A Clinical Study of Per Oral Endoscopic Myotomy (POEM) in Patients Suffering From Achalasia

NCT01692106 | Completed

• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the feasibility of endoscopic myotomy for achalasia. In achalasia, there is loss of relaxation of the lower esophageal sphincter (LES), as well as a higher baseline pressure in the LES. The most widespread treatment for this disease and the one that has the best long term results involves cutting the muscle layers of the lower esophagus and on the neighbouring stomach without injurying the underlying mucosa or inner layer of the esophageal wall. This is done during a surgery through the abdomen either with a big incision or more recently with the keyhole technique. This surgery has various potential complications, one of which being making a hole through the mucosa or not extending the cut on the muscle long enough to obtain adequate relaxation of the sphincter. The per oral endoscopic myotomy (POEM) is a new intervention that is done also under general anesthesia in the operating room; however, it involves no skin incisions and all the procedure is done through a fiber optic camera. It involves making a cut in the inner layer of the esophagus and then with cautery cut the muscle fibers responsible of the blockage and finally closing the initial opening with clips. In this study we will investigate the feasibility of this intervention both from a technical aspect as well as a logistical perspective given the local operating room constraints.

Conditions

Achalasia

Keywords

Heller myotomy

Outcome Measures

Primary Outcomes (1)

• feasibility of the POEM procedure in achalasia

  Patients will be consecutively evaluated on effectiveness of the endoluminal procedure by conducting standard diagnostics including postoperative gastrografin swallow. After 6 months standard esophagogastroduodenoscopy (EGD), high-resolution manometry and pH impedance will be done and a Quality of Life questionnaire will be filled out. Results will be compared to historical data of 40 conventional laparoscopic Heller myotomies.

  1-6 months

Secondary Outcomes (1)

• complications

  1-6 months

Study Arms (1)

peroral endoscopic myotomy (POEM)

EXPERIMENTAL

The Procedure: per oral endoscopic myotomy (POEM)will be performed on all patients in this single arm study.

Procedure: Procedure: Per Oral Endoscopic Myotomy (POEM)

Interventions

Procedure: Per Oral Endoscopic Myotomy (POEM) PROCEDURE

lower esophageal sphincter muscle is sectioned through an unique endoscopic approach.

peroral endoscopic myotomy (POEM)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidate for a Heller myotomy
• No contra-indication to general anesthesia
• Their age is ≥18 years and ≤80 years
• Able to give written consent

You may not qualify if:

• Previous intervention for achalasia: any of previous Heller myotomy, Botox injections, endoscopic myotomy
• Previous mediastinal surgery
• Any anatomical esophageal anomaly that in the opinion of the investigator may render the intervention more difficult, such as sigmoid esophagus on the pre-operative barium swallow or hiatal hernia \> 2cm.
• Body mass index (BMI) \> 40
• Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
• Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Dennis Hong, MD

  St. Josephs' Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Dennis Hong, Principal Investigator

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 25, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

CA (1)