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恶性胆管梗阻中在Oddi括约肌上方及跨越该括约肌放置支架的随机试验

Randomized trial of stent placed above and across the sphincter of Oddi in malignant bile duct obstruction.

作者信息

Pedersen F M, Lassen A T, Schaffalitzky de Muckadell O B

机构信息

Department of Medical Gastroenterology, Odense University Hospital, 5000 Odense, Denmark.

出版信息

Gastrointest Endosc. 1998 Dec;48(6):574-9. doi: 10.1016/s0016-5107(98)70038-0.

DOI:10.1016/s0016-5107(98)70038-0
PMID:9852446
Abstract

BACKGROUND

Placement of stents above an intact sphincter of Oddi might prevent migration of bacteria and deposition of organic material into the stent. In patients with malignant obstructive jaundice prolongation of function time of the stent would be expected if it is placed above the sphincter of Oddi.

METHODS

Thirty-four patients were randomized to stent placement either above (n = 17) or across (n = 17) the sphincter of Oddi. Straight 10F gauge Teflon stents were used. The patients were evaluated clinically and biochemically at monthly intervals during follow-up.

RESULTS

The median stent function time (i.e., the time from insertion of the stent until stent replacement, patient death, or study termination) were 110 days (25th to 75th percentiles, 61 to 320 days) for stents placed above the sphincter of Oddi and 126 days (25th to 75th percentiles, 89 to 175 days) for stents placed across the sphincter of Oddi (nonsignificant [NS]). Stent replacement rates were 58.8% (10 of 17) in patients with stents placed above the sphincter and 29.4% (5 of 17) in patients with stents placed across the sphincter (NS). Significantly more patients in the former group experienced stent migration (9 vs. 2, p = 0.026). The median time from stent insertion until replacement of the stents placed above and across the sphincter of Oddi were 82 days (25th to 75th percentiles, 31 to 185 days) and 89 days (25th to 75th percentiles, 13 to 150 days), respectively (NS).

CONCLUSIONS

No significant difference in overall stent performance between the two groups was found, although more stents placed above the sphincter of Oddi migrated. The time until dysfunction of the stent might be increased if migration of stents placed inside the common bile duct could be avoided.

摘要

背景

在完整的Oddi括约肌上方放置支架可能会防止细菌迁移和有机物质在支架内沉积。对于恶性梗阻性黄疸患者,如果将支架放置在Oddi括约肌上方,预计支架功能时间会延长。

方法

34例患者被随机分为两组,分别在Oddi括约肌上方(n = 17)或穿过Oddi括约肌(n = 17)放置支架。使用直的10F规格的聚四氟乙烯支架。在随访期间,每月对患者进行临床和生化评估。

结果

Oddi括约肌上方放置的支架的中位支架功能时间(即从支架置入到支架更换、患者死亡或研究终止的时间)为110天(第25至75百分位数,61至320天),穿过Oddi括约肌放置的支架的中位支架功能时间为126天(第25至75百分位数,89至175天)(无显著性差异[NS])。Oddi括约肌上方放置支架的患者的支架更换率为58.8%(17例中的10例),穿过Oddi括约肌放置支架的患者的支架更换率为29.4%(17例中的5例)(无显著性差异)。前一组中有更多患者经历了支架迁移(9例对2例,p = 0.026)。Oddi括约肌上方和穿过Oddi括约肌放置的支架从置入到更换的中位时间分别为82天(第25至75百分位数,31至185天)和89天(第25至75百分位数,13至150天)(无显著性差异)。

结论

尽管Oddi括约肌上方放置的更多支架发生了迁移,但两组之间在总体支架性能方面未发现显著差异。如果能够避免胆总管内放置的支架发生迁移,支架功能障碍的时间可能会延长。

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