Prospective Collection of Outcome Data Post POEM-TIF Procedure

Withdrawn

• Conditions: Achalasia; Gastroesophageal Reflux Disease
• Interventions: Procedure: POEM-TIF

• Registration Number: NCT04052581
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-12
• Status Verified: 2023-07
• Study Start: 2023-07
• Primary Completion: 2023-07-26
• Study Completion: 2023-07-26
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety of POEM-TIF as assessed by the American Society of Gastrointestinal Endoscopy (ASGE) lexicon scoring system	6 months	Safety will be evaluated by the frequency of severe adverse events with probable or definite attribution to the procedure based the ASGE lexicon scoring system. ASGE lexicon's severity grading system classify the adverse events into one of the four categories of mild, moderate, severe, and fatal. Mild adverse event means an adverse event that result in (1) Procedure aborted (or not started) because of an adverse event, (2) Post-procedure medical consultation, or (3) Unplanned hospital admission or prolongation of hospital stay for lesser or equal to 3 nights. Fatal grade adverse event happens when the procedure cause death.