HYPerbaric OXygen therapy for benign anastomotIC esophageal strictures: a pilot study - HYPOXIC-study

niversity Medical Center Utrecht0 个研究点开始时间: 2013年3月12日最近更新: 2015年7月10日

试验速览

暂无简介。

•-Benign esophageal anastomotic stricture; defined as a stenosis at the esophagogastric anastomosis causing clinically significant dysphagia.
•-Clinically significant dysphagia; defined as grade 2 or worse on the Ogilvie scale
•-First presentation of dysphagia due to the stricture within 6 months after surgery
•-Recurrent or refractory stricture:
•> 5 previous dilation sessions for this indication
•-Last dilation < 1 week before the start of HBOT
•-Informed Consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Known or strongly suspected esophageal motility disorder
•-Known or strongly suspected malignant stricture
•-Non-anastomotic stricture
•-Contra indication for HBOT:
•oUntreated pneumothorax
•oRestrictive treated pneumothorax (without thoraxdrain)
•oSevere respiratory diseases (COPD or pulmonary emphysema)
•oActive infection of the upper airways
•oRecent surgery of the middle ear
•oRecent thoracic surgery
•oUncontrolled high fever
•oSevere epilepsy
•oTreatment with pulmonary toxic medication (bleomycine, doxorubicin, adriamycin, amiodaron, furadantine)
•oPrevious treatment with bleomycine with pulmonary toxic reaction
•oKnown pregnancy or premenopausal woman that are not surgically sterile or taking oral contraceptives

发起方