Peroral Endoscopic Myotomy (POEM) for Esophageal Motility

Summary

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.

Conditions

• Achalasia

Interventions

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 After the myotomy is performed the scope is withdrawn \& inserted into the lumen to inspect the mucosa, ensure mucosal integrity \& confirm easy passage of the endoscope through the LES consistent with an adequate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.

Sponsors & Collaborators

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Vinay Chandrasekhara, MD · University of Pennsylvania

• Gregory G Ginsberg, MD · University of Pennsylvania

• Gary W Falk, MD, MS · University of Pennsylvania

• Michael Kochman, MD · University of Pennsylvania

• David C Metz, MD · University of Pennsylvania

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-05-31

Primary Completion

2015-05-31

Completion

2015-05-31

Countries

• United States

Study Locations