Prospective Collection of Outcome Data Post POEM-TIF Procedure

NCT04052581 | Withdrawn DMC

• 1 other identifier: IRB00220604
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Achalasia; Gastroesophageal Reflux Disease

Keywords

Per oral Endoscopic Myotomy; Transoral Incisionless Fundoplication; POEM; TIF

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

POEM-TIF

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

Procedure: POEM-TIF

Interventions

POEM-TIF PROCEDURE

Transoral Incisionless Fundoplication (TIF) following Per oral Endoscopic Myotomy (POEM) in the same session

POEM-TIF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Northwell Health: collaborator

MeSH Terms

Conditions

Esophageal Achalasia; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mouen Khashab

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 12, 2019
• Study Start: July 1, 2023
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share