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The study is not relevant anymore.
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| Name | Class |
|---|---|
| Northwell Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POEM-TIF | All participants will undergo the POEM-TIF in the same session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POEM-TIF | Procedure | Transoral Incisionless Fundoplication (TIF) following Per oral Endoscopic Myotomy (POEM) in the same session |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patient age > 18 years old who have been diagnosis with either type I or type II Achalasia that has been proved by manometry
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| Name | Affiliation | Role |
|---|---|---|
| Mouen Khashab | Johns Hopkins University | Principal Investigator |
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| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| D004066 | Digestive System Diseases |