PREcision MEDicine In Achalasia (PREMEDIA) - Cohort

N/ANot Yet RecruitingNCT07293689

Northwestern University200 enrolled

Overview

The goal of this observational study is to learn about how the doctor decides how long to cut t the esophageal muscle during Per-Oral Endoscopic Myotomy (POEM) in patients with difficulty swallowing due to certain conditions. The main question it aims to answer is: does pre-POEM testing help the physician choose how long to cut the muscle. Participants will allow researchers to access their standard of care information in their medical record, complete questionnaires at up to 6 times over a 2-year period.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Type III Achalasia EGJ Outflow Obstruction With Spastic/Hypercontractile Features Jackhammer Esophagus Distal Esophageal Spasm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 2. Type III achalasia or EGJOO with spastic/hypercontractile features or Jackhammer Esophagus or Distal Esophageal Spasm 3. Eckardt Score \> 3 Exclusion Criteria: * Exclusion: 1. Prior POEM 2. Prior surgical treatment for achalasia 3. Endoscopic pneumatic dilation or lower esophageal sphincter botulinum toxin (botox) injection within 6 months 4. Prior unrelated esophageal or upper gastric surgery, including Roux-en-Y gastric bypass and sleeve gastrectomy 5. Prior endoscopic gastroesophageal intervention for obesity or GERD, such endoscopic sleeve gastroplasty or transoral incisionless fundoplication 6. Known secondary achalasia related to malignancy (pseudoachalasia) 7. Known eosinophilic esophagitis 8. Diverticulum (\> 2 cm) in distal esophagus 9. Megaesophagus 10. Fibroinflammatory stricture of the esophagus due to any etiology (e.g., peptic, radiation, eosinophilic) 11. Pregnancy 12. Standard contraindications to general anesthesia 13. Standard contraindications to endoscopic myotomy in the esophagus (e.g. untreated varices) 14. Unwillingness or inability to consent for the study 15. Anticipated inability to follow protocol

Locations (13)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

University of California San Diego

La Jolla, California, United States

University of Colorado Denver

Denver, Colorado, United States

University of Florida

Gainesville, Florida, United States

Adventist Health System/Sunbelt, Inc

Orlando, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Washington University

St Louis, Missouri, United States

Weill Cornell Medical College

New York, New York, United States

...and 3 more locations

Outcomes

Primary Outcomes

Clinical Response-Overall

Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years.

Time frame: From enrollment to Year 2

Clinical Response-by Sex

Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years.

Time frame: From enrollment to Year 2

Clinical Response-by Race

Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years.

Time frame: From Enrollment to Year 2

Clinical Response-by Ethnicity

Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years.

Time frame: From Enrollment to Year 2

PREcision MEDicine In Achalasia (PREMEDIA) - Cohort

Overview

Conditions

Eligibility

Locations (13)

Outcomes

Primary Outcomes

Central Contacts