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LEOPARD 随机试验:微创与开放远端胰腺切除术的长期生活质量比较。

Long-Term Quality of Life after Minimally Invasive vs Open Distal Pancreatectomy in the LEOPARD Randomized Trial.

机构信息

Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, The Netherlands.

Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, The Netherlands; Department of Surgery, OLVG, Amsterdam, The Netherlands.

出版信息

J Am Coll Surg. 2021 Dec;233(6):730-739.e9. doi: 10.1016/j.jamcollsurg.2021.08.687. Epub 2021 Sep 13.

Abstract

BACKGROUND

Minimally invasive distal pancreatectomy (MIDP) shortens time to functional recovery and improves 30-day quality of life (QoL), as compared with open distal pancreatectomy (ODP) for nonmalignant disease. The impact of MIDP on QoL, cosmetic satisfaction, and overall major complications beyond 1-year follow-up is currently unknown.

STUDY DESIGN

The Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD) trial randomized 108 patients to MIDP (laparoscopic or robotic) or ODP in 14 Dutch centers (April 2015 to March 2017). The primary outcome measure of this study was quality-adjusted life years (QALYs), as assessed with the EQ-5D. QoL was assessed using subscales of the EORTC QLQ-C30, PAN-26, and a body image questionnaire. The latter included a cosmetic satisfaction score (range 3-24), and a body image score (range 5-20). Differences between MIDP and ODP for QALYs, generic, and disease-specific QoL and body image were analyzed. Missing QoL data were imputed using multiple imputation.

RESULTS

In total, 84 patients were alive, with a median follow-up of 44 months; 62 of these patients (74%) completed the questionnaires (27 MIDP, 35 ODP). There was no significant difference in QALYs between the 2 groups (mean score 2.34 vs 2.46 years, p = 0.63), nor on the QoL subscales. Significant overall change in EQ-5D health utilities were found for both groups over time (p < 0.001). Patients in the MIDP group scored higher on cosmetic satisfaction (21 vs 14, p = 0.049). No differences between the 2 groups were observed for clinical outcomes such as major complications, readmissions, and incisional hernias.

CONCLUSIONS

More than 3 years after distal pancreatectomy, no improvement in QALYs and overall QoL was seen after MIDP, whereas cosmetic satisfaction was higher after MIDP as compared with ODP.

摘要

背景

与开腹远端胰腺切除术(ODP)相比,微创远端胰腺切除术(MIDP)可缩短术后功能恢复时间并提高 30 天生活质量(QoL),适用于非恶性疾病。目前尚不清楚 MIDP 对 1 年以上随访时的 QoL、美容满意度和总体主要并发症的影响。

研究设计

微创与开腹远端胰腺切除术(LEOPARD)试验于 2015 年 4 月至 2017 年 3 月在 14 个荷兰中心将 108 例患者随机分配至 MIDP(腹腔镜或机器人)或 ODP 组。本研究的主要观察指标为质量调整生命年(QALYs),采用 EQ-5D 进行评估。使用 EORTC QLQ-C30、PAN-26 和身体形象问卷的子量表评估 QoL。后者包括美容满意度评分(范围 3-24)和身体形象评分(范围 5-20)。分析了 MIDP 和 ODP 在 QALYs、一般和疾病特异性 QoL 以及身体形象方面的差异。使用多重插补法填补缺失的 QoL 数据。

结果

共有 84 例患者存活,中位随访时间为 44 个月;其中 62 例患者(74%)完成了问卷调查(27 例 MIDP,35 例 ODP)。两组之间的 QALYs 没有显著差异(平均评分分别为 2.34 年和 2.46 年,p=0.63),QoL 子量表也没有差异。两组的 EQ-5D 健康效用随着时间的推移都有显著的总体变化(p<0.001)。MIDP 组患者的美容满意度评分更高(21 分比 14 分,p=0.049)。两组之间在主要并发症、再入院和切口疝等临床结局方面没有差异。

结论

远端胰腺切除术后 3 年以上,MIDP 并未改善 QALYs 和总体 QoL,而与 ODP 相比,MIDP 后美容满意度更高。

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