跳至主要内容
临床试验/NCT02166957
NCT02166957已完成不适用

Evaluation of the Effectiveness of Endoscopic "Rendez-vous" Technique for Esophageal Reconstructions for the Treatment of a Total and Extensive Disruption of the Esophagus

Société Française d'Endoscopie Digestive1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Effectiveness of the rendez vous approach for treating esophageal disruption

研究概览

简要总结

Complete esophageal obstructions leads to definitive fasting. The rendez-vous endoscopic approach had already been described for complex stenoses but never for disruption with loss of tissue and SES. Patients and methods: This is a retrospective observationnal study about patients referred for complete esophageal disruption and classified in two groups: 1/ Long disruption (> 5cm), after caustic ingestion or due to an esophageal stripping during SEMS removal; 2/ Short disruption (< 5cm), consecutive to radiation therapy. All the procedures are performed according the anterograde retrograde approach, using CO2 and under X-rays guidance. We report the characteristeristics of the procedures, the efficacy, the time before discharge and refeeding, the complications, and the follow-up, especially the number of dilatation sessions for each group. The hypothesis is that anterograde retrograde endoscopic technique is safe and effective for the management of esophageal disruptions in patients for which the surgical treatment confers a high risk of morbidity and mortality.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Esophageal disruption with or without loss of SES

排除标准

  • Esophageal Complex stenosis
  • Mediastinitis
  • Severe sepsis
  • Coagulation abnormalities
  • Contra-indications to general anesthesia

结局指标

主要结局

Effectiveness of the rendez vous approach for treating esophageal disruption

时间窗: 2 days

We evaluate the technical and the clinical success. The technical success is the ability to recanalize the esophagus endoscopically. The clnical success is the possibility to feed patients.

次要结局

  • Complications(7 days)
  • Number of endoscopic dilation sessions after recanalization(Up to 2 years)
  • Number of endoscopic sessions(Up to 2 years)
  • Time before refeeding(15 days)

研究者

发起方
Société Française d'Endoscopie Digestive
申办方类型
Other
责任方
Principal Investigator
主要研究者

VANBIERVLIET

MD

Société Française d'Endoscopie Digestive

研究点 (1)

Loading locations...

相似试验