Technical feasibility of the EsoFLIP Achalasia Dilation Balloo

Recruiting

Conditions: achalasie, dysfagieachalasia, dysphagia

Registration Number: NL-OMON22452

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: O¡¯Dea, John, and Peter D. Siersema. "Esophageal dilation with integrated balloon imaging: initial evaluation in a porcine model." Therapeutic advances in gastroenterology 6.2 (2013): 109-114.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Patients have to meet the following criteria:
-Between 18 and 70 years of age
-Diagnosed with achalasia by absence of peristalsis and impaired relaxation of the LES (during swallow-induced relaxation a residual pressure of ¡Ý10mmHg) on standard manometry
-Eckardt symptom score >3 at baseline (5) (Appendix I)
-Eligible for standard pneumatic balloon dilation therapy
-Patients have signed the informed consent form
-Patients are willing and able to fill out the questionnaires

Exclusion Criteria

Patients will be excluded in case of:
-Previous invasive treatment for achalasia
-Pseudoachalasia
-Megaesophagus (diameter of ¡Ý7 cm)
-Altered anatomy of the esophagus due to surgery
-Barrett¡¯s epithelium (>M2; >C1) or any grade of dysplasia, seen during endoscopy or in a biopsy in the past six months
-A history of either suspected or confirmed esophageal cancer
-Confirmed eosinophilic esophagitis
-Liver cirrhosis, portal hypertension and/or esophageal varices
-Coagulopathy (INR>1.5, platelets<50.000/mm3) which has not been corrected prior to the procedure
-Any condition that, at the discretion of the principal investigator, would preclude participation in the trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study is technical feasibility of the EsoFLIP dilation balloon in the treatment of achalasia. Technical success is defined as a successful dilation of the EsoFLIP balloon after capturing two digital EndoFLIP system images of the gastroesophageal junction (GEJ). The first image is captured prior to dilation, the last image post-dilation. The last image will show the image of the balloon at the point where, in the opinion of the Principal Investigator, the waistline of the balloon is adequately eliminated. Since the EsoFLIP is also capable of measuring the minimum diameter of the LES, this will be recorded before and after dilation.

Secondary Outcome Measures