Prospective Collection of Outcome Data Post POEM-TIF Procedure

Johns Hopkins University

Status: Withdrawn

Conditions: Achalasia; Gastroesophageal Reflux Disease

Treatments: Procedure: POEM-TIF

Study type: Observational

Funder types: Other

Identifiers

NCT04052581

IRB00220604

Details and patient eligibility

About

Per Oral Endoscopic Myotomy has been established as a safe and effective treatment of Achalasia type I and II; however, it is limited by post-procedure gastroesophageal reflux. Transoral Incisionless Fundoplication (TIF) has been introduced as the endoscopic gold standard for anti-reflux procedure. Recently, combined POEM-TIF has been performed successfully as a standard of care treatment for patients with severe GER after POEM. We aim to study the safety and feasibility of performing POEM-TIF (POEM and TIF in the same endoscopic session). This study will also put the groundwork for a randomized clinical trial to further study the clinical outcome of the POEM-TIF procedure.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient age greater than 18 years old
• Manometrically proven diagnosis of either type I or type II achalasia.

Exclusion criteria

• Achalasia type III, or other esophageal dysmotility disorders.
• Completion of POEM with evidence of mucosal injury or compromise
• Previous surgery of the stomach such as sleeve gastrectomy, gastric bypass, Heller myotomy, partial or complete fundoplication, or partial/complete gastrectomy
• Esophageal lumen diameter greater than 4 cm
• Sigmoidization of the esophagus
• Large esophageal diverticula
• Known active gastroesophageal malignancy
• Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
• Cirrhosis with portal hypertension, varices, and/or ascites
• Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
• Acute gastrointestinal bleeding
• Uncorrectable coagulopathy defined by international normalized ratio (INR) > 1.5 or platelet < 50,000

Trial design

0 participants in 1 patient group

POEM-TIF

Description:

All participants will undergo the POEM-TIF in the same session.

Treatment:

Procedure: POEM-TIF