Double-Arm, Randomized Study of Botulinum Toxin Injection as a Pyloric Drainage Procedure for Minimally Invasive Esophagectomy (Phase II)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Delayed Gastric Emptying Assessed Radiographically by Nuclear Medicine Emptying Study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Esophageal carcinoma, undergoing minimally invasive esophagectomy with intrathoracic anastomosis
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- •Participant 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
排除标准
- •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 chronic narcotic use over 2 years due to non-cancer causes
- •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
研究组 & 干预措施
Arm I (botulinum toxin type A, esophagectomy)
Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy.
干预措施: Esophagectomy (Procedure)
Arm I (botulinum toxin type A, esophagectomy)
Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy.
干预措施: Quality-of-Life Assessment (Other)
Arm II (esophagectomy)
Patients undergo standard minimally invasive esophagectomy.
干预措施: Esophagectomy (Procedure)
Arm II (esophagectomy)
Patients undergo standard minimally invasive esophagectomy.
干预措施: Quality-of-Life Assessment (Other)
Arm I (botulinum toxin type A, esophagectomy)
Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy.
干预措施: Botulinum Toxin Type A (Biological)
结局指标
主要结局
Delayed Gastric Emptying Assessed Radiographically by Nuclear Medicine Emptying Study
时间窗: Up to day 21
Will be assessed using the intent-to-treat principle and a one-sided Cochran-Mantel-Haenszel (CMH) test.
次要结局
- Delayed Gastric Emptying Assessed Radiographically by Gastrografin Swallow OR CT Esophagram(At day 7)
- Hospital Length of Stay Attributed to Delayed Gastric Emptying(Up to 90 days)
- Pulmonary Events Directly Related to Delayed Gastric Emptying as Assessed by Operating Surgeon(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(Up to day 90)
- Gastrointestinal and Nutritional Status Including Days to Resumption of Oral Feeding as Assessed by Dietician(Up to day 35)
- Secondary Procedure Due to Delayed Gastric Emptying(Up to 90 days)