Development of Endoscopic Treatment for Achalasia

Achalasia Clinical Trial

— POEM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04180241
• Other study ID #: 2017/1630-31
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

Procedure:
• POEM
Peroral endoscopic myotomy

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm	Stockholm County Council
Sweden	Karolinska Institutet, Ersta Hospital	Stockholm	Region Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients who develop gastroesophageal reflux disease (GERD)	Measured as esophageal acid exposure (pH <4) > 4% of recorded time	1 year
Secondary	Esophageal emptying function	Measured by Time Barium Swallow X-ray	1 year
Secondary	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
Secondary	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
Secondary	Dysmotility	measured by Manometry	1 year
Secondary	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