Active clinical trials for "Esophageal Achalasia"

Spastic esophageal motility disorders induced significant symptoms including dysphagia, retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel approach to perform myotomy through the esophagus with long submucosal tunnel. This study aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from animal study to clinical practice in human.

Treatment options for achalasia include endoscopic dilations and surgical myotomy. Recently the POEM (Per oral endoscopic myotoymy) technique has been described. Patients undergo myotomy under endoscopic control. It has advantage over endoscopic dilation since myotomy is performed, and has advantage over surgery because it is performed endoscopically, thus is less invasive. One potential disadvantage in respect to surgery may be that it may determine higher rates of post-operative reflux. The purpose of this study is to prospectively assess the feasibility of PEOM in our Center with the new hybrid knife, and clinical results at 1, 3 and 12 months. This is a prospective, phase II study. Ten patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will be included for the POEM procedure. This study will last about 2 years. The aim is the feasibility, security and success rate of POEM for achalasia. Patients will be followed for at least one year.

Achalasia is an esophageal motility disease that usually requires surgical intervention (esophagomyotomy). Laparoscopic techniques have reduced the morbidity associated with myotomy, but post-op GERD, wound infection, hernia and incisional pain are common. A new NOTES based procedure, per-oral endoscopic esophagomyotomy (POEM), has been developed that eliminates the need for skin incisions. All patients enrolled in this study, will have a thorough pre-op workup (including upper endoscopy, upper GI radiographs, high resolution esophageal manometry) confirming the diagnosis of achalasis at the Northwestern Esophageal Center. In this procedure, performed in the operating room under general anesthesia, a flexible endoscope is passed into the esophagus, a mucosal flap and a submucosal tunnel is created. This tunnel extends onto the stomach. The inner circular muscle layer of the lower esophagus and sphincter (LES) is identified and a myotomy is started 3-4cm distal to the mucosal flap and carried all the way onto the stomach. The mucosal opening is then closed with standard endoscopic clips. Patients will be admitted to the hospital and a gastrograffin esophagram will be performed on post-op day 1 to rule out esophageal leak. All patient will have a 2-3 week post-op appointment Patients with a confirmed diagnosis of achalasia may be offered POEM. The investigators hypothesize that POEM is feasible and safe and can effectively reduce residual LES pressure (as determined by manometry) and improve patients symptoms and quality of life.

Achalasia is an esophagus motor disability characterized by a lack of relaxation of the lower esophageal sphincter (LES) to deglutition. Myotomy is the gold standard surgical technique allowing to cure this pathology. In this study, investigators are using a new endoluminal technique of myotomy, innovative and less invasive, called POEM (PerOral Endoscopic Myotomy). This technique does not require any cutaneous incision. Mini-invasive surgery is more and more associated to endoscopy. The practice was initiated by the accession of natural orifice transluminal endoscopic surgery (NOTES). In this context, the introduction of the POEM technique seems to be an original approach and a natural evolution to a new generation of surgical endoscopy.

This is a study of the safety and efficacy of a new surgical procedure using endoscopic instruments and a tunneling technique to reach the LES for dissection. We hypothesize that this technique provides an incisionless, less invasive option with similar functional outcome compared to standard Heller myotomy.

Recent work at St. Thomas' has validated an innovative new design of a multichannel intraluminal impedance (MII) catheter that is sensitive to variation in oesophageal volume in healthy volunteers and patients. This project will establish the clinical value of volume sensitive MII (vMII) compared to conventional MII acquired simultaneously by the same catheter (ROC analysis). Studies will assess: The accuracy of volume measurements and correlation between symptoms and the volume of bolus retention in patients with dysphagia. The accuracy of volume measurements and correlation between symptoms and reflux volume in patients with reflux disease. Follow up studies after appropriate treatment will assess whether symptomatic improvement is associated with a reduction in oesophageal volume retention/reflux. The vMII technique will be applied with high resolution manometry (HRM). These investigations are complementary in that vMII assesses the success or failure of bolus transport (or occurrence of reflux) and HRM can assess: the oesophageal dysfunction that results in bolus escape the abnormal events at the gastro-oesophageal junction (reflux barrier) that allow reflux to occur. with a reduction in oesophageal volume retention / reflux.

The investigators wish to monitor the adoption of a new, incisionless approach to performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic Myotomy (POEM), will provide less-invasive treatment for esophageal achalasia, ideally providing similar if not better outcomes (safety and efficacy) as the Heller myotomy. The investigators hope to enroll 10 patients with a clinical diagnosis of achalasia who meet inclusion criteria. The POEM procedure has been done in many hospitals without any research associated with it. Dr. Ginsberg, Dr. Chandrasekhara and Dr. Kochman will perform the procedures after being trained. Dr. Ginsberg has personally witnessed the performance of 10 POEM procedures and has performed in a swine model. The PI is credentialed to initiate POEM at HUP with the first case to be proctored by an experienced operator. The PI will then proctor the other adopters. The investigators would like to evaluate the safety of it and the effectiveness of it. The investigators will use their symptom scores and radiology tests pre- and post-POEM to evaluate effectiveness.

This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.

POEM is a new intervention for the treatment of achalasia and has been reported to relieve the dysphagia symptom effectively. Although the cost of POEM method is less than the method of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the patients with achalasia. In this trial, investigators plan to use snare to assist POEM procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared with other knifes-assisted procedure.

The purpose of this study is to learn about the safety and usefulness of a procedure called endoscopic submucosal myotomy, which is a new technique in the treatment of achalasia. Achalasia is a disorder involving the lack of smooth muscle relaxation and sustained high pressure in the sphincter (muscle) of the lower esophagus. This may result in symptoms such as difficulty in swallowing, chest pain, regurgitation of food and eventually, weight loss. For more than a decade, a laparoscopic surgical procedure known as Heller myotomy has been the primary treatment for achalasia in patients with low surgical risk. In Heller myotomy, the surgeon makes three to four small abdominal incisions, inserts tube-like instruments through them, and once inside, the junction between the esophagus and stomach is found, a lengthwise incision is made on the muscular ring surrounding the lower esophageal sphincter which weakens the muscle and the lower esophageal sphincter or muscle (LES) is then able to open more easily. However, there is an emerging field known as natural orifice (opening) transluminal (through the lumen) endoscopic surgery (NOTES). This approach involves passing an endoscope - a thin tube with a built-in camera, light and minuscule tools through the natural opening in the body, like the mouth in order to perform less invasive surgery without any external wounds or scars. The procedure is done using the Submucosal Endoscopy with Mucosal Flap (SEMF) technique which involves passing an endoscope through the mouth into the esophagus, where a small incision is made on the lining of the esophagus, known as the mucosa. A balloon is then inserted and dilated in the submucosa - the layer between the inner lining of the esophagus and the outer wall consisting of the muscle of the esophagus. Dilation of the balloon in the submucosa creates a tunnel that allows insertion of the endoscope and access to the muscle of the lower esophageal sphincter (LES). A long incision is then carefully made on the posterior portion of the muscular ring that forms the LES. The incision divides the muscle fibers of the LES, which weakens the muscle, allowing for the easier passage of food while preserving some valve function to prevent reflux of acid from the stomach into the esophagus. The expected duration of participation is up to 10 years from the time study participants undergo the endoscopic surgical procedure.