预防性夹闭在预防侧向扩展结直肠病变的广域内镜黏膜切除术后出血中的作用：一项经济建模研究。
Prophylactic clipping for the prevention of bleeding following wide-field endoscopic mucosal resection of laterally spreading colorectal lesions: an economic modeling study.
机构信息
Department of Gastroenterology and Hepatology, Westmead Hospital, Westmead, New South Wales, Australia.
出版信息
Endoscopy. 2016 Aug;48(8):754-61. doi: 10.1055/s-0042-105558. Epub 2016 Apr 25.
BACKGROUND AND STUDY AIMS
Clinically significant bleeding (CSPEB) is the most common adverse event following endoscopic mucosal resection (EMR) of large sessile and laterally spreading colorectal lesions (LSLs), and is associated with morbidity and resource utilization. CSPEB occurs more frequently with proximal LSLs. Prophylactic clipping of the post-EMR defect may be beneficial in CSPEB prevention. The aim of this study was to determine the cost-effectiveness of a prophylactic clipping strategy. We hypothesized that prophylactic clipping in the proximal colon was cost-effective.
PATIENTS AND METHODS
An economic model was applied to outcomes from the Australian Colonic Endoscopic Mucosal Resection (ACE) Study. Clip distances of 3, 5, 8, and 10 mm were analyzed. The cost of treating CSPEB was determined from an independent costing agency. The funds needed to spend (FNS) was the cost incurred in order to prevent one episode of CSPEB. A break-even analysis was performed to determine cost equivalence of the costs of clipping and CSPEB.
RESULTS
Outcomes of 1717 LSLs (mean size 35.8 mm; 52.6 % proximal colon) that underwent EMR were analyzed. The overall rate of CSPEB was 6.4 % (proximal 8.9 %; distal 3.7 %). Endoscopic management was required in 45 % of CSPEB episodes. With a clip distance of 3 mm, the expected cost of prophylactic clipping was € 1106 per lesion compared with € 157 per lesion for the expected cost of CSPEB without clipping. At 100 % clipping efficacy, the FNS was € 14 826 (proximal and distal lesions € 9309 and € 29 540, respectively). A clip price of € 10.35 was required for the cost of clipping to offset the cost of CSPEB.
CONCLUSIONS
A prophylactic clipping strategy is not cost-effective and at present cannot be justified for all lesions or selectively for lesions in the proximal colon.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT01368289).
背景和研究目的
内镜下黏膜切除术（EMR）后，临床显著出血（CSPEB）是最大的常见不良事件，与发病率和资源利用相关。CSPEB 在近端侧向扩张性大肠病变（LSL）中更常见。EMR 后缺损预防性夹闭可能有利于 CSPEB 的预防。本研究旨在确定预防性夹闭策略的成本效益。我们假设近端结肠预防性夹闭具有成本效益。
患者和方法
应用经济模型分析澳大利亚结肠内镜黏膜切除术（ACE）研究的结果。分析夹距为 3、5、8 和 10mm。通过独立的成本核算机构确定 CSPEB 的治疗成本。预防一次 CSPEB 所需的资金（FNS）是为了预防 CSPEB 而产生的成本。进行盈亏平衡分析以确定夹闭和 CSPEB 的成本等效性。
结果
分析了 1717 例 LSLs（平均大小 35.8mm；52.6%位于近端结肠）的 EMR 结果。CSPEB 的总体发生率为 6.4%（近端为 8.9%；远端为 3.7%）。CSPEB 事件中有 45%需要内镜治疗。夹距为 3mm 时，预防性夹闭的预期成本为每例病变 1106 欧元，而不夹闭的 CSPEB 预期成本为每例病变 157 欧元。在 100%夹闭效果下，FNS 为 14826 欧元（近端和远端病变分别为 9309 欧元和 29540 欧元）。夹闭的价格需要为 10.35 欧元，才能抵消 CSPEB 的成本。
结论
预防性夹闭策略没有成本效益，目前不能为所有病变或仅为近端病变提供合理性。
试验注册
ClinicalTrials.gov（NCT01368289）。
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