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Active, Not Recruiting

NCT Number: NCT04180241

Development of Endoscopic Treatment for Achalasia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Achalasia Deglutition Disorders Digestive System Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet, Ersta Hospital, Stockholm, Region Stockholm, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

POEM

Procedure

Peroral endoscopic myotomy

Primary outcomes

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

    Time frame: 1 year

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

Secondary outcomes

  1. Esophageal emptying function

    Time frame: 1 year

    Measured by Time Barium Swallow X-ray

  2. Eckardt score

    Time frame: 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.

  3. RAND-36

    Time frame: 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.

  4. Dysmotility

    Time frame: 1 year

    measured by Manometry

  5. Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: POEM

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Nov 27, 2019
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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