Efficacy & Safety of Submucosal Endoscopic Myotomy With Mucosal Flap (SEMF) in the Treatment of Patients With Achalasia

NCT01438398 | Completed DMC

• 1 other identifier: 10035
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Achalasia; Dysphagia

Keywords

Submucosal endoscopic myotomy; Per Oral Endoscopic Myotomy; Natural Orifice Transluminal Endoscopic Surgery

Outcome Measures

Primary Outcomes (9)

• Change in Lower esophageal sphincter pressure (LES)

  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.

  at 3 months post endoscopic myotomy

• Change in frequency of dysphagia

  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.

  4 weeks post procedure

• Change in frequency of Regurgitation

  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.

  4 weeks post procedure

• Change in frequency of chest pain

  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.

  4 weeks post procedure

• Presence of perforation

  Presence of perforation that is seen during the endoscopic procedure.

  During endoscopic myotomy procedure

• Presence of bleeding

  Occurence of bleeding during the procedure.

  During endoscopic myotomy procedure

• Presence of mediastinal emphysema

  Presence of mediastinal emphysema will be recorded.

  During endoscopic myotomy procedure

• Presence of Infection

  Presence of infection within the first 4 weeks post myotomy will be recorded.

  4 weeks post procedure

• Development of stricture at the myotomy site.

  Development of stricture will be assessed by performing an upper endoscopy for patients with change in their Modified Dysphagia Score.

  3 months post procedure

Secondary Outcomes (3)

• Presence and frequency of heartburn

  4 weeks post procedure

• Frequency of use of antacids (PPI, H-2 antagonists)

  4 weeks post procedure

• Change in patient's weight

  At 3, 6, 9, and 12 months post procedure.

Study Arms (1)

Submucosal Endoscopic Mucosal Flap Technique

OTHER

Submucosal Endoscopic Mucosal Flap Technique

Procedure: Submucosal endoscopic myotomy with mucosal flap technique; Procedure: Submucosal Endoscopic Mucosal Flap (SEMF) technique

Interventions

Submucosal endoscopic myotomy with mucosal flap technique PROCEDURE

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.

Also known as: Per Oral Endoscopic Myotomy (POEM), Natural Orifice Transluminal Endoscopic Surgery (NOTES)

Submucosal Endoscopic Mucosal Flap Technique

Submucosal Endoscopic Mucosal Flap (SEMF) technique PROCEDURE

Also known as: Per Oral Endoscopic Myotomy, Natural Orifice Transluminal Endoscopic Surgery

Submucosal Endoscopic Mucosal Flap Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years or older, male or female, belonging to any race or ethnic origin
• Patients with manometric positive diagnosis of achalasia, with corresponding symptoms of dysphagia, regurgitation of food or chest pain
• Patients who are willing and competent to sign Informed Consent and to comply with study related visits and procedures

You may not qualify if:

• Patients who are below 18 years of age
• Presence of coagulopathy
• Pregnancy
• Patients who, in the investigator's opinion, are medically unstable, are unable to give informed consent, or whose risks outweigh the benefits of participating in the study
• Vulnerable subjects: Prisoners, persons with decisional incapacity, and any person who are directly involved in the study, including their immediate family members, and anybody who may have any conflict of interest such as employees of ERBE, USA.

Sponsors & Collaborators

• Winthrop University Hospital: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Esophageal Achalasia; Deglutition Disorders

Interventions

Natural Orifice Endoscopic Surgery; Methods

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Stavros N Stavropoulos, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Advanced Endoscopist

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: September 22, 2011
• Study Start: April 8, 2011
• Primary Completion: January 6, 2015
• Study Completion: October 22, 2015
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

US (1)