Development of Endoscopic Treatment for Achalasia
- Conditions
- Achalasia
- Interventions
- Procedure: POEM
- Registration Number
- NCT04180241
- Lead Sponsor
- Karolinska Institutet
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 55
- Newly diagnosed achalasia
- the patient should understand the nature and the purpose of the study and give informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description total division of the muscle layer POEM POEM- total division of the circular muscle layer into the gastroesophageal junction partial division of the muscle layer POEM POEM - partial division of the circular muscle layer into the gastroesophageal junction
- Primary Outcome Measures
Name Time Method The proportion of patients who develop gastroesophageal reflux disease (GERD) 1 year Measured as esophageal acid exposure (pH \<4) \> 4% of recorded time
- Secondary Outcome Measures
Name Time Method Eckardt score 1 year 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.
Esophageal emptying function 1 year Measured by Time Barium Swallow X-ray
RAND-36 1 year 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.
Dysmotility 1 year measured by Manometry
Gastrointestinal Symptom Rating Scale (GSRS) 1 year 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
Trial Locations
- Locations (2)
Karolinska Institutet, Ersta Hospital
🇸🇪Stockholm, Region Stockholm, Sweden
Karolinska Institutet
🇸🇪Stockholm, Stockholm County Council, Sweden