Development of Endoscopic Treatment for Achalasia (POEM)

Karolinska Institute

Status: Active, not recruiting

Conditions: Achalasia

Treatments: Procedure: POEM

Study type: Interventional

Funder types: Other

Identifiers

NCT04180241

2017/1630-31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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55 participants in 2 patient groups

total division of the muscle layer

Active Comparator group

Description:

POEM- total division of the circular muscle layer into the gastroesophageal junction

Treatment:

Procedure: POEM

partial division of the muscle layer

Active Comparator group

Description:

POEM - partial division of the circular muscle layer into the gastroesophageal junction

Treatment:

Procedure: POEM