NCT02017366撤回不适用
Design of the EFECTS Trial, Investigating the Influence of Postoperative Enteral Feeding in Esophageal Cancer paTients on Survival
University Hospital, Gasthuisberg2 个研究点 分布在 1 个国家开始时间: 2018年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- overall survival from day of surgery
研究概览
简要总结
It is well known that there is a considerable postoperative weight loss in patients undergoing esophageal resection for cancer.
We believe that this weigh loss can be limited by administering postoperative enteral feeding (target: 1000 kCal/ day) via feeding jejunostomy for at least 6 weeks postoperatively.
We hypothesize that patients undergoing esophageal resection for cancer will have a better overall survival with postoperative additional enteral feeding than when on regular oral diet alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
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
- •advanced cT2 N+ or cT3 Nx
- •all histology
- •GEJ or distal esophageal ACC
- •proximal or mid SCC
- •curative intent with intention to treat
- •at least two-field lymphadenectomy
- •all access: MIE, left thoraco freno or R thoraco + laparotomy with intrathoracic or cervical anastomosis
- •all anastomosis (intrathoracic, cervical)
排除标准
- •transhiatal
- •pt in definitive CRT or rescue resection following definitive CRT
- •palliative treatment
- •tumours in cervical esophagus
- •pharyngeal cancer with gastric pull-up
结局指标
主要结局
overall survival from day of surgery
时间窗: 5 years postoperative
overall survival at 5 years after esophagectomy
次要结局
- postoperative weight loss(1 year after surgery)
研究者
Hans Van Veer, MD
MD
University Hospital, Gasthuisberg
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Study of Surgically-Induced Weight Loss on Pelvic Floor DisordersPelvic Floor DisordersNCT00884871University of California, San Diego100
招募中
不适用
Outcomes After Weight Loss Surgery in Low-Risk PatientsWeight LossBariatric SurgeryNCT05699083Dr. Feiz & Associates20
招募中
不适用
Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine.Low Back Pain in Obese Patients After Important Weight LossNCT04893954Assistance Publique - Hôpitaux de Paris80
终止
2 期
The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body CompositionBariatric SurgeryNCT00686972Johns Hopkins University51
Unknown
不适用
Effect of BAriatric Surgery Versus Optimal Medical Therapy on Cardiovascular Health and Atherosclerosis in Obese, Type II Diabetic PatientsObesityAtherosclerosisDiabetes Mellitus, Type 2NCT02331420Catholic University of the Sacred Heart58