This randomized phase II trial studies how well botulinum toxin type A works in preventing complication after surgery in patients with esophageal cancer. Botulinum toxin type A may cause less complications of nausea and vomiting after surgery. This study may help clarify if a pyloric drainage procedure is necessary in patients undergoing minimally invasive esophagectomy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02965976.
PRIMARY OBJECTIVE:
I. Determine if intra-pyloric botulinum toxin type A (botulinum toxin) injection (Botox) during a minimally invasive esophagectomy decreases postoperative occurrence of delayed gastric emptying.
SECONDARY OBJECTIVES:
I. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy reduces the number of repeat procedures for delayed gastric emptying within 90 days.
II. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy decreases time to oral intake meeting 100% of nutritional requirements.
III. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy reduces the incidence of pulmonary complications directly related to delayed gastric emptying.
IV. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy reduces hospital length of stay related to delayed gastric emptying.
V. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy increases patient quality of life.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive botulinum toxin type A injection intramuscularly (IM) while undergoing standard minimally invasive esophagectomy.
ARM II: Patients undergo standard minimally invasive esophagectomy.
After completion of study treatment, patients are followed up at 1-3 weeks, 6-8 weeks, and at 90 days.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorMoshim Kukar
