Peroral Endoscopic Myotomy (POEM) for Esophageal Motility (POEM)
|ClinicalTrials.gov Identifier: NCT02314741|
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : February 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Achalasia||Procedure: POEM Procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Peroral Endoscopic Myotomy (POEM) for Esophageal Motility in Patients With a Clinical Diagnosis of Achalasia|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Experimental: POEM Treatment Arm
Patients treated with the POEM (per-oral endoscopic myotomy) procedure.
Procedure: POEM Procedure
The procedure is performed under anesthesia.The procedure involves endoscopic electrosurgical dissection with an Olympus triangular tip knife.The myotomy is usually ~6cm long & averages 8-10cm. After the myotomy is performed the scope is withdrawn & inserted into the lumen to inspect the mucosa, ensure mucosal integrity & confirm easy passage of the endoscope through the LES consistent with an adequate myotomy. The mucosal entry site is usually 2-3cm long, & is closed with 5-10 endoscopic clips. Patients are hospitalized after procedure for observation.The patient is given IV-nutrition until post-operative day 1. An esophagram is obtained. If no loss of mucosal integrity or leak is noted, a liquid diet is started, which is continued for several days before initiating a solid diet.
- Gather Standardized Data on Patients with Achalasia Who Have Been Treated with the POEM Procedure [ Time Frame: About 12 months ]The primary aim of this study is to assess safety and efficacy in the adoption of the POEM procedure compared to the typical Heller Myotomy used for the treatment of achalasia using standardized methods, including esophageal manometry, pre- and post- procedure barium swallow studies, as well as standardized measures of dysphagia symptoms due to achalasia (the Eckart score), and patient's medical records and self-reported symptoms.
- Pre-Procedure versus Post-Procedure Barium Swallow Results in POEM Patients [ Time Frame: About 6 Months ]Assess POEM procedure's efficacy as defined by improvement of barium swallow study and dysphagia symptoms associated with achalasia. Barium swallow study will compare pre- and post-operative esophageal emptying.
- Pre-Procedure Versus Post-Procedure Eckart Score Results in POEM Patients [ Time Frame: About 6 Months ]Assess POEM procedure's efficacy as defined by improvement of dysphagia symptoms associated with achalasia. Dysphagia improvement will be assessed using a pre- and post-surgical standardized dysphagia scoring system known as an Eckart Score.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314741
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Vinay Chandrasekhara, MD||University of Pennsylvania|
|Principal Investigator:||Gregory G Ginsberg, MD||University of Pennsylvania|
|Principal Investigator:||Gary W Falk, MD, MS||University of Pennsylvania|
|Principal Investigator:||Michael Kochman, MD||University of Pennsylvania|
|Principal Investigator:||David C Metz, MD||University of Pennsylvania|