Pylorus Dysfunction After Esophagectomy. Effect of Pneumatic Dilatation.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Symptoms suggestive of delayed gastric emptying
研究概览
简要总结
Delayed emptying of the gastric tube after esophagectomy is a frequent and durable problem. No treatment is currently available. It can be hypothesized that incomplete relaxation of the pyloric sphincter may be a significant contributing factor. Pneumatic dilatation may therefore be a potentially effective treatment.
详细描述
Patients surviving one year after esophagectomy are sent questionnaires to pick up symptoms suggestive of delayed gastric emptying.Those fulfilling predefined criteria for delayed gastric emptying will be invited to the study. The study design is sham controlled single blind with a follow up extending to twelve months post treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous esophagectomy and gastric tube reconstruction.
- •Symptoms suggestive of delayed gastric emptying.
- •signed informed consent
排除标准
- •Signs of recurrent cancer disease
- •no symptoms suggestive of delayed gastric emptying.
- •unwillingness to participate
研究组 & 干预措施
15 mm Pyloric balloon dilatation.
During fluoroscopic control the pneumatic balloon is positioned of the pyloric sphincter and maintained there during the entire dilatation.
干预措施: 15 mm pyloric balloon dilatation (Other)
Pneumatic pyloric dilatation.
Endoscopy and 15 mm balloon dilatation is completed according to the same principle as active comparator arm.
干预措施: Pneumatic pyloric dilatation (Device)
结局指标
主要结局
Symptoms suggestive of delayed gastric emptying
时间窗: 3-12 months after treatment
Symptoms will be assessed at 3, 6 and 12 months after therapy. In case of failure the code will be broken and if sham procedure has been done the patient will be offered pneumatic dilatation.
次要结局
- Quality of Life(3-12 months after treatment.)
- Delayed gastric emptying(3, 6 and 12 months after treatment.)
研究者
Lars Lundell
Professor
Karolinska University Hospital