Randomized Trial Comparing Radiologic Pigtail Gastrostomy and Peroral Image-Guided Gastrostomy: Intra- and Postprocedural Pain, Radiation Exposure, Complications, and Quality of Life.

Purpose: To prospectively compare radiologically created pigtail gastrostomy (PG), in which the tube is inserted directly through the abdominal wall, versus peroral image-guided gastrostomy (POG), in which the tube is inserted through the mouth. Pain profiles (primary outcome measure), fluoroscopy times, total room times, technical success, complications, and quality of life (QOL) were measured.

Materials And Methods: Sixty patients were prospectively randomized to receive 14-F PG or 20-F POG tubes. All patients received prophylactically created gastrostomies before radiation therapy for head and neck squamous-cell carcinoma. Patients receiving palliative treatment were excluded, as were those with established pharyngeal obstruction. Pain was measured by numeric rating scale (NRS) scores for 6 weeks after the procedure and by intraprocedural fentanyl and midazolam doses and postprocedural 24-h morphine doses. Fluoroscopy times, total room times, technical success, complications up to 6 months, and gastrostomy-related QOL (using the Functional Assessment of Cancer Therapy-Enteral Feeding questionnaire) were determined.

Results: Fifty-six patients underwent the randomized procedure. The POG group required significantly higher intraprocedural midazolam and fentanyl doses (mean, 1.2 mg and 67 μg, respectively, for PG vs 1.9 mg and 105 μg for POG; P < .001) and had significantly longer fluoroscopy times (mean, 1.3 min for PG vs 4.8 min for POG; P < .0001). NRS scores, morphine doses, total room times, technical success, complication rates, and QOL did not differ significantly between groups. The one major complication, a misplaced PG in the peritoneal cavity, followed a technical failure of POG creation.

Conclusions: Despite the differences in insertion technique and tube caliber, the measured outcomes of POG and PG are comparable.