Wagner H J, Stinner B, Schwerk W B, Hoppe M, Klose K J
Department of Diagnostic Radiology, University Hospital, Philipps University, Marburg, Germany.
J Vasc Interv Radiol. 1994 Nov-Dec;5(6):899-904. doi: 10.1016/s1051-0443(94)71634-1.
This uncontrolled prospective study was undertaken to evaluate a new nitinol stent in the treatment of dysphagia due to inoperable malignant esophageal obstruction.
Eighteen consecutive patients (15 men, three women; mean age, 66 years +/- 15) with inoperable malignant obstructions of the esophagus or esophagogastric junction due to esophageal carcinoma (n = 14) or extrinsic obstruction (n = 4) were treated with self-expanding nitinol endoprostheses (diameter, 18 mm). Dysphagia score and activity index were assessed before and every 4 weeks after stent insertion.
Eighteen stents were deployed successfully. One stent expanded insufficiently and was removed inadvertently during retrieval of the application system. Mean time until complete expansion of the stent was 7.1 days +/- 5. Stent placement resulted in a significant decrease in the dysphagia score (2.7 +/- 0.7 before vs 0.6 +/- 0.7 after stent placement, P < .00005 by Wilcoxon matched-pairs test) and a significant increase in the activity index (2.6 +/- 1 before vs 1.7 +/- 0.9 after stent insertion; P < .005). There were no procedure-related complications. Follow-up period (mean, 155 days +/- 100) revealed recurrent dysphagia in four patients. Two patients experienced food bolus impaction, another two had tumor ingrowth through the mesh after 170 and 186 days. Fourteen patients died after a mean survival time of 158 days +/- 106, all with patent stents.
Self-expanding nitinol esophageal stents are safe and effective in the treatment of malignant esophageal obstructions.
开展这项非对照前瞻性研究，以评估一种新型镍钛合金支架治疗因无法手术的恶性食管梗阻所致吞咽困难的效果。
连续18例患者（15例男性，3例女性；平均年龄66岁±15岁），因食管癌（n = 14）或外在梗阻（n = 4）导致食管或食管胃交界处出现无法手术的恶性梗阻，接受了自膨式镍钛合金内支架（直径18 mm）治疗。在支架置入前及置入后每4周评估吞咽困难评分和活动指数。
成功置入18枚支架。1枚支架扩张不充分，在回收应用系统时被意外取出。支架完全扩张的平均时间为7.1天±5天。支架置入使吞咽困难评分显著降低（置入支架前为2.7±0.7，置入后为0.6±0.7，Wilcoxon配对检验P <.00005），活动指数显著升高（置入支架前为2.6±1，置入后为1.7±0.9；P <.005）。未发生与操作相关的并发症。随访期（平均155天±100天）发现4例患者出现复发性吞咽困难。2例患者发生食物团块嵌塞，另外2例在170天和186天后出现肿瘤长入网孔。14例患者在平均生存时间158天±106天后死亡，所有患者的支架均通畅。
自膨式镍钛合金食管支架治疗恶性食管梗阻安全有效。
