Division of Interventional Radiology, Joint Department of Medical Imaging, Toronto General Hospital, University of Toronto, 585 University Ave, Toronto, ON, M5G 2N2, Canada.
Cardiovasc Intervent Radiol. 2021 Jul;44(7):1081-1088. doi: 10.1007/s00270-021-02806-4. Epub 2021 Mar 11.
The aim of this study is to compare balloon-retention percutaneous radiologic gastrostomy (PRG) tube insertion performed with and without gastropexy, primarily focusing on pain and patient-reported outcomes.
Research ethics board approved a dual-arm, single-centre, randomized trial of 60 patients undergoing primary 14-French PRG tube insertion (NCT04107974). Patients were randomized to receive either PRG with gastropexy or without gastropexy. Data were collected for technical outcomes, patient-reported outcomes pre-procedure, post-procedure and at 1-month, as well as quality of life parameters at 1-month post-procedure (EQ5D-5L, Visual Analogue Scale and Functional Assessment of Cancer Therapy-Enteral Feeding questionnaires). Complications occurring up to 6-months post-procedure were recorded.
Sixty patients were randomized to the gastropexy group (n = 30) or non-gastropexy (n = 30) group. One non-gastropexy patient was withdrawn from the study due to failed insertion. PRG procedural time was significantly longer when using gastropexy (mean 11.4 ± 7.19 min) compared with non-gastropexy (mean 6.79 ± 4.63 min; p < 0.05). Pain scores did not differ between the two groups pre-procedure, post-procedure and at 1-month follow-up, nor did 1-month quality of life parameters. Six (20%) minor complications occurred in the gastropexy group and nine (31%) minor complications in the non-gastropexy group (p = 0.330). Two (6.9%) major complications occurred in the non-gastropexy group (p = 0.458).
There is comparable patient tolerability when balloon-retention PRG insertion is performed with or without gastropexy sutures. This study also demonstrated a trend towards fewer complications when gastropexy is utilized. However, further larger trials are required to compare complications of the two approaches for PRG insertion.
Level 2, randomized trial.
本研究旨在比较带和不带胃固定术的球囊留置经皮胃造瘘术（PRG）管插入，主要关注疼痛和患者报告的结果。
研究伦理委员会批准了一项 60 例患者行初次 14-French PRG 管插入的双臂、单中心、随机试验（NCT04107974）。患者随机接受 PRG 联合胃固定术或不联合胃固定术。收集技术结果、术前、术后和 1 个月的患者报告结果，以及术后 1 个月的生活质量参数（EQ5D-5L、视觉模拟量表和癌症治疗-肠内喂养功能评估问卷）。记录至术后 6 个月的并发症。
60 例患者被随机分为胃固定术组（n=30）或非胃固定术组（n=30）。1 例非胃固定术患者因插入失败退出研究。使用胃固定术的 PRG 手术时间明显长于非胃固定术（平均 11.4±7.19 分钟）（p<0.05）。两组患者术前、术后和 1 个月随访时疼痛评分无差异，1 个月生活质量参数也无差异。胃固定术组发生 6 例（20%）轻微并发症，非胃固定术组发生 9 例（31%）轻微并发症（p=0.330）。非胃固定术组发生 2 例（6.9%）严重并发症（p=0.458）。
带或不带胃固定术的球囊留置 PRG 插入术患者耐受性相当。本研究还表明，使用胃固定术时并发症的趋势更少。然而，需要进一步的大型试验来比较两种 PRG 插入方法的并发症。
2 级，随机试验。
