Department of Internal Medicine, Pusan National University School of Medicine and Medical Research Institute, Beomeo-ri, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do, 626-770, South Korea.
Dig Dis Sci. 2011 Jul;56(7):2030-6. doi: 10.1007/s10620-011-1566-5. Epub 2011 Jan 25.
A self-expandable metal stent (SEMS) has emerged as an effective palliative treatment for malignant gastroduodenal obstruction resulting from gastric or periampullary malignancy. Despite the stent's effectiveness, tumor ingrowth and stent migration remain complications requiring reintervention. The purpose of this study was to evaluate the efficacy and safety of a double-layered SEMS (Comvi).
We performed a prospective multicenter study in two university hospitals and two referral hospitals. In fifty consecutive patients with malignant gastroduodenal obstructions, placement of double-layered SEMS, comprising an outer uncovered stent and an inner covered stent that overlap each other, was performed. Palliation, efficacy, and incidence of complications were evaluated.
Technical and clinical success was achieved in 100 and 88% of patients, respectively. There were no procedure-related complications. Five patients experienced stent migration (10%). For four of five patients' stent migration occurred within two weeks of stent placement. Stent collapse occurred in five patients after one month. Reintervention for stent migration, collapse, or tumor overgrowth was required for 14 (28%) patients.
Endoscopic placement of a double-layered stent is a safe and effective modality for the palliation of malignant gastroduodenal obstruction. However, considering reintervention, this stent does not seem to add any clear advantage compared with preexisting uncovered stents. Migration, especially within the first two weeks, and stent collapse are still unresolved problems. The device should be fixed or the design modified to reduce these problems.
自膨式金属支架（SEMS）已成为治疗因胃或胰周恶性肿瘤引起的恶性胃十二指肠梗阻的有效姑息治疗方法。尽管支架具有疗效，但肿瘤生长和支架迁移仍然是需要再次介入的并发症。本研究的目的是评估双层 SEMS（Comvi）的疗效和安全性。
我们在两所大学医院和两所转诊医院进行了一项前瞻性多中心研究。在 50 例恶性胃十二指肠梗阻患者中，放置了双层 SEMS，由一个外覆无盖支架和一个相互重叠的内覆支架组成。评估姑息治疗、疗效和并发症的发生率。
技术成功率和临床成功率分别为 100%和 88%。无手术相关并发症。5 例患者发生支架迁移（10%）。5 例患者中的 4 例在支架放置后两周内发生支架迁移。5 例患者在一个月后发生支架塌陷。14 例（28%）患者因支架迁移、塌陷或肿瘤过度生长需要再次介入治疗。
内镜下放置双层支架是治疗恶性胃十二指肠梗阻的一种安全有效的方法。然而，考虑到再次介入治疗，与现有的无盖支架相比，这种支架似乎没有明显的优势。迁移，尤其是在前两周内，以及支架塌陷仍然是未解决的问题。应固定该器械或修改设计以减少这些问题。
