Prospective Collection of Outcome Data Post POEM-TIF Procedure

Assessment of Safety and Outcomes in Patients Undergoing a Standard-of-care Combined POEM-TIF Procedure

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.

Study Overview

• Status: Withdrawn
• Conditions: Gastroesophageal Reflux Disease; Achalasia
• Intervention / Treatment: Procedure: POEM-TIF

• Study Type: Observational

Contacts and Locations

• Study Contact: Name: Mouen Khashab; Phone Number: 443-287-1960; Email: mkhasha1@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patient age > 18 years old who have been diagnosis with either type I or type II Achalasia that has been proved by manometry

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
POEM-TIF; All participants will undergo the POEM-TIF in the same session.	Procedure: POEM-TIF; Transoral Incisionless Fundoplication (TIF) following Per oral Endoscopic Myotomy (POEM) in the same session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of POEM-TIF as assessed by the American Society of Gastrointestinal Endoscopy (ASGE) lexicon scoring system	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.	6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Northwell Health
• Investigators: Principal Investigator: Mouen Khashab, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Actual): July 26, 2023
• Study Completion (Actual): July 26, 2023

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: POEM; TIF; Transoral Incisionless Fundoplication; Per oral Endoscopic Myotomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: IRB00220604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No