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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by McMaster University
Sponsor:
Information provided by (Responsible Party):
Dennis Hong MD, McMaster University
ClinicalTrials.gov Identifier:
NCT01692106
First received: September 19, 2012
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Achalasia
Procedure: Procedure: Per Oral Endoscopic Myotomy (POEM)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Study of Per Oral Endoscopic Myotomy (POEM) in Patients Suffering From Achalasia.

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • feasibility of the POEM procedure in achalasia [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • complications [ Time Frame: 1-6 months ] [ Designated as safety issue: Yes ]
    post-operative complications, intra-operative outcomes as well as the Eckardt's grading systems of symptom severity and reflux grading secondary to achalasia.


Estimated Enrollment: 10
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: peroral endoscopic myotomy (POEM)
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)
lower esophageal sphincter muscle is sectioned through an unique endoscopic approach.

Detailed Description:

All patients will have routine pre-operative EGD, manometry, barium swallow, ph-metry. Equally all patients will undergo Eckardt's and grading systems of symptom severity before and after the intervention. The patients will have a gastro-graffin swallow in the first day after the surgery.

Procedure: Under general anesthesia upper endoscopy is performed using a standard single channel gastroscope. Submucosal injection with 10 ml saline with 1% methylen blue at the level of the mid esophagus is initially performed. A small longitudinal submucosal incision is created using a standard needle knife. For a sufficient entry point as well as submucosal tunnel, a dilating balloon is inserted submucosally via the created incision similar to the technique used in standard endoscopic submucosal dissection. The balloon is slightly inflated to allow sufficient entrance of the endoscope. The gastroscope is advanced into the submucosal space and the tunnel is created via needle knife or blunt dissection as appropriate. The tunnel is created distally and is stopped several centimeters beyond the lower esophageal sphincter (LES), which can easily be identified. Using flexible scissors, a triangle tip- or respectively an isolated tip-knife the clearly visible circular muscles are divided starting 4 cm above the LES extending 2 cm beyond the previously identified esophageal border. The longitudinal and serosal layers are left intact. Finally the mucosal entry is closed with standard endoscopic clips. Patients will receive standard postoperative care for surgical myotomy, including long-term follow-up.

If for any reason the endoscopic treatment is unable to be completed or infeasible, a standard laparoscopic treatment will be performed.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692106

Locations
Canada, Ontario
St. Joseph's Healthcare Not yet recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Radu Pescarus, MD       radupes@yahoo.com   
Principal Investigator: Dennis Hong, MD         
Sub-Investigator: Radu Pescarus, MD         
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Dennis Hong, MD St. Josephs' Healthcare Hamilton
  More Information

No publications provided

Responsible Party: Dennis Hong MD, Dr. Dennis Hong, Principal Investigator, McMaster University
ClinicalTrials.gov Identifier: NCT01692106     History of Changes
Other Study ID Numbers: TBD
Study First Received: September 19, 2012
Last Updated: September 20, 2012
Health Authority: Canada: Public Health Agency of Canada
Canada: Ethics Review Committee

Keywords provided by McMaster University:
Heller myotomy

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 16, 2014