Clinical trial NCT01560559: Peroral Endoscopic Myotomy for Primary Esophageal Achalasia
Official title: Peroral Endoscopic Myotomy for Primary Esophageal Achalasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Achalasia
Keywords: Primary esophageal achalasia
endoscopic myotomy
high resolution manometry
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with age less than 18 years old
2. Patients without discernment with legal protection
3. Patients who will not be able to abide with study follow-up as judged by the investigator
4. Patients which cannot provide a written informed consent
5. Patient refusing to participate in the study, without informed consent
6. Pregnant or breastfeeding women, women in fertile age for procreation without efficient contraception, and/or positive serum βHCG test
7. Concomitant participation in other clinical trial
8. S2 sigmoid type primitive achalasia of the cardia
9. Pseudo-achalasia (esophageal carcinoma),
10. History of Barrett's esophagus with or without dysplasia, malignant tumors of the esophagus
11. History of esophageal strictures, systemic sclerosis
12. History of esophageal varices
13. History of endoscopic or surgical therapy of the esophageal achalasia
14. History of inferior endoscopic or surgical esophageal sphincter manipulation (sutures, polymers injection, adhesive bands)
15. History of surgical interventions of the esophagus or stomach (fundoplication, Heller-Dor myotomy, gastric resections, vagotomy with or without gastric drainage)
16. History of congenital of acquired coagulation anomalies: hemorrhagic diseases, hemostasis disturbances (TP \< 60%, TCA \> 40 seconds, platelets \< 60000/mmc)
17. ASA score (American Society of Anaesthesiologists) 3, 4, 5 or 6
18. Cancer, liver, respiratory, renal or heart failure which put the patients in the ASA risk group 3,4,5 or 6.

Primary outcomes:
measure: Percentage of patients with clinically significant perforation
timeFrame: Day 1 after procedure
Secondary outcomes:
measure: percentage of patients with Eckardt score less than 3
timeFrame: at 3rd and 12th month after procedure
measure: significant variation of Eckardt score
timeFrame: at baseline and at 1st, 3rd, 6th and 12th month after the procedure
measure: significant variation of GIQLI score
timeFrame: at baseline and at 1st, 3rd, 6th and 12th month after the procedure
measure: significant variation of high resolution manometry parameters
timeFrame: at baseline and at 3rd month after the procedure
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de Hépatogastroentérologie
Study officials:
affiliation: Hospices Civiles de Lyon
name: Thierry PONCHON, Pr
role: PRINCIPAL_INVESTIGATOR
References: