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Anterior Orientation vs Posterior Orientation in Per Oral Endoscopic Myotomy POEM for the Treatment of Achalasia

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ClinicalTrials.gov Identifier: NCT03228758
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Stavros Stavropoulos, MD, Winthrop University Hospital

Brief Summary:

The purpose of this study is to compare the safety and efficacy of the anterior versus posterior myotomy technique in Per Oral Endoscopic Myotomy (POEM) for the treatment of Achalasia. The primary efficacy outcome is periprocedural pain requiring the use of narcotics. The secondary outcomes focus on safety which includes technical procedure duration time; tunneling time, myotomy time, and closure time; incidence of mucosotomy (transmural and non-transmural injury), capnoperitoneum, and the postoperative sequelae of gastrointestinal reflux disease (GERD). Periprocedural pain data collection will include post POEM procedure pain scores, administrations of analgesia until discharge.

The final analysis will focus on determining whether there is a statistically significant difference in the amount and severity of pain in the Anterior versus Posterior myotomy subject populations. Additional analysis will be the collection of analgesic type (narcotic versus non-narcotic), dosage, frequency, and duration of treatment from post POEM procedure in the endoscopy recovery suite until the subjects are discharged.


Condition or disease Intervention/treatment Phase
Achalasia Procedure: Per Oral Endoscopic Myotomy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to either the anterior or posterior orientation approach to the endoscopic myotomy.
Masking: Single (Participant)
Masking Description: Subjects will not be made aware of the orientation approach to the endoscopic myotomy.
Primary Purpose: Treatment
Official Title: Efficacy of Anterior Versus Posterior Myotomy Approach in Per Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia - A Single Operator Analysis
Actual Study Start Date : July 24, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: Anterior Orientation

The anterior endoscopic myotomy of the lower esophageal sphincter will be performed between the 11 o'clock to 3 o'clock position in the esophagus determined by the usual endoscopic convention of 12 o'clock representing the most anterior aspect of the esophagus on endoluminal view.

Intervention is the endoscopic myotomy of the lower esophageal sphincter.

Procedure: Per Oral Endoscopic Myotomy
The Per Oral Endoscopic Myotomy procedure is the cutting of the lower esophageal sphincter. This procedure is a natural orifice transluminal endoscopic surgery (NOTES)

Active Comparator: Posterior Orientation

The posterior endoscopic myotomy of the lower esophageal sphincter will be performed between the 5 o'clock to 6 o'clock position in the esophagus determined by the usual endoscopic convention of 12 o'clock representing the most anterior aspect of the esophagus on endoluminal view.

Intervention is the endoscopic myotomy of the lower esophageal sphincter.

Procedure: Per Oral Endoscopic Myotomy
The Per Oral Endoscopic Myotomy procedure is the cutting of the lower esophageal sphincter. This procedure is a natural orifice transluminal endoscopic surgery (NOTES)




Primary Outcome Measures :
  1. Periprocedural pain requiring the use of narcotics. [ Time Frame: Within the first 48 hours after the procedure. ]
    Pain related to the endoscopic myotomy requiring the use of narcotic pain medication.


Secondary Outcome Measures :
  1. Incidence of Gastrointestinal Reflux Disease (GERD) [ Time Frame: Within 3 months after the procedure. ]
    Gastrointestinal Reflux Disease measured by BRAVO pH study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who have been diagnosed with Achalasia Type I, II, or III by positive manometric findings and supporting findings by timed barium esophagram and endoscopy.
  2. Subjects who are willing and competent to sign Informed Consent and to comply with study related visits and procedures.

Exclusion Criteria:

  1. Subjects who are under 18 years of age
  2. Subjects with Achalasia Type I, II, or III who have had a prior failed open or laparoscopic Heller myotomy; or have an esophageal diverticula, or anatomical variant dictating the approach of the myotomy
  3. Subjects diagnosed with other motility disorders such as distal esophageal spasm (DES), hypertensive peristalsis (Nutcracker), or hypercontractile esophagus (Jackhammer)
  4. Subjects with coagulopathy
  5. Pregnant females
  6. Subjects who in the investigators' opinion, are medically unstable , are unable to give informed consent, or whose risks outweigh the benefits of participating in the study
  7. Subjects with decisional incapacity who are unable to comply with study related visits and procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228758


Contacts
Contact: Maria Marotta-Kollarus, RN 516-663-4652 mkollarus@nyuwinthrop.org
Contact: Mimi Maignan 516-663-4623 wmaignan@nyuwinthrop.org

Locations
United States, New York
NYU WInthrop Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Maria Marotta-Kollarus, RN    516-663-4652    mkollarus@nyuwinthrop.org   
Contact: Mimi Maignan    516-663-4623    wmaignan@nyuwinthrop.org   
Principal Investigator: Stavros N Stavropoulos, MD         
Sub-Investigator: Rani J Modayil, MD         
Sub-Investigator: Mohammad Ali, MD         
Sub-Investigator: Maria Marotta-Kollarus, RN         
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Stavros Stavropoulos, MD NYU WInthrop Hospital

Publications of Results:
Stavropoulos, SN, Modayil, R, and Brathwaite, et al. Anterior vs. posterior per oral endoscopic myotomy (POEM): Is there a difference in outcome? Gastrointest Endosc 2016; 83 (5S): AB145
Friedel D, Modayil R, Stavropoulos SN. Per Oral Endoscopic Myotomy (POEM): review of current techniques and outcomes (including postoperative reflux). Curr Surg Rep 2013; 1: 203-213.
Stranding, S. (2016) Mediastinum, In Gray's anatomy: the anatomical basis of clinical practice. (41st Ed.). (pp. 976-993) Elsevier Limited in Clinical Key Flex

Responsible Party: Stavros Stavropoulos, MD, Chief of Endoscopy Department of Gastroenterology NYU Winthrop Hospital, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT03228758     History of Changes
Other Study ID Numbers: 17008
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stavros Stavropoulos, MD, Winthrop University Hospital:
POEM

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