Randomized Controlled Trial of Percutaneous Radiologic Gastrostomy Performed With and Without Gastropexy: Technical Success, Patient-Reported Outcomes and Safety.

PURPOSE

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.

MATERIALS AND METHODS

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.

RESULTS

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 One non-gastropexy patient was withdrawn from the study due to failed insertion.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).

CONCLUSION

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 OF EVIDENCE

Level 2, randomized trial.