A Phase III Randomized Trial of Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 143
- 试验地点
- 4
- 主要终点
- esophageal anastomosis leak requiring surgery
研究概览
简要总结
This research study is a phase III randomized trial to study the value of the addition of a pyloroplasty procedure versus no pyloroplasty procedure during the performance of esophagectomy. Pyloroplasty is a type of pyloric drainage procedure.
详细描述
Patients selected for enrollment in this study will be adults (18-85 years of age) that have been scheduled for exploration, and possible esophagectomy. Prior to surgery, patients will be randomized to one of two groups. Group A will have a pyloroplasty performed as part of the esophagectomy procedure. Group B will not have a pyloroplasty performed. Postoperative patient outcomes will be assessed for 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be willing to undergo esophagectomy for benign or malignant condition
- •Women and men 18-85 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Stomach is used as conduit
排除标准
- •Previous operations of the pylorus
- •Previous gastric resection
- •Previous gastric bypass
- •Patients who are unable to tolerate surgery
- •Participants may be enrolled and randomized on the study but may be excluded at the time of the surgery because of findings by the surgeon that preclude performing esophagectomy, or using stomach as a conduit or findings which preclude following the randomized arm.
- •Age <18 years of age or > 85 years of age
- •BMI > 50
- •Liver cirrhosis or liver failure at physician's discretion
研究组 & 干预措施
Esophagectomy with Pyloroplasty
Esophagectomy with Pyloroplasty
干预措施: Esophagectomy (Procedure)
Esophagectomy with Pyloroplasty
Esophagectomy with Pyloroplasty
干预措施: Pyloroplasty (Procedure)
Esophagectomy without Pyloroplasty
Esophagectomy without Pyloroplasty
干预措施: Esophagectomy (Procedure)
结局指标
主要结局
esophageal anastomosis leak requiring surgery
时间窗: 30 days postoperatively
Defined as a leak at the esophageal anastomosis site as evidenced by Barium Swallow Study.
pneumonia
时间窗: 30 days postoperatively
Defined as meeting 3 of 5 characteristics: fever, leukocytosis, chest x-ray (CXR) with infiltrate, positive culture from sputum, or treatment with antibiotics
次要结局
- Mortality(30 days)
- Quality of life assessment by completion of SF36 Quality of Life questionnaire(Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery)
- Aspiration as reported on radiographic imaging(Performed when clinically indicated up to 24 months postoperatively)
- Esophageal anastomotic leak not requiring surgery(Performed when clinically indicated up to 24 months postoperatively)
- Dysphagia as reported by patient using the Dysphagia scale(Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery.)
- Time to start oral diet(Up to 24 months)
- Nasogastric tube drainage measured in milliliters(From date of surgery until date nasogastric tube is removed or date of discharge from hospital, whichever came first, assessed up to 24 months.)
- Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life (HRQL) measured by completion of GERD HRQL questionnaire(Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery.)
- Replacement of nasogastric tube reported as number of days from tube removal to reinsertion(Up to 24 months)
- Unexpected return to the Operating Room(Up to 24 months postoperatively)
- Respiratory complications other than pneumonia(Performed when clinically indicated up to 24 months postoperatively)
- Length of hospital stay(From date of surgery until the date of discharge from hospital, assessed up to 24 months.)
- Esophageal dilations reported as the number of esophageal dilations performed(Up to 24 months)
- Gastric outlet obstruction as reported on barium swallow reports(Performed when clinically indicated up to 24 months postoperatively)
- Re-admission to hospital(Up to 24 months postoperatively)
研究者
James Luketich
Principal Investigator
University of Pittsburgh