Randomized Controlled Trial Comparing Radiologic Pigtail-Retained Gastrostomy and Radiologic Mushroom-Retained Gastrostomy

摘要

Abstract Purpose To prospectively compare 2 different types of percutaneous fluoroscopic gastrostomy procedures (pigtail-retained gastrostomy [PG] vs mushroom-retained gastrostomy [MG]). Materials and Methods Between March 2014 and February 2016, 100 patients were randomly assigned to receive 14-F PG or 20-F MG. Block randomization (block size 4) was performed, and sample size was calculated to assess the difference in minor complications. One patient withdrew from the study after allocation. Baseline characteristics were not significantly different between groups ( P > .05). Technical success, defined as successful placement of gastrostomy tube, and procedural complications were evaluated. Procedural complications were divided into major and minor complications according to the Society of Interventional Radiology criteria. Results Technical success rate was 100%. In the PG group, the major complication rate was 2% (1 of 50); 1 patient had a misplaced PG in the peritoneal cavity between the gastric and abdominal walls and developed peritonitis that had to be surgically treated. The minor complication rate was 34% (17 of 50) in the PG group. In the MG group, the major complication rate was 0%, and the minor complication rate was 12.2% (6 of 49). The most common minor complication was tube occlusion. Minor complication rate was significantly higher in the PG group ( P ?= .016). Mean fluoroscopy time was significantly longer in the MG group ( P ?= .013). Conclusions Both PG and MG demonstrated high technical success rates in all indications. MG had lower complication rates than PG at the cost of an increase in fluoroscopy times.