Technical feasibility of the EsoFLIP Achalasia Dilation Balloon

Achalasia 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.

The objective of this study is to assess the technical feasibility of the EsoFLIP dilation balloon in the treatment of achalasia.

baseline:
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

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.