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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK131317-01A1 | U.S. NIH Grant/Contract | View source | |
| 2025P013181 | Other Identifier | Emory IRB |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The prospective clinical trial will study muscle fibrosis in relation to lower esophageal sphincter (LES) measurements on Functional Lumen Imaging Probe (FLIP) Topography (the novel technology that utilizes impedance planimetry) after pharmacologic challenge. A better understanding of achalasia will allow intervention at an earlier stage.
Achalasia is a disease characterized by inadequate opening of the lower esophageal sphincter. Achalasia is presumed to be due to neuronal dysfunction (active), however there are other variables such as muscle layer fibrosis (passive) that may contribute, particularly in milder or earlier achalasia variants. A new technology, impedance planimetry, may be able to measure active vs passive features of the lower esophageal sphincter (LES).
The prospective clinical trial will study muscle fibrosis in relation to lower esophageal sphincter (LES) measurements on Functional Lumen Imaging Probe (FLIP) Topography (the novel technology that utilizes impedance planimetry) after pharmacologic challenge. A better understanding of achalasia will allow intervention at an earlier stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacologic challenge | Experimental | Measurement of esophageal response to atropine using functional lumen imaging probe (FLIP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine challenge | Drug | Atropine challenge. After baseline FLIP, subjects will be administered 15 mcg/kg of intravenous atropine. Two minutes after administration, FLIP will be repeated. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of lower esophageal sphincter contraction and relaxation | Degree of lower esophageal sphincter contraction and relaxation will be measured | Two minutes after the study drugs administration |
| The collagen content in muscle biopsy specimens | The collagen content in muscle biopsy specimens will be measured on Sirius Red and Masson Trichrome staining. | Two minutes after the study drugs administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anand Jain, MD | Contact | 404-778-3184 | anand.jain@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anand Jain, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States | |
| Emory Saint Joseph's Hospital |
Esophageal function testing data, symptom questionnaire data, treatments performed, and biospecimen analysis results will be shared.
Estimated January 2025.
Collaborators with whom the study team has Data Use Agreements in Place will have access through secure electronic means.
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| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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Patients will have the option of consenting for Aim 1(pharmacologic challenge ), Aim 2 (in the event they go for future myotomy) or both if they choose to be included in the study.
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| Esophageal muscle biopsy | Procedure | Esophageal muscle biopsy. During standard-of-care Heller myotomy or per-oral endoscopic myotomy, 5mm of lower esophageal sphincter and distal esophageal circular muscle will be collected via biopsy forceps. |
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| Recruiting |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| D004066 | Digestive System Diseases |