Prospective Collection of Outcome Data Post POEM-TIF Procedure

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04052581
• Other study ID #: IRB00220604
• Status: Withdrawn
• Start date: July 2023
• Est. completion date: July 26, 2023

Study information

• Verified date: July 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 26, 2023
• Est. primary completion date: July 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Achalasia
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Northwell Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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