achalasie, dysfagie achalasia, dysphagia
Conditions
Interventions
All patients will receive balloon dilation treatment according to standard clinical practice using a 30 mm EsoFLIP balloon. Two days later, treatment will be repeated using the 30mm catheter.
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| -Safety. Safety will be assessed through documentation of Adverse Events and Serious Adverse Events. Serious adverse events are defined as major complications during the procedure or that are related to the dilation using the EsoFLIP catheter, during the procedure and afterwards during a follow up period of 3 months. The proportion of patients in the study not having a serious adverse event during or after the dilation procedure will be calculated. -Efficacy (clinical success), measured by the proportion of patients exhibiting symptomatic improvement. The achalasia-DSQoL questionnaire and Eckardt score shall be completed the day of the first dilation before the procedure, one week after the second dilation, one month after and three months after the second dilation. Should a third dilation be necessary, both the achalasia-DSQoL questionnaire and Eckardt score would be filled out prior to this procedure. Raw achalasia-DSQoL-questionnaire scores shall be converted to interval-level scores to produce a value between 0 and 100. A 10-point reduction in the interval level score shall be deemed an improvement for the purposes of calculating the secondary endpoint. (12,13) The number of patients having an Eckardt score >3 before the first dilation and three months after the final dilation will be recorded and the difference will be calculated. -The balloon pressure required to eliminate the waistline of balloon, which shall be measured in PSI. This number will be measured with a Dwyer Model 40-3 490-4 pressure monitor. Descriptive statistics shall be calculated for balloon pressure for the patient group. -The amount of radiation (in cGy•Cm2) used per patient during the procedure. This is measured by the standard institutional endoscopy device. -Treatment failure, defined as the number of patients requiring a third dilation because of persistent or recurrent symptoms. This would be done using a standard 35mm balloon. Patients will be followed up until three months after the | — |
Contacts
Public ContactW.F.W. Kappelle
P.O. box 85500 University Medical Center Utrecht Department of Gastroenterology & Hepatology Room F02.618
Outcome results
None listed