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Technical feasibility of the EsoFLIP Achalasia Dilation Balloon


- candidate number16146
- NTR NumberNTR4371
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-okt-2013
- Secondary IDs13/050 Ethical committee Utrecht
- Public TitleTechnical feasibility of the EsoFLIP Achalasia Dilation Balloon
- Scientific TitleTechnical feasibility of the EsoFLIP Achalasia Dilation Balloon
- ACRONYMEsoFLIP-study
- hypothesisThe objective of this study is to assess the technical feasibility of the EsoFLIP dilation balloon in the treatment of achalasia.
- Healt Condition(s) or Problem(s) studiedDysphagia, Achalasia
- Inclusion criteriaPatients 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 criteriaPatients 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 23-jul-2013
- planned closingdate23-jul-2014
- Target number of participants10
- InterventionsAll 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.
- Primary outcomeThe 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-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 second dilation in which the EsoFLIP catheter was used.
- Timepointsbaseline: 1. Patient characteristics 2. Eckardt score 3. Achalasia DSQoL 4. Conventional manometry 5. Upper endoscopy One week after the second dilation: 1. Eckardt score 2. Achalasia DSQoL 3. (S)AE's One month after the second dilation: 1. Eckardt score 2. Achalasia DSQoL 3. (S)AE's Three months after the second dilation: 1. Eckardt score 2. Achalasia DSQoL 3. (S)AE's
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD W.F.W. Kappelle
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P.D. Siersema
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Crospon Ltd.
- PublicationsO¡¯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.
- Brief summaryAchalasia is a rare disease characterized by a disorder of esophageal motility and a failure of the lower esofageal sphincter (LES) to relax. Clinically, it is characterized by dysphagia, retrosternal pain and the regurgitation of undigested food. There is no curative treatment available for achalasia. For this reason, treatment is focused on facilitating the emptying of the esophageal contents by decreasing the LES pressure. Achalasia is treated with medication, injection of botulism toxin, surgically by Heller myotomy or endoscopically by either ¡°per-oral endoscopic myotomy¡± (POEM) or pneumatic balloon dilation. In the latter case, a balloon is inserted into the esophagus and dilated to a pressure of approximately 1.5 atm. Therapeutic success is approximately 90% for standard balloon dilation. Most balloons are calibrated to achieve a target diameter for a given balloon pressure in free air. It is however not necessarily the case that in-vivo the target diameter is achieved due to resistance/recoil from the esophagus. Fluoroscopy is often used to assess the lumen diameter post-dilation. This exposes the patient to radiation and does not give an actual lumen measurement (unless a prior calibration procedure is performed). With a new dilation catheter, the EsoFLIP, it is possible to measure the balloon diameter electronically during dilation. The EsoFLIP uses a commercially available impedance measurement technique with a series of measuring electrodes located within the dilation balloon. The balloon itself is a standard dilation balloon. With this technique, a digital image can be shown on a computer monitor, which accurately shows the shape of the balloon at that time. This obviates the need for radiation exposure.
- Main changes (audit trail)24-3-2014: wijziging aantal deelnemers: was 20
- RECORD22-jan-2014 - 24-mrt-2014


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