Academic Medical Center, University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, the Netherlands.
Surg Endosc. 2010 Jun;24(6):1387-97. doi: 10.1007/s00464-009-0784-9. Epub 2010 Mar 3.
This study aimed to assess whether endoscopic implantation of an injectable esophageal prosthesis, the Gatekeeper Reflux Repair System (GK), is a safe and effective therapy for controlling gastroesophageal reflux disease (GERD).
A prospective, randomized, sham-controlled, single-blinded, international multicenter study planned final enrollment of 204 patients in three groups: up to 60 lead-in, 96 GK, and 48 sham patients. The sham patients were allowed to cross over to the GK treatment arm or exit the study at 6 months. The primary end points were (1) reduction in serious device- and procedure-related adverse device effects compared with a surgical composite complication rate and (2) reduction in heartburn symptoms 6 months after the GK procedure compared with the sham procedure. The secondary end point was improved esophageal pH (total time pH was <4) 6 months after the GK procedure compared with baseline.
A planned interim analysis was performed after 143 patients were enrolled (25 lead-in, 75 GK, and 43 sham patients), and the GK study was terminated early due to lack of compelling efficacy data. Four reported serious adverse events had occurred (2 perforations, 1 pulmonary infiltrate related to a perforation, and 1 severe chest pain) at termination of the study with no mortality or long-term sequelae. Heartburn symptoms had improved significantly at 6 months compared with baseline in the GK group (p < 0.0001) and the sham group (p < 0.0001), but no significant between-group difference in improvement was observed (p = 0.146). Esophageal acid exposure had improved significantly at 6 months compared with baseline in the GK group (p = 0.021) and the sham group (p = 0.003), but no significant between-group difference in improvement was observed (p = 0.27).
The GK procedure was associated with some serious but infrequent complications. No statistically significant difference in outcomes was observed between the treatment and control groups at 6 months compared with baseline.
本研究旨在评估内镜下植入可注射食管假体（GK）Gatekeeper 反流修复系统是否是控制胃食管反流病（GERD）的一种安全有效的治疗方法。
一项前瞻性、随机、假对照、单盲、国际多中心研究，计划最终纳入三组 204 例患者：60 例导入期、96 例 GK 组和 48 例假手术组。假手术组允许在 6 个月时交叉到 GK 治疗组或退出研究。主要终点是（1）与手术复合并发症率相比，严重器械相关不良器械相关不良事件的减少；（2）与假手术相比，GK 术后 6 个月烧心症状的改善。次要终点是与基线相比，GK 术后 6 个月食管 pH（总时间 pH <4）的改善。
在纳入 143 例患者（25 例导入期、75 例 GK 组和 43 例假手术组）后进行了计划的中期分析，并由于缺乏令人信服的疗效数据，提前终止了 GK 研究。研究结束时，有 4 例报告发生严重不良事件（2 例穿孔、1 例与穿孔相关的肺部浸润和 1 例严重胸痛），但无死亡或长期后遗症。与基线相比，GK 组（p < 0.0001）和假手术组（p < 0.0001）在 6 个月时烧心症状均显著改善，但两组间改善无显著差异（p = 0.146）。与基线相比，GK 组（p = 0.021）和假手术组（p = 0.003）在 6 个月时食管酸暴露均显著改善，但两组间改善无显著差异（p = 0.27）。
GK 术式相关的严重但罕见的并发症。与基线相比，治疗组和对照组在 6 个月时的结局无统计学显著差异。
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