rates to OPD. Nonetheless, the clinical benefit of LPD compared with OPD was marginal despite extensive procedural expertise. Future research should focus on identifying the populations that will benefit from LPD.
National Natural Science Foundation of China and Tongji Hospital, Huazhong University of Science and Technology, China.
腹腔镜胰十二指肠切除术（LPD）治疗胰腺或壶腹周围肿瘤的益处和安全性仍存在争议。研究表明，学习曲线在 LPD 中起着重要作用，但对于外科医生克服学习曲线后进行的 LPD，尚无随机研究。本试验旨在比较经验丰富的外科医生进行的开腹胰十二指肠切除术（OPD）与 LPD 的结果。
本研究是在 14 家中国医疗中心进行的一项多中心、开放标签、随机对照试验，招募了年龄在 18-75 岁之间、有良性、癌前或恶性胰十二指肠切除术指征的患者。符合条件的患者被随机分配（1:1）接受 LPD 或 OPD。通过计算机生成的系统进行中央随机化，该系统使用大小为 4 的块。患者和外科医生对研究组均不设盲，但数据收集者、结果评估者和数据分析者设盲。LPD 和 OPD 由至少完成 104 例 LPD 手术的有经验的外科医生进行。主要结局是术后住院时间。出院标准基于功能恢复，分析采用改良意向治疗（即包括进行胰十二指肠切除术的患者，无论他们接受的手术是否为分配给他们的手术）。本试验在 Clinicaltrials.gov 上注册，编号为 NCT03138213。
2018 年 5 月 18 日至 2019 年 12 月 19 日，我们评估了 762 名患者的纳入资格，其中 656 名患者被随机分配至 LPD 组（n=328）或 OPD 组（n=328）。每组有 31 名患者被排除，80 名患者交叉（33 名从 LPD 转为 OPD，47 名从 OPD 转为 LPD）。在改良意向治疗分析（LPD 组 297 例，OPD 组 297 例）中，LPD 组患者的术后住院时间明显短于 OPD 组（中位数 15.0 天[95%CI 14.0-16.0]比 16.0 天[15.0-17.0]；p=0.02）。两组 90 天死亡率相似（LPD 组 5 例[2%]，OPD 组 6 例[2%]，风险比[RR]0.83[95%CI 0.26-2.70]；p=0.76）。两组严重术后并发症发生率（Clavien-Dindo 分级至少为 3 级）无显著差异（LPD 组 297 例中有 85 例[29%]，OPD 组 297 例中有 69 例[23%]，RR 1.23[95%CI 0.94-1.62]；p=0.13）。两组综合并发症指数评分无显著差异（中位数评分 8.7[IQR 0.0-26.2]比 0.0[0.0-20.9]；p=0.06）。
在经验丰富的外科医生手中，LPD 是一种安全可行的手术。它与 OPD 相比，术后住院时间更短，短期发病率和死亡率相似。尽管手术技术非常复杂，但 LPD 与 OPD 相比，其临床获益仍微不足道。未来的研究应集中在确定哪些人群将从 LPD 中受益。
国家自然科学基金和华中科技大学同济医院，中国。
