Development of Endoscopic Treatment for Achalasia

Study Overview
=================
Brief Summary
-----------------
Per Oral Endoscopic Myotomy (POEM); comparison of two surgical techniques division all the esophageal muscle layers versus division the inner circular muscle layer of the esophagus only.

Detailed Description
-----------------
Prior to surgery, all patients undergo upper endoscopy , x-ray time barium manometry, 24 hours pH registration. Moreover Quality of Life instrument (RAND-36), GSRS (Gastrointestinal Symptom Rating Scale) and a dysphagia score (Eckardt score) are completed by all patients. Follow-up with surveys 3, 6, 12, and 36 months (GSRS, RAND-36 and Eckardt score). At 3,12 and 36 months an x-ray time barium is performed and after 12 months a gastroscopy and at 24 hours esophageal pH monitoring are performed.

Official Title
-----------------
Development of Endoscopic Treatment for Achalasia, POEM (Per Oral Esophageal Myotomy): A Randomized Controlled Trial

Conditions
-----------------
Achalasia

Intervention / Treatment
-----------------
* Procedure: POEM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed achalasia the patient should understand the nature and the purpose of the study and give informed consent Exclusion Criteria: previous surgical treatment of achalasia inability to understand the contents of or follow the protocol other pathology as an explanation for the obstruction of the esophageal transition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: POEM with division all the esophageal muscle layers compared to deviding only the inner circular muscle layer of the esophagus.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: total division of the muscle layer<br>POEM- total division of the circular muscle layer into the gastroesophageal junction | Procedure: POEM<br>* Peroral endoscopic myotomy<br>|
| Active Comparator: partial division of the muscle layer<br>POEM - partial division of the circular muscle layer into the gastroesophageal junction | Procedure: POEM<br>* Peroral endoscopic myotomy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who develop gastroesophageal reflux disease (GERD) | Measured as esophageal acid exposure (pH <4) > 4% of recorded time | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal emptying function | Measured by Time Barium Swallow X-ray | 1 year | 
| Eckardt score | The Eckardt score consists of 4 components including dysphagia, chest pain, regurgitation, and weight loss.Each component is assigned a score from 0 to 3 based on the patient's self-reported response, resulting in a total score that can vary from 0 to 12, higher scores mean a worse outcome. | 1 year | 
| RAND-36 | The RAND-36 It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales. higher scores mean a better outcome. | 1 year | 
| Dysmotility | measured by Manometry | 1 year | 
| Gastrointestinal Symptom Rating Scale (GSRS) | Scoring;The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one. A mean value for the items in each dimension should be calculated: Diarrhoea syndrome: 11. Increased passage of stools 12. Loose stools 14. Urgent need for defecation Indigestion syndrome: 6. Borborygmus 7. Abdominal distension 8. Eructation 9. Increased flatus Constipation syndrome: 10. Decreased passage of stools 13. Hard stools 15. Feeling of incomplete evacuation Abdominal pain syndrome: 1. Abdominal pain 4. Sucking sensations 5. Nausea and vomiting Reflux syndrome: 2. Heartburn 3. Acid regurgitation | 1 year |