Peroral Endoscopic Myotomy for Primary Esophageal Achalasia

NCT01560559 | Completed Phase 3 DMC

• 1 other identifier: 2011.696
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Recommended therapies for esophageal achalasia are endoscopic pneumatic dilation and Heller-Dor surgical myotomy. Endoscopic myotomy has been recently proposed in human patient in expert centers in Japan, US and Germany. In theory, endoscopic myotomy is as effective as surgical myotomy but less invasive and more effective with less complications than endoscopic pneumatic dilation. Up to now, published studies have confirmed these expectations, with 100% efficacy and no clinically significant complications. The present clinical trial with study the security and efficacy of peroral endoscopic myotomy in primary achalasia patients.

Conditions

Primary Achalasia

Keywords

Primary esophageal achalasia; endoscopic myotomy; high resolution manometry

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with clinically significant perforation

  Clinically significant perforation is defined as an ensemble of procedural, clinical, biological and imaging parameters: * perforation seen during procedure with placement of endoscopic metallic clips as closing method * acute severe persistent pain, fever over 38.5°C, subcutaneous emphysema, pneumomediastinum, penumoperitoneum * elevated white blood count with elevated neutrophils and elevated CRP, ascending values * subcutaneous emphysema, pneumomediastinum, penumoperitoneum seen at imaging studies (day 1 CT scan)

  Day 1 after procedure

Secondary Outcomes (4)

• percentage of patients with Eckardt score less than 3

  at 3rd and 12th month after procedure

• significant variation of Eckardt score

  at baseline and at 1st, 3rd, 6th and 12th month after the procedure

• significant variation of GIQLI score

  at baseline and at 1st, 3rd, 6th and 12th month after the procedure

• significant variation of high resolution manometry parameters

  at baseline and at 3rd month after the procedure

Study Arms (1)

Single Arm

EXPERIMENTAL

Peroral endoscopic myotomy

Procedure: Peroral endoscopic myotomy

Interventions

Peroral endoscopic myotomy PROCEDURE

An endoscopy is performed under anesthesia with orotracheal intubation. After submucosal saline injection, an entry point in the submucosal space is created at 10 cm above the cardia. The endoscope will create a 12cm long tunnel in the caudal direction by submucosal dissection, stopping at 2cm below cardia. Then the muscular circular internal layer is sectioned on a 9cm length, starting 3 cm below the submucosal entry point. At the end the submucosal entry point is closed with metallic clips. A scanner is performed after the procedure so as to check the esophageal wall integrity. Alimentation is progressively introduced at day 1. This is a study of a procedure - peroral endoscopic myotomy (POEM). No new, unapproved device is used. All endoscopic tools are already approved for endoscopic submucosal dissection and associated complications (hemorrhage or perforation): dissection knifes, hot biopsy forceps, endoscopic metallic clips.

Single Arm

Eligibility Criteria

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

You may qualify if:

• Patients of both sexes aged over 18 years old
• Patients who have signed the informed consent form before any study related procedure
• Primary achalasia of the cardia with Eckardt score \> 3
• Non sigmoid achalasia or S1 sigmoid type achalasia at barium meal Rx study
• ASA score (American Society of Anaesthesiologists) 1 or 2
• Patients affiliated to a social security health system

You may not qualify if:

• Patients with age less than 18 years old
• Patients without discernment with legal protection
• Patients who will not be able to abide with study follow-up as judged by the investigator
• Patients which cannot provide a written informed consent
• Patient refusing to participate in the study, without informed consent
• Pregnant or breastfeeding women, women in fertile age for procreation without efficient contraception, and/or positive serum βHCG test
• Concomitant participation in other clinical trial
• S2 sigmoid type primitive achalasia of the cardia
• Pseudo-achalasia (esophageal carcinoma),
• History of Barrett's esophagus with or without dysplasia, malignant tumors of the esophagus
• History of esophageal strictures, systemic sclerosis
• History of esophageal varices
• History of endoscopic or surgical therapy of the esophageal achalasia
• History of inferior endoscopic or surgical esophageal sphincter manipulation (sutures, polymers injection, adhesive bands)
• History of surgical interventions of the esophagus or stomach (fundoplication, Heller-Dor myotomy, gastric resections, vagotomy with or without gastric drainage)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Clinique de Hépatogastroentérologie

Lyon, 69003, France

Location

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Thierry PONCHON, Pr

  Hospices Civiles de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 22, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 25, 2015

Record last verified: 2012-03

Locations

FR (1)