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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Winthrop University Hospital
Sponsor:
Information provided by (Responsible Party):
Dolorita de Jesus, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01438398
First received: March 28, 2011
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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 12 months from the time study participants undergo the endoscopic surgical procedure.


Condition Intervention
Achalasia
Dysphagia
Regurgitation
Procedure: Submucosal endoscopic myotomy with mucosal flap technique
Procedure: Submucosal Endoscopic Mucosal Flap (SEMF) technique

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • Change in Lower esophageal sphincter pressure (LES) [ Time Frame: at 3 months post endoscopic myotomy ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Presence of perforation that is seen during the endoscopic procedure.

  • Presence of bleeding [ Time Frame: During endoscopic myotomy procedure ] [ Designated as safety issue: Yes ]
    Occurence of bleeding during the procedure.

  • Presence of mediastinal emphysema [ Time Frame: During endoscopic myotomy procedure ] [ Designated as safety issue: Yes ]
    Presence of mediastinal emphysema will be recorded.

  • Presence of Infection [ Time Frame: 4 weeks post procedure ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Development of stricture will be assessed by performing an upper endoscopy for patients with change in their Modified Dysphagia Score.


Secondary Outcome Measures:
  • Presence and frequency of heartburn [ Time Frame: 4 weeks post procedure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Post myotomy weight will be measured and recorded and compared to pre-myotomy weight.


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Per Oral Endoscopic Myotomy (POEM)
  • Natural Orifice Transluminal Endoscopic Surgery (NOTES)
Procedure: Submucosal Endoscopic Mucosal Flap (SEMF) technique
Other Names:
  • Per Oral Endoscopic Myotomy
  • Natural Orifice Transluminal Endoscopic Surgery

Detailed Description:

The safety of the procedure and feasibility of the study will be measured by improvement in subjects' symptoms score, decrease in LES pressure, as well as the number and severity of complications or adverse events experienced by the subjects. A modified Eckhardt dysphagia assessment tool will be used in grading the dysphagia symptoms.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who are below 18 years of age
  2. Presence of coagulopathy
  3. Pregnancy
  4. 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
  5. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438398

Contacts
Contact: Dolorita P De Jesus, MS, ANP (516) 663-4620 ddejesus@winthrop.org

Locations
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Dolorita P De Jesus, MS, ANP    516-663-4620    ddejesus@winthrop.org   
Sub-Investigator: Collin EM Brathwaite, MD         
Sub-Investigator: Dolorita P De Jesus, MS, ANP         
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Stavros N Stavropoulos, MD Winthrop University Hospital
  More Information

No publications provided

Responsible Party: Dolorita de Jesus, Sub-Investigator, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01438398     History of Changes
Other Study ID Numbers: 10035
Study First Received: March 28, 2011
Last Updated: February 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
Submucosal endoscopic myotomy
Per Oral Endoscopic Myotomy
Natural Orifice Transluminal Endoscopic Surgery

Additional relevant MeSH terms:
Esophageal Achalasia
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 24, 2014