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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
33
Given IM
Undergo esophagectomy
Ancillary studies
Roswell Park Cancer Institute
Buffalo, New York, United States
Delayed Gastric Emptying Assessed Radiographically by Nuclear Medicine Emptying Study
Will be assessed using the intent-to-treat principle and a one-sided Cochran-Mantel-Haenszel (CMH) test.
Time frame: Up to day 21
Delayed Gastric Emptying Assessed Radiographically by Gastrografin Swallow OR CT Esophagram
Delayed gastric emptying assessed Radiographically by Gastrografin Swallow OR CT Esophagram at day 7. Will be compared between treatment arms using the two-sided CMH exact test.
Time frame: At day 7
Gastrointestinal and Nutritional Status Including Days to Resumption of Oral Feeding as Assessed by Dietician
The days to resumption of oral feeding are calculated based on return to a solid diet. Will be compared between treatment arms using the two sided independent-sample, stratified T-test.
Time frame: Up to day 35
Hospital Length of Stay Attributed to Delayed Gastric Emptying
The total length of stay is calculated as the difference between the date of procedure and date of discharge. Will be compared between treatment arms using the two sided independent-sample, stratified T-test.
Time frame: Up to 90 days
Secondary Procedure Due to Delayed Gastric Emptying
The rate of secondary procedures (within 90 days) will be compared between treatment arms using a one-sided CMH exact test.
Time frame: Up to 90 days
Pulmonary Events Directly Related to Delayed Gastric Emptying as Assessed by Operating Surgeon
The rate of post-operative pulmonary events will be compared between treatment arms using the two-sided CMH exact test.
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Time frame: Up to day 90
Quality of Life Score as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 OES18
Will be compared between treatment arms using the two sided independent-sample, stratified T-test.
Time frame: Up to day 90