Development of Endoscopic Treatment for Achalasia (POEM)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Achalasia
• Intervention / Treatment: Procedure: POEM

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Region Stockholm
    • Stockholm, Region Stockholm, Sweden, SE-116 91
      • Karolinska Institutet, Ersta Hospital
  • Stockholm County Council
    • Stockholm, Stockholm County Council, Sweden, 116 91
      • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Anders Thorell, Professor, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophageal Achalasia
• Other Study ID Numbers: 2017/1630-31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No