NCT02965976

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

Double-Arm, Randomized Study of Botulinum Toxin Injection as a Pyloric Drainage Procedure for Minimally Invasive Esophagectomy (Phase II)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Esophageal Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum Toxin Type A	Given IM
PROCEDURE	Esophagectomy	Undergo esophagectomy
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2016-12-30
• Primary completion: 2022-01-28
• Completion: 2022-04-28
• First posted: 2016-11-17
• Last updated: 2023-02-16
• Results posted: 2023-02-16

Locations

1 site across 1 country: United States