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Prospective Collection of Outcome Data Post POEM-TIF Procedure

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Johns Hopkins University

Status

Withdrawn

Conditions

Achalasia
Gastroesophageal Reflux Disease

Treatments

Procedure: POEM-TIF

Study type

Observational

Funder types

Other

Identifiers

NCT04052581
IRB00220604

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

POEM-TIF
Description:
All participants will undergo the POEM-TIF in the same session.
Treatment:
Procedure: POEM-TIF

Trial contacts and locations

0

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Central trial contact

Mouen Khashab

Data sourced from clinicaltrials.gov

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