Peroral Endoscopic Myotomy (POEM) for Esophageal Motility

Completed · Not applicable

Conditions studied: Achalasia

In brief

The investigators wish to monitor the adoption of a new, incisionless approach to performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic Myotomy (POEM), will provide less-invasive treatment for esophageal achalasia, ideally providing similar if not better outcomes (safety and efficacy) as the Heller myotomy. The investigators hope to enroll 10 patients with a clinical diagnosis of achalasia who meet inclusion criteria. The POEM procedure has been done in many hospitals without any research associated with it. Dr. Ginsberg, Dr. Chandrasekhara and Dr. Kochman will perform the procedures after being trained. Dr. Ginsberg has personally witnessed the performance of 10 POEM procedures and has performed in a swine model. The PI is credentialed to initiate POEM at HUP with the first case to be proctored by an experienced operator. The PI will then proctor the other adopters. The investigators would like to evaluate the safety of it and the effectiveness of it. The investigators will use their symptom scores and radiology tests pre- and post-POEM to evaluate effectiveness.

Key facts

Study ID

NCT02314741

Run by

University of Pennsylvania

People needed

10

Starts

2014-05-01

Expected to finish

2015-05-01

Last updated by the study team

2018-02-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > or = to 18 years of age
• Clinical diagnosis of achalasia
• A candidate for Heller myotomy
• Esophageal manometry and barium esophogram with findings supportive of achalasia diagnosis
• Women of childbearing potential: negative urine pregnancy test
• Able to undergo general anesthesia
• Willing and able to give informed consent

You may not qualify if…

• < 18 years of age
• Pregnancy
• Previous mediastinal or esophageal surgery
• Contraindications for esophagogastroduodenoscopy
• Presence of malignancy
• Coagulopathy (INR 1.5)
• Thrombocytopenia (platelet count < 100K/microliter)
• ASA Score > Class II
• History of mental illness
• Any medical conditions as determined by the PI to be a contraindication to the procedure
• Unable to give informed consent

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.