Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer

PRIMARY OBJECTIVES:

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 2, 3-4, and 6-8 weeks, and
at 90 days.

Inclusion Criteria:

- Esophageal carcinoma, undergoing minimally invasive esophagectomy with intrathoracic
anastomosis

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

- Participant or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

- Patients who have a history of gastrointestinal dysmotility or functional
gastroparesis, including diabetic gastroparesis, central and peripheral nervous system
disorders, renal failure, medication side effects, including chronic dependence of
promotility agents, anticholinergic antispasmodic agents, or daily narcotic use

- Patients who have a history of previous gastric or duodenal surgery

- Patients who have a history of duodenal ulcer or duodenal fibrosis

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Allergy to botulinum toxin and/or egg

- Pregnant or nursing female participants

- Unwilling or unable to follow protocol requirements

- Any condition which in the investigator's opinion deems the participant an unsuitable
candidate for study participation