Peroral Endoscopic Myotomy (POEM) for Esophageal Motility

Achalasia Clinical Trial

— POEM  

Official title:

Peroral Endoscopic Myotomy (POEM) for Esophageal Motility in Patients With a Clinical Diagnosis of Achalasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314741
• Other study ID #: 819130
• Status: Completed
• Phase: N/A
• First received: July 17, 2014
• Last updated: February 16, 2018
• Start date: May 2014
• Est. completion date: May 2015

Study information

• Verified date: February 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

An esophageal motility disorder is when muscular contractions become discoordinated or weak and interfere with movement of food down the esophagus. Some esophageal motility disorders persist long enough to cause severe problems requiring surgical intervention. Achalasia, one subtype of esophageal motility disorder that is a rare disease, can be defined by the esophageal sphincter and muscle unable to relax or dilate. Left untreated, symptoms such as difficulty swallowing, regurgitation, heartburn, and chest pain may easily turn into complications such as severe weight loss, malnutrition, coughing, pulmonary infection, pneumonia, and perforation of the esophagus. Diagnosis of esophageal achalasia can be determined by esophageal manometry and/or barium swallow esophagram. Treatment for achalasia includes balloon dilation, botulinum toxin injection and surgical intervention. Balloon dilation is performed by inserting a balloon through the esophageal sphincter, inflating the balloon, disrupting the esophageal muscle. Botox has also been known to successfully relax spastic muscle contractions of achalasia through direct injection into the esophageal muscle. Unfortunately, each alternative to surgical treatment often requires repeated administration to improve the symptoms of achalasia. Traditional treatment of achalasia has included open abdominal or thoracic surgical procedures to cut valve muscles between the esophagus and stomach (Heller Myotomy). Laparoscopic multi-port Heller myotomies have become the preferred approach, requiring 4 smaller abdominal incisions for placement of laparoscope equipment. Results of this laparoscopic technique have proven that although 2/3 of the patient population was successfully treated, a subset of this group still need repeat surgical procedures or balloon dilation. Recently, single-incision laparoscopic Heller myotomies have produced favorable results, with a single umbilical incision preferential to multiple-incision laparoscopy. We propose adoption of a new, incisionless approach to performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic Myotomy (POEM) is expected to provide a less-invasive treatment for esophageal achalasia, ideally providing similar if not better outcomes as the Heller myotomy and can be adopted safely and effectively at Penn Medicine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• < 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

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gather Standardized Data on Patients with Achalasia Who Have Been Treated with the POEM Procedure	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.	About 12 months
Secondary	Pre-Procedure versus Post-Procedure Barium Swallow Results in POEM Patients	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.	About 6 Months
Secondary	Pre-Procedure Versus Post-Procedure Eckart Score Results in POEM Patients	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.	About 6 Months