Gastroesophageal Reflux Disease : GERD
Conditions
Interventions
Acid-suppressive medications are discontinued for 14 days prior to the Temporary Narrowing Test (TNT), after which self-administered symptom questionnaires are obtained. During TNT, narrowing of the
Sponsors
Hiroshima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Individuals aged 18 years or older at the time of obtaining informed consent. Individuals with symptoms of GERD, including typical symptoms such as heartburn and acid regurgitation, as well as atypical symptoms such as chest pain, chronic cough, and laryngitis. Individuals who desire and are scheduled to undergo endoscopic antireflux mucosal resection, including those with a history of prior treatments. Individuals who are able to provide written informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: Individuals who are unable to undergo pre treatment evaluations, including upper gastrointestinal endoscopy, esophageal manometry, and 24 hour pH impedance monitoring. Individuals for whom completion of self administered symptom questionnaires is difficult. Individuals who are unable to discontinue acid suppressive medications, including proton pump inhibitors, potassium competitive acid blockers, and H2 receptor antagonists. Individuals who are pregnant or may be pregnant. Individuals deemed inappropriate for participation in this study by the principal investigator or co investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between changes in symptom scores (GERD-HRQL, GerdQ, and FSSG) from baseline at 3 days after the Temporary Narrowing Test and at 8 weeks after endoscopic antireflux mucosal resection. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Procedure time and technical success rate of the Temporary Narrowing Test The Temporary Narrowing Test (TNT) is an endoscopic procedure in which the mucosa of the gastric cardia is approximated using endoscopic clips. This outcome was evaluated to assess the feasibility and potential standardization of the procedure. Procedure time was defined as the interval from insertion of the first endoscopic clip into the endoscope to completion of mucosal plication at the gastric cardia. Technical success was defined as successful narrowing of the gastric cardia achieved by approximating the anterior and posterior walls using endoscopic clips. The technical success rate was defined as the proportion of technically successful cases among all enrolled patients. 2. Incidence of TNT related adverse events TNT related adverse events were defined as newly developed or worsened symptoms after TNT for which an association with TNT could not be excluded and were assessed to evaluate procedural safety. Bleeding was defined as bleeding from the TNT site requiring endoscopic hemostasis blood transfusion or other intervention or a decrease in hemoglobin level of 2.0 g per dL or more from baseline. Mucosal laceration was defined as a TNT related mucosal tear measuring 10 mm or more in length. Passage disturbance was defined as subjective symptoms such as dysphagia or a sensation of food impaction. 3. TNT maintenance rate and clip retention rate Although clips placed during TNT are expected to detach spontaneously they may remain at the time of endoscopic antireflux mucosal resection and require removal therefore these outcomes were evaluated. TNT maintenance was defined as retention of all placed clips with preserved mucosal narrowing. Clip retention was defined as the presence of one or more remaining clips. Both rates were calculated as proportions among all enrolled patients. | — |
Countries
Japan
Contacts
Public ContactHidenori Tanaka
Hiroshima University Hospital, Hiroshima, Japan Endoscopy Center
Outcome results
None listed