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抗凝治疗亚厘米息肉患者中持续抗凝与冷圈套息肉切除术对比肝素桥接与热圈套息肉切除术:一项随机对照试验。

Continuous Anticoagulation and Cold Snare Polypectomy Versus Heparin Bridging and Hot Snare Polypectomy in Patients on Anticoagulants With Subcentimeter Polyps: A Randomized Controlled Trial.

机构信息

Osaka International Cancer Institute, Osaka, Japan (Y.T.).

National Hospital Organization Hakodate National Hospital, Hakodate, Japan (K.M.).

出版信息

Ann Intern Med. 2019 Aug 20;171(4):229-237. doi: 10.7326/M19-0026. Epub 2019 Jul 16.

Abstract

BACKGROUND

Management of anticoagulants for patients undergoing polypectomy is still controversial. Cold snare polypectomy (CSP) is reported to cause less bleeding than hot snare polypectomy (HSP).

OBJECTIVE

To compare outcomes between continuous administration of anticoagulants (CA) with CSP (CA+CSP) and periprocedural heparin bridging (HB) with HSP (HB+HSP) for subcentimeter colorectal polyps.

DESIGN

Multicenter, parallel, noninferiority randomized controlled trial. (University Hospital Medical Information Network Clinical Trials Registry: UMIN000019355).

SETTING

30 Japanese institutions.

PATIENTS

Patients receiving anticoagulant therapy (warfarin or direct oral anticoagulants) who had at least 1 nonpedunculated subcentimeter colorectal polyp.

INTERVENTION

Patients were randomly assigned to undergo HB+HSP or CA+CSP and followed up 28 days after polypectomy.

MEASUREMENTS

The primary end point was incidence of polypectomy-related major bleeding (based on the incidence of poorly controlled intraprocedural bleeding or postpolypectomy bleeding requiring endoscopic hemostasis). The prespecified inferiority margin was -5% (CA+CSP vs. HB+HSP).

RESULTS

A total of 184 patients were enrolled: 90 in the HB+HSP group, 92 in the CA+CSP group, and 2 who declined to participate after enrollment. The incidence of polypectomy-related major bleeding in the HB+HSP and CA+CSP groups was 12.0% (95% CI, 5.0% to 19.1%) and 4.7% (CI, 0.2% to 9.2%), respectively. The intergroup difference for the primary end point was +7.3% (CI, -1.0% to 15.7%), with a 0.4% lower limit of 2-sided 90% CI, demonstrating the noninferiority of CA+CSP. The mean procedure time for each polyp and the hospitalization period were longer in the HB+HSP than in the CA+CSP group.

LIMITATION

An open-label trial assessing 2 factors (anticoagulation approach and polypectomy procedure type) simultaneously.

CONCLUSION

Patients having CA+CSP for subcentimeter colorectal polyps who were receiving oral anticoagulants did not have an increased incidence of polypectomy-related major bleeding, and procedure time and hospitalization were shorter than in those having HB+HSP.

PRIMARY FUNDING SOURCE

Japanese Gastroenterological Association.

摘要

背景

对于接受息肉切除术的患者,抗凝剂的管理仍存在争议。冷圈套息肉切除术(CSP)据报道比热圈套息肉切除术(HSP)引起的出血更少。

目的

比较持续给予抗凝剂(CA)联合 CSP(CA+CSP)与围手术期肝素桥接(HB)联合 HSP(HB+HSP)治疗亚厘米结直肠息肉的疗效。

设计

多中心、平行、非劣效性随机对照试验。(日本大学医院医学信息网络临床试验注册中心:UMIN000019355)。

地点

30 家日本机构。

患者

接受抗凝治疗(华法林或直接口服抗凝剂)且至少有 1 个非蒂状亚厘米结直肠息肉的患者。

干预

患者被随机分配接受 HB+HSP 或 CA+CSP,并在息肉切除后 28 天进行随访。

测量

主要终点为息肉切除术相关大出血的发生率(基于术中出血控制不佳或息肉切除后需要内镜止血的出血)。预设的劣势界限为-5%(CA+CSP 与 HB+HSP)。

结果

共纳入 184 例患者:HB+HSP 组 90 例,CA+CSP 组 92 例,2 例在入组后拒绝参与。HB+HSP 组和 CA+CSP 组息肉切除术相关大出血的发生率分别为 12.0%(95%CI,5.0%至 19.1%)和 4.7%(CI,0.2%至 9.2%)。主要终点的组间差异为+7.3%(CI,-1.0%至 15.7%),双侧 90%CI 的下限为 0.4%,表明 CA+CSP 的非劣效性。HB+HSP 组每个息肉的手术时间和住院时间均长于 CA+CSP 组。

局限性

同时评估了 2 个因素(抗凝治疗方法和息肉切除术类型)的开放性试验。

结论

对于接受口服抗凝剂的亚厘米结直肠息肉患者,给予 CA+CSP 不会增加息肉切除术相关大出血的发生率,并且手术时间和住院时间短于 HB+HSP。

主要资金来源

日本胃肠病学会。

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