Efficacy & Safety of Submucosal Endoscopic Myotomy With Mucosal Flap (SEMF) in the Treatment of Patients With Achalasia
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.
|Achalasia Dysphagia||Procedure: Submucosal endoscopic myotomy with mucosal flap technique Procedure: Submucosal Endoscopic Mucosal Flap (SEMF) technique|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Prospective, Single Center, Proof of Concept Pilot Study of the Efficacy and Safety of Submucosal Endoscopic Myotomy With Mucosal Flap (SEMF) Technique in the Treatment of Patients With Achalasia|
- Change in Lower esophageal sphincter pressure (LES) [ Time Frame: at 3 months post endoscopic myotomy ]High Resolution Esophageal Manometry will be done at 3 months to measure LES and the result will be compared to baseline or pre-endoscopic myotomy LES pressure.
- Change in frequency of dysphagia [ Time Frame: 4 weeks post procedure ]Swallowing difficulty (dysphagia) will be assessed using the Modified Eckhardt Dysphagia Assessment Tool which includes asking the patient how often he/she experiences swallowing difficulty (0 = none, 1 = occasional, 2 = daily, and 3 = every meal. The score will be compared to pre-myotomy score.
- Change in frequency of Regurgitation [ Time Frame: 4 weeks post procedure ]Patient will be asked how often he/she brings up swallowed liquid/solid food or regurgitates (0 = none, 1 = occasional, 2 = daily, and 3 = every meal. The score will be compared to the score prior to the procedure.
- Change in frequency of chest pain [ Time Frame: 4 weeks post procedure ]The patient will be asked how often he/she experiences chest pain and the frequency (0 = none, 1 = occasional, 2 = daily, and 3 = every meal. The score will be compared to pre-myotomy score.
- Presence of perforation [ Time Frame: During endoscopic myotomy procedure ]Presence of perforation that is seen during the endoscopic procedure.
- Presence of bleeding [ Time Frame: During endoscopic myotomy procedure ]Occurence of bleeding during the procedure.
- Presence of mediastinal emphysema [ Time Frame: During endoscopic myotomy procedure ]Presence of mediastinal emphysema will be recorded.
- Presence of Infection [ Time Frame: 4 weeks post procedure ]Presence of infection within the first 4 weeks post myotomy will be recorded.
- Development of stricture at the myotomy site. [ Time Frame: 3 months post procedure ]Development of stricture will be assessed by performing an upper endoscopy for patients with change in their Modified Dysphagia Score.
- Presence and frequency of heartburn [ Time Frame: 4 weeks post procedure ]The patient will be asked for presence or absence of heartburn. If present, he/she will be asked for frequency (0 = none, 1 = occasional, 2 = daily, and 3 = every meal). The score will be compared to pre-myotomy score.
- Frequency of use of antacids (PPI, H-2 antagonists) [ Time Frame: 4 weeks post procedure ]The patient will be asked if he/she is using any type of antacid. If using antacid, he/she will be asked how often he/she is using it (0 = none, 1 = occasional, 2 = daily, and 3 = every meal). The score will be compared to pre-myotomy score.
- Change in patient's weight [ Time Frame: At 3, 6, 9, and 12 months post procedure. ]Post myotomy weight will be measured and recorded and compared to pre-myotomy weight.
|Actual Study Start Date:||April 8, 2011|
|Study Completion Date:||October 22, 2015|
|Primary Completion Date:||January 6, 2015 (Final data collection date for primary outcome measure)|
Submucosal Endoscopic Mucosal Flap Technique
Submucosal Endoscopic Mucosal Flap Technique
Procedure: Submucosal endoscopic myotomy with mucosal flap technique
Submucosal Endoscopy with Mucosal Flap (SEMF) technique involves the following: (1) injecting 0.9 % normal saline solution to create a submucosal cushion, (2) tiny cut is made into the cushion, (3) Balloon will be used to dilate the opening and allow passage of endoscope in the submucosal space, (4) Upon direct visualization of the muscle fibers, the doctor will cut the circular layers of the diseased muscles, and (5) Tiny clips will be used to close the tiny cut made earlier.
Other Names:Procedure: Submucosal Endoscopic Mucosal Flap (SEMF) technique
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438398
|United States, New York|
|Winthrop University Hospital|
|Mineola, New York, United States, 11501|
|Principal Investigator:||Stavros N Stavropoulos, MD||Winthrop University Hospital|