PROGRESSIVE ESOPHAGEAL DILATION FOR BENIGN STRICTURES: A RANDOMIZED CONTROLLED TRIAL - PROGRESSIVE ESOPHAGEAL DILATION FOR BENIGN STRICTURES

Radboud Universitair Medisch Centrum0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•- Dysphagia due benign esophageal stricture requiring esophageal dilation (e.g. surgery, radiation therapy, caustic ingestion, peptic injury, photodynamic therapy)
•- Requiring first esophageal dilation for dysphagia due to a severe benign esophageal stricture with no patency for standard upper endoscope (9-10mm diameter)
•- No history of esophageal endoscopic dilations for benign strictures the past 6 months
•- Dysphagia for solid, semisolid or liquid food (dysphagia score <= 2 [Ogilvie]16, and dysphagia score <= 21 [Dakkak and Bennett]19, see appendix)
•- Written informed consent

•- Patient < 18 years old
•- Patient is unwilling or unable to sign and date the informed consent
•- Patient is unwilling or unable to comply with the follow-up schedule
•- Patient is unable to understand informed consent and fill in the questionnaires due to a language barrier
•- Patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 month
•- Patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study
•- Previous esophageal dilation for benign stricture within the past 6 months
•- Patient with a life expectancy < 12 months
•- Patient with a known eosinophilic esophagitis or motility disorder (such as achalasia)
•- Patients with a known malignant esophageal stricture
•- Patients with coagulopathy
•- Patients with a benign stricture due to a previous performed laryngectomy

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