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

Completed · Not applicable

Conditions studied: Achalasia

In brief

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.

Key facts

Study ID

NCT03228758

Run by

NYU Langone Health

People needed

89

Starts

2017-07-24

Expected to finish

2019-05-24

Last updated by the study team

2020-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Subjects who are willing and competent to sign Informed Consent and to comply with study related visits and procedures.

You may not qualify if…

• Subjects who are under 18 years of age
• 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
• Subjects diagnosed with other motility disorders such as distal esophageal spasm (DES), hypertensive peristalsis (Nutcracker), or hypercontractile esophagus (Jackhammer)
• Subjects with coagulopathy
• Pregnant females
• 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
• Subjects with decisional incapacity who are unable to comply with study related visits and procedures

Where it is running

• NYU Winthrop Hospital — Mineola, New York, United States

Full record on ClinicalTrials.gov

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