Development of Endoscopic Treatment for Achalasia

N/AActive Not RecruitingNCT04180241

Karolinska Institutet55 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Achalasia

Interventions

POEMPROCEDURE

Peroral endoscopic myotomy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Karolinska Institutet, Ersta Hospital

Stockholm, Region Stockholm, Sweden

Karolinska Institutet

Stockholm, Stockholm County Council, Sweden

Outcomes

Primary Outcomes

The proportion of patients who develop gastroesophageal reflux disease (GERD)

Measured as esophageal acid exposure (pH \<4) \> 4% of recorded time

Time frame: 1 year

Secondary Outcomes

Esophageal emptying function

Measured by Time Barium Swallow X-ray

Time frame: 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.

Time frame: 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.

Time frame: 1 year

Dysmotility

measured by Manometry

Time frame: 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

Data from ClinicalTrials.gov

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