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

niversitair Medisch Centrum Utrecht0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月29日

适应症

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

•- Known or strongly suspected esophageal motility disorder
•- Known or strongly suspected malignant stricture
•- Non-anastomotic esophageal stricture
•- Contra indication for HBOT:
•- Untreated pneumothorax
•- Restrictive treated pneumothorax (without thoraxdrain)
•- Severe respiratory diseases (COPD or pulmonary emphysema)
•- Active infection of the upper airways
•- Recent surgery of the middle ear
•- Recent thoracic surgery
•- Uncontrolled high fever
•- Epilepsy
•- Treatment with pulmonary toxic medication (bleomycine, doxorubicin, adriamycin, amiodaron,
•furadantine)
•- Previous treatment with bleomycine with pulmonary toxic reaction
•- Known pregnancy or premenopausal woman that are not surgically sterile or taking oral
•contraceptives

发起方

niversitair Medisch Centrum Utrecht