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Clinical value and cost-effectiveness of minimally invasive distal pancreatectomy

机译:微创胰远端切除术的临床价值和成本效益

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摘要

Minimally invasive pancreatic resection (MIPR) has gained popularity in the last decade and it is currently widely applied with selected indications in highly specialized centres worldwide. Distal pancreatectomy (DP), which lacks of a technical demanding and complex reconstruction phase, is the most suitable pancreatic resection for a minimal invasive approach and is therefore the most performed MIPR. Several non-randomized studies and meta-analyses suggested that a minimally invasive distal pancreatectomy (MIDP) could improve the short-term postoperative outcomes by reducing the intraoperative blood loss and the postoperative morbidity when compared to open distal pancreatectomy (ODP) ( ). MIDP seems also to promote an earlier recovery and a reduction in the length of postoperative stays when compared to ODP without affecting the oncologic outcomes. Therefore, the diffusion of MIDP is increasing and a minimally invasive approach is generally recognized as a suitable approach to benign, borderline malignant lesions and to Pan-NENs. The value of MIDP for the surgical treatment of pancreatic ductal adenocarcinoma (PDAC) is still under evaluation despite its feasibility and safety in this setting have been demonstrated and similar long-term oncological outcomes were reported by several single and multicentre series ( ). The recent published DIPLOMA study, a European retrospective propensity score-matched cohort study on minimally invasive versus open DP for PDAC, raised some concerns in terms of oncological adequacy of MIDP ( ). In fact, despite a similar reported overall survival between ODP and MIDP a lower lymph nodes retrieval and a lower incidence of Gerota’s fascia resection were observed in the MIDP group. Results of the LEOPARD trial, the first multicentre patient blinded randomized controlled trial comparing the outcomes of open versus MIDP (10% of minimally invasive case operated by robotic approach), showed a reduction of intra operative blood loss, delayed gastric emptying and a shorter postoperative hospital stay in the MIDP group ( ). Mortality and major complications (Clavien-Dindo ≥3 were similar between groups. Surprisingly results of 1-year follow-up of the LEOPRAD trial highlighted a higher-grade B/C pancreatic fistula rate in the MIDP group ( ). These concerning results have not been reported before and highlight the need for long-term follow-up to correctly assess not only the clinical impact of MIDP but also the quality of life and cumulative costs related to the procedure. It is therefore of paramount importance to assess late complications and readmission rates as well as the impact of a faster recovery after surgery can have on the quality of life of patients and to their return to an active working life (which also has an important effect on the social costs of a surgical procedure). Nowadays the economic and social costs of surgery have to be investigated in terms of both cost-utility and cost-effectiveness and have to be addressed from the perspective of different health care systems. Cost benefit analysis of a new surgical procedure such as MIDP should be considered a benchmark for the full implementation of new techniques since an effective allocation of the health care system economic resources is mandatory. Nevertheless, the cost-effectiveness of MIDP is still ill defined. Several studies were focused on costs comparison between open and laparoscopic DP ( - ) but few data are available on cost-effectiveness of robotic MIDP (r-MIDP), which carries in general higher operative room costs (both for materials and for length of operation related factors). Since now, only three studies addressed the comparative costs analysis of the open, laparoscopic and robotic DP ( ) ( - ). In general, as reported by Gavriilidis robotic MIDP has been associated with a 1-day reduction in hospital stay when compared to laparoscopic MIDP ( ). Whether, this benefit could balance the higher costs of r-MIDP related to surgical equipment and longer operative room time is unclear. An accurate assessment of the total costs supported by the health care system is difficult and generally biased by the different outcomes measured and discrepancy in long-term follow-up, as well as specific peculiarity of different health care systems. The recently published paper by Rodriguez ( ) is one of the few studies analysing the economic impact and the cost-effectiveness of different surgical approaches to DP. The authors reported a consecutive series of 89 patients submitted to DP at two French Institutions over a 4-year period. Patients were stratified by surgical approach: 21 were robotic (RDP), 25 laparoscopic (LDP), and 43 open (ODP). The robotic approach resulted to be associated with a lower intraoperative blood loss, an increase in splenic preservation rate and with a reduction in severe morbidity rate (Clavien-Dindo ≥ grade III). The robotic approach was associated to a longer operative time and a longer operative room costs. Interestingly, the costs of r-MIDP operation were counterbalanced by a reduction in postoperative stay and by a lower incidence of severe postoperative complications requiring extra treatment. Therefore, r-MIDP resulted to be the most cost-effective procedure even when compared to laparoscopy. In a deeper analysis of the results, it must be considered that the percentage of patients operated on for PDAC (patients at higher risk of morbidity and submitted for oncological reasons to an associated splenectomy) were highly different in the three groups (only 9.5% in the robotic group versus 32.5% and 51.1% in the laparoscopic and open group respectively). Nevertheless, the results reported by Rodriguez suggest not only the clinical impact of the robotic approach but also the potentiality in terms of costs reduction of the robotic platform applied to MIDP.
机译:在过去的十年中,微创胰腺切除术(MIPR)受到欢迎,目前已在全球高度专业化的中心广泛应用于具有特定适应症的患者。远端胰腺切除术(DP)缺乏技术要求和复杂的重建阶段,是最适合微创手术的胰腺切除术,因此是MIPR表现最强的。多项非随机研究和荟萃分析表明,与开放式远端胰腺切除术(ODP)相比,微创远端胰腺切除术(MIDP)可通过减少术中失血量和术后发病率来改善短期术后结局()。与ODP相比,MIDP似乎还可以促进早期康复并缩短术后住院时间,而不会影响肿瘤学结果。因此,MIDP的扩散正在增加,并且微创方法通常被认为是对良性,边缘性恶性病变和Pan-NENs的合适方法。尽管MIDP在这种情况下的可行性和安全性已得到证实,但MIDP在胰腺导管腺癌(PDAC)的外科治疗中的价值仍在评估中,多个单中心和多中心系列报道了类似的长期肿瘤学结局()。最近发表的DIPLOMA研究是一项针对PDAC的微创与开放式DP的欧洲回顾性倾向评分匹配队列研究,引起了关于MIDP肿瘤学充分性的一些担忧。实际上,尽管报道的ODP和MIDP总体生存率相似,但MIDP组的淋巴结恢复率较低,Gerota筋膜切除术的发生率较低。 LEOPARD试验的结果是第一个比较开放式和MIDP方案(通过机器人入路的微创病例的10%)的结局的多中心患者双盲随机对照试验,显示术中失血量减少,胃排空延迟和术后时间缩短在MIDP组中住院()。死亡率和主要并发症(两组之间的Clavien-Dindo≥3相似。LEOPRAD试验的1年随访结果令人惊讶地显示,MIDP组的B / C胰瘘级别较高)。之前尚未见过报道,因此强调需要长期随访以不仅正确评估MIDP的临床影响,而且正确评估与该手术相关的生活质量和累积费用,因此,评估晚期并发症和并发症至关重要。再入院率以及手术后较快康复的影响可能会影响患者的生活质量并恢复其积极的工作生活(这也对手术过程的社会成本产生了重要影响)。手术的经济和社会成本必须从成本效用和成本效益两方面进行调查,并且必须从不同的医疗保健系统的角度加以解决。由于必须有效分配医疗保健系统的经济资源,因此应将新手术方法(如MIDP)的完成视为全面实施新技术的基准。但是,MIDP的成本效益仍然不确定。几项研究的重点是开放式和腹腔镜DP(-)的成本比较,但关于机器人MIDP(r-MIDP)成本效益的数据很少,这通常带来更高的手术室成本(包括材料和手术时间相关因素)。从现在开始,只有三项研究着眼于开放式,腹腔镜式和机器人DP(-)的比较成本分析。一般而言,如Gavriilidis报道,与腹腔镜MIDP相比,机器人MIDP与住院时间减少1天相关。目前尚不清楚这种益处是否可以平衡与手术设备相关的r-MIDP的较高成本和更长的手术室时间。对卫生保健系统支持的总成本进行准确的评估是困难的,并且通常会因所衡量的不同结果和长期随访中的差异以及不同卫生保健系统的特殊性而产生偏差。 Rodriguez()最近发表的论文是为数不多的分析不同DP手术方法的经济影响和成本效益的研究之一。作者报告了在四年的时间内,连续两次在法国两家机构向DP提交了89例患者的报告。通过手术方法对患者进行分层:21例为机器人(RDP),25例为腹腔镜(LDP)和43例为开放手术(ODP)。机器人方法导致较低的术中失血量,可以提高脾脏的保存率,降低严重的发病率(Clavien-Dindo≥III级)。机器人方法与更长的手术时间和更长的手术室成本有关。有趣的是,r-MIDP手术的费用通过减少术后住院时间和降低需要额外治疗的严重术后并发症的发生率来抵消。因此,即使与腹腔镜检查相比,r-MIDP也是最经济的方法。在对结果进行更深入的分析时,必须考虑的是,三组患者中接受PDAC手术的患者百分比(发病率较高且由于肿瘤学原因而接受相关脾切除术的患者)差异很大(仅9.5%)。机器人组,而腹腔镜和开放组分别为32.5%和51.1%)。然而,罗德里格斯(Rodriguez)报告的结果不仅表明机器人方法的临床影响,而且还表明了降低MIDP机器人平台成本的潜力。

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