Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial.
Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial.
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DOI：
10.1001/jama.2016.2619
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发表时间：
2016-03-22
期刊：
影响因子：
--
通讯作者：
Sherman S
中科院分区：
文献类型：
--
作者：
Coté GA;Slivka A;Tarnasky P;Mullady DK;Elmunzer BJ;Elta G;Fogel E;Lehman G;McHenry L;Romagnuolo J;Menon S;Siddiqui UD;Watkins J;Lynch S;Denski C;Xu H;Sherman S
内窥镜下并行放置多个塑料支架是大多数良性胆管狭窄的一线治疗;全覆膜自膨式金属支架（cSEMS）可能需要较少的内窥镜逆行胰胆管造影术（ERCP）来解决问题。评估cSEMS在狭窄解决方面是否不劣于塑料支架。多中心（8家内镜转诊中心），开放标签、平行、随机临床试验，涉及原位肝移植（n = 73）、慢性胰腺炎（n = 35）或术后损伤（n = 4）导致的未经治疗的良性胆管狭窄（N = 112）患者，在2011年4月至2014年9月期间入组（随访至2015年10月结束）。排除胆管直径小于6 mm的患者和胆囊完整且胆囊管与cSEMS重叠的患者。患者（N = 112）随机接受多枚塑料支架或单枚cSEMS，按狭窄病因分层，每3个月（塑料支架）或每6个月（cSEMS）进行一次内镜再评估。狭窄消退后随访12个月，以评估复发情况。主要结局是内镜治疗不超过12个月后狭窄消退。样本量是根据cSEMS相对于塑料支架的非劣效性估计的，非劣效性界值为-15%。塑料支架组有55例患者（平均[SD]年龄，57 [11]岁; 17例女性[31%]），cSEMS组有57例患者（平均[SD]年龄，55 [10]岁; 19例女性[33%]）。与塑料支架（41/48，85.4%）相比，cSEMS的消退率为50/54例（92.6%），比率差异为7.2%（单侧95% CI，−3.0%至∞; P < .001）。鉴于预先规定的非劣效性界值为-15%，cSEMS不如塑料支架有效的零假设被拒绝。cSEMS组（2.14）与塑料组（3.24;平均差异，1.10; 95% CI，0.74 - 1.46; P <0.001）相比，达到消退的ERCP平均数量较低。在胆管直径≥ 6 mm且覆膜金属支架不会与胆囊管重叠的良性胆管狭窄患者中，cSEMS在12个月后实现狭窄消退方面不劣于多个塑料支架。金属支架应被视为此类患者的适当选择。clinicaltrials.gov标识符：NCT 01221311
Endoscopic placement of multiple plastic stents in parallel is the first-line treatment for most benign biliary strictures; it is possible that fully covered, self-expandable metallic stents (cSEMS) may require fewer endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution. To assess whether use of cSEMS is noninferior to plastic stents with respect to stricture resolution. Multicenter (8 endoscopic referral centers), open-label, parallel, randomized clinical trial involving patients with treatment-naive, benign biliary strictures (N = 112) due to orthotopic liver transplant (n = 73), chronic pancreatitis (n = 35), or postoperative injury (n = 4), who were enrolled between April 2011 and September 2014 (with follow-up ending October 2015). Patients with a bile duct diameter less than 6 mm and those with an intact gallbladder in whom the cystic duct would be overlapped by a cSEMS were excluded. Patients (N = 112) were randomized to receive multiple plastic stents or a single cSEMS, stratified by stricture etiology and with endoscopic reassessment for resolution every 3 months (plastic stents) or every 6 months (cSEMS). Patients were followed up for 12 months after stricture resolution to assess for recurrence. Primary outcome was stricture resolution after no more than 12 months of endoscopic therapy. The sample size was estimated based on the noninferiority of cSEMS to plastic stents, with a noninferiority margin of −15%. There were 55 patients in the plastic stent group (mean [SD] age, 57 [11] years; 17 women [31%]) and 57 patients in the cSEMS group (mean [SD] age, 55 [10] years; 19 women [33%]). Compared with plastic stents (41/48, 85.4%), the cSEMS resolution rate was 50 of 54 patients (92.6%), with a rate difference of 7.2% (1-sided 95% CI, −3.0% to ∞; P < .001). Given the prespecified noninferiority margin of −15%, the null hypothesis that cSEMS is less effective than plastic stents was rejected. The mean number of ERCPs to achieve resolution was lower for cSEMS (2.14) vs plastic (3.24; mean difference, 1.10; 95% CI, 0.74 to 1.46; P < .001). Among patients with benign biliary strictures and a bile duct diameter 6 mm or more in whom the covered metallic stent would not overlap the cystic duct, cSEMS were not inferior to multiple plastic stents after 12 months in achieving stricture resolution. Metallic stents should be considered an appropriate option in patients such as these. clinicaltrials.gov Identifier: NCT01221311
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影响因子：
19.7
作者：
ROSSI, P;BEZZI, M;PORCARO, ML
通讯作者：
PORCARO, ML
影响因子：
9.3
作者：
Haapamaki, Carola;Kylanpaa, Leena;Halttunen, Jorma
通讯作者：
Halttunen, Jorma
DOI：
10.1136/bmj.c2697
发表时间：
2010-06-14
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Abraha I;Montedori A
通讯作者：
Montedori A
影响因子：
9.3
作者：
van Berkel, AM;Cahen, DL;Bruno, MJ
通讯作者：
Bruno, MJ
影响因子：
7.7
作者：
Walter, Daisy;Laleman, Wim;Siersema, Peter D.
通讯作者：
Siersema, Peter D.