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多中心临床试验评估覆盖自膨式金属支架在良性胆道狭窄中的应用:是否需要重新考虑我们的治疗选择?

Multicenter trial evaluating the use of covered self-expanding metal stents in benign biliary strictures: time to revisit our therapeutic options?

机构信息

Weill Cornell Medical Center, New York, NY, USA.

出版信息

J Clin Gastroenterol. 2013 Sep;47(8):695-9. doi: 10.1097/MCG.0b013e31827fd311.

DOI:10.1097/MCG.0b013e31827fd311
PMID:23442836
Abstract

BACKGROUND

Covered self-expanding metal stents are being used more frequently in benign biliary strictures (BBS). We report the results of a multicenter study with fully covered self-expanding metal stent (FCSEMS) placement for the management of BBS.

AIM

: To prospectively evaluate the efficacy and safety of FCSEMS in the management of BBS.

PATIENTS AND METHODS

Patients with BBS from 6 tertiary care centers who received FCSEMS with flared ends between April 2009 and October 2010 were included in this retrospective study.Efficacy was measured after removal of FCSEMS by evaluating stricture resolution on the basis of symptom resolution, imaging, laboratory studies, and/or choledochoscopy at removal. Safety profile was evaluated by assessing postprocedural complications.

RESULTS

A total of 133 patients (78, 58.6% males) with a mean age of 59.2±14.8 years with BBS received stents. Of the 133 stents placed, 97 (72.9%) were removed after a mean stent duration of 95.5±48.7 days. Stricture resolution after FCSEMS removal was as follows: postsurgical, 11/12 (91.6%); gallstone-related disease, 16/19 (84.2%); chronic pancreatitis, 26/31 (80.7%); other etiology, 4/5 (80.0%); and anastomotic strictures, 19/31(61.2%). Ninety-four patients were included in the logistic regression analyses. Patients who had indwelling stents for >90 days were 4.3 times more likely to have resolved strictures [odds ratio, 4.3 (95% confidence interval, 1.24-15.09)] and patients with nonmigrated stents were 5.4 times more likely to have resolved strictures [odds ratio, 5.4 (95% confidence interval, 1.001-29.29)].

CONCLUSIONS

FCSEMS for BBS had an acceptable rate of stricture resolution for postsurgical strictures, gallstone-related strictures, and those due to chronic pancreatitis. Predictors for stricture resolution include longer indwell time and absence of migration. Further study is warranted to assess long-term efficacy in a prospective manner with longer than 3-month time of stent indwelling time.

摘要

背景

覆膜自膨式金属支架在良性胆道狭窄(BBS)中的应用越来越多。我们报告了一项多中心研究的结果,该研究使用完全覆膜自膨式金属支架(FCSEMS)治疗 BBS。

目的

前瞻性评估 FCSEMS 在 BBS 管理中的疗效和安全性。

患者和方法

2009 年 4 月至 2010 年 10 月,来自 6 家三级护理中心的 BBS 患者接受 FCSEMS 治疗,支架末端呈喇叭形。支架取出后,根据症状缓解、影像学、实验室研究和/或取石时胆管镜检查评估狭窄缓解情况来评估疗效。通过评估术后并发症评估安全性。

结果

共 133 例(78 例,58.6%为男性)BBS 患者接受支架治疗,平均年龄 59.2±14.8 岁。133 个支架中,97 个(72.9%)在平均支架持续时间 95.5±48.7 天后取出。FCSEMS 取出后狭窄缓解情况如下:术后狭窄 11/12(91.6%);胆石症相关疾病 16/19(84.2%);慢性胰腺炎 26/31(80.7%);其他病因 4/5(80.0%);吻合口狭窄 19/31(61.2%)。94 例患者纳入逻辑回归分析。支架留置时间>90 天的患者狭窄缓解的可能性是支架留置时间<90 天患者的 4.3 倍[比值比,4.3(95%置信区间,1.24-15.09)];支架未迁移的患者狭窄缓解的可能性是支架迁移患者的 5.4 倍[比值比,5.4(95%置信区间,1.001-29.29)]。

结论

FCSEMS 治疗 BBS 术后狭窄、胆石症相关狭窄和慢性胰腺炎引起的狭窄,狭窄缓解率可接受。狭窄缓解的预测因素包括较长的留置时间和无迁移。需要进一步研究,前瞻性地评估更长时间(支架留置时间>3 个月)的长期疗效。

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