Ell C, Hochberger J, May A, Fleig W E, Hahn E G
Department of Medicine I, University of Erlangen-Nuremberg, Germany.
Am J Gastroenterol. 1994 Sep;89(9):1496-500.
The clinical feasibility of self-expanding metal stents with respect to the technical success, complications, and reintervention rate should be tested.
Five coated and 26 uncoated prototype Wallstents, especially designed for stenosis of the upper GI tract, were implanted in 23 patients. All patients with dysphagia suffered from inoperable tumor stenosis of the esophagus or the cardia. Stent implantation was performed under slight i.v. sedoanalgesia.
Technical success was achieved in all 31 implanted stents. Forty-eight hr after implantation, dysphagia was improved in 21/23 patients. Acute problems observed within 1 wk were stent migration (1 patient, uncoated stent), oblique position of the stent (3 patients), epigastric or retrosternal pain (9 patients), insufficient stent expansion (4 patients), and pouch formation at the upper rim of the stent (4 patients). An uncomplicated follow-up (median 66 days, range 10-139 days) was seen in 12 patients (52%). Major problems in the follow-up period were stent migration in three patients (three coated stents, two stent migrations in one patient) and stent obstruction by tumor ingrowth/overgrowth and/or food impaction in eight patients (35%). Most of these problems could be successfully resolved by implantation of a second stent or electrocoagulation of overgrowing tumor tissue. By the 1st of March, 1994, three patients were still alive with a follow-up period of 530 days (median range, 336-880 days); 20 patients were decreased with a follow-up period of 70 days (median range, 3-374 days).
Implantation of esophageal Wallstents is safe and has a low risk of acute complications and mortality for the patient. Early complications such as perforation and bleeding did not occur. Tumor ingrowth/overgrowth are the major reasons for the high reintervention rate in the follow-up period. Coated stents can resolve this problem, provided that stent migration can be avoided by improvement of the coating technology.
应测试自膨式金属支架在上消化道狭窄治疗中的技术成功率、并发症及再次干预率方面的临床可行性。
将5个带涂层和26个未带涂层的专门设计用于上消化道狭窄的原型Wallstent支架植入23例患者体内。所有吞咽困难患者均患有无法手术切除的食管或贲门肿瘤狭窄。支架植入在轻度静脉镇静镇痛下进行。
31个植入的支架均取得技术成功。植入后48小时，21/23例患者的吞咽困难得到改善。1周内观察到的急性问题有支架移位（1例，未带涂层支架）、支架倾斜（3例）、上腹部或胸骨后疼痛（9例）、支架扩张不足（4例）以及支架上缘袋状形成（4例）。12例患者（52%）随访过程顺利（中位时间66天，范围10 - 139天）。随访期间的主要问题是3例患者发生支架移位（3个带涂层支架，1例患者发生2次支架移位）以及8例患者（35%）出现肿瘤长入/过度生长和/或食物嵌塞导致的支架阻塞。这些问题大多可通过植入第二个支架或对过度生长的肿瘤组织进行电凝来成功解决。到1994年3月1日，3例患者仍存活，随访期为530天（中位范围，336 - 880天）；20例患者死亡，随访期为70天（中位范围，3 - 374天）。
食管Wallstent支架植入对患者而言是安全的，急性并发症和死亡率风险较低。未发生穿孔和出血等早期并发症。肿瘤长入/过度生长是随访期间再次干预率高的主要原因。带涂层支架可以解决这个问题，前提是通过改进涂层技术避免支架移位。
