Endoscopic pyloric injection of botulinum toxin-A for the treatment of postvagotomy gastroparesis

OBJECTIVES: To evaluate the efficacy of botulinum toxin-A in the treatment of postvagotomy gastroparesis. METHODS: This open-labeled trial identified and recruited 11 subjects who developed symptomatic gastroparesis after a vagotomy (9 fundoplication, 1 trauma, and 1 exploratory laparotomy). Gastroparesis was defined as an abnormal solid-phase gastric emptying test using the standardized 4-hour radionuclide eggbeater meal method and vagotomy was confirmed with a sham meal challenge test. To complete the study, subjects should have completed the 6-month follow-up visit after their pylorus was injected with botulinum toxin-A injection in a 4-quadrant manner. Patients either received 100 (n = 2) or 200 (n = 9) units of botulinum toxin. Questionnaires recorded symptom severity of gastroparesis at baseline and at monthly intervals for 6 months after the therapy was completed by the patients. RESULTS: Of the 11 subjects initially recruited, 10 finished the 6-month follow-up visit (7 women). Mean age was 51 years (range, 31-84 years). Mean symptom score at baseline was 16 (95% CI 13-19) and showed a numerical decline to 9 (P > 0.05) over the 6-month period after the procedure (95% CI 5-13). Seven (70%) patients observed >30% improvement in the total symptom score. No complications were recorded. CONCLUSIONS: In conclusion, this open-label study in patients with postvagotomy gastroparesis patients reveals a reduction of gastroparetic symptoms at 1 and 3 months after treatment with pyloric injection of botulinum toxin-A, with return of symptoms by 6 months. Thus, botulinum toxin treatment does not produce a sustained reduction in gastroparetic symptoms in this clinical setting.