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确定 CROSS0 组、CROSS1 或 2 组患者中行自膨式金属支架桥接手术治疗梗阻性结肠癌的疗效和安全性差异:来自两项日本前瞻性多中心试验的数据汇总分析。

Determining the difference in the efficacy and safety of self-expandable metallic stents as a bridge to surgery for obstructive colon cancer among patients in the CROSS 0 group and those in the CROSS 1 or 2 group: a pooled analysis of data from two Japanese prospective multicenter trials.

机构信息

Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.

Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.

出版信息

Surg Today. 2020 Sep;50(9):984-994. doi: 10.1007/s00595-020-01970-3. Epub 2020 Feb 6.

Abstract

PURPOSE

This study compared the feasibility and safety of endoscopic placement of self-expandable metallic stents (SEMSs) as a bridge to surgery (BTS) between patients with obstructive colorectal cancer (CRC) classified as ColoRectal Obstruction Scoring System (CROSS) 0 and those with CROSS 1 or 2.

METHODS

We conducted a post hoc analysis of two prospective, observational, single-arm multicenter clinical trials and performed a pooled analysis of the data. In total, 336 consecutive patients with malignant colorectal obstruction underwent SEMS placement. The primary endpoint was clinical success, defined as resolution of symptoms and radiological findings within 24 h. Secondary endpoints were technical success and adverse events.

RESULTS

High clinical (98.0% vs. 98.4%) and technical (96.7% vs. 97.8%) success rates were observed in both groups (CROSS 0 vs. CROSS 1 or 2). The adverse event rate was low. The mean stricture length was lower (3.8 ± 1.2 cm vs. 4.4 ± 1.8 cm) and laparoscopic surgery more common (56.7% vs 52.2%) in the CROSS 0 group than in the CROSS 1 and 2 group.

CONCLUSION

This study was the first to compare the degree of stricture in different CROSS groups and demonstrated comparable results with respect to the short-term efficacy and safety of SEMS placement as a BTS for obstructive CRC in CROSS 0, 1, and 2 patients.

摘要

目的

本研究比较了 CROSS 评分系统(ColoRectal Obstruction Scoring System)0 分和 1 分或 2 分的梗阻性结直肠癌(CRC)患者中,内镜下放置自膨式金属支架(SEMS)作为手术桥接(BTS)的可行性和安全性。

方法

我们对两项前瞻性、观察性、单臂多中心临床试验进行了事后分析,并对数据进行了汇总分析。共有 336 例恶性结直肠梗阻患者接受了 SEMS 放置。主要终点是临床成功率,定义为 24 小时内症状和影像学发现得到缓解。次要终点是技术成功率和不良事件。

结果

两组的临床成功率(98.0% vs. 98.4%)和技术成功率(96.7% vs. 97.8%)均较高。不良事件发生率较低。CROSS 0 组的平均狭窄长度较低(3.8±1.2cm vs. 4.4±1.8cm),腹腔镜手术更为常见(56.7% vs 52.2%)。

结论

本研究首次比较了不同 CROSS 组的狭窄程度,并证明了在 CROSS 0、1 和 2 组患者中,SEMS 放置作为梗阻性 CRC 的 BTS 的短期疗效和安全性相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/53b4/7441084/3ebc3a6bbb2b/595_2020_1970_Fig1_HTML.jpg

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