Prospective Collection of Outcome Data Post POEM-TIF Procedure

NCT ID: NCT04052581

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2023-07-26

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

POEM-TIF

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

POEM-TIF

Intervention Type: PROCEDURE

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

Interventions

POEM-TIF

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mouen Khashab

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Other Identifiers

IRB00220604

Identifier Type: -

Identifier Source: org_study_id