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Background:
Dumping syndrome is a common complication for patients who have undergone surgery for esophageal cancer. It occurs when food moves too quickly from the stomach (or the reconstructed gastric tube) into the small intestine. This rapid movement causes various symptoms such as bloating, abdominal pain, dizziness, rapid heartbeat, and sweating. Sometimes, it leads to "late dumping," where blood sugar levels drop significantly, causing tremors, cold sweats, and fatigue. Currently, there is no standardized tool to easily diagnose this condition after esophagectomy.
Purpose of the Study:
The objective of this study is to evaluate the effectiveness of Continuous Glucose Monitoring (CGM) in diagnosing dumping syndrome. CGM is a small, wearable sensor that tracks glucose levels in real-time. The investigators aim to determine whether CGM can serve as a valuable tool for the early detection of dumping syndrome in patients who have undergone esophagectomy.
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Agreement Between CGM and OGTT for Dumping Syndrome | The agreement between dumping syndrome diagnosed by the Oral Glucose Tolerance Test (OGTT) and that diagnosed by Continuous Glucose Monitoring (CGM) will be evaluated. Using a predefined glucose cut-off value (e.g., $60\text{ mg/dL}$), the Cohen's Kappa coefficient and its 95% confidence interval will be calculated to assess the level of consistency. A Kappa value of 0.6 or higher is expected to indicate substantial agreement. | Up to 10 days after enrollment, during concurrent OGTT and CGM measurement |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of CGM Using Specific Glucose Cut-off Values | To evaluate the diagnostic performance of CGM relative to the gold standard OGTT, measures of diagnostic accuracy-including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)-will be calculated. Each metric will be reported with its corresponding 95% confidence interval. The analysis will focus on assessing the clinical validity of the 60 mg/dL threshold (or other relevant cutoffs) for detecting dumping syndrome. |
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Inclusion Criteria:
-1. aged 18 or older. 2. people who underwent esophagectomy and gastric tube reconstruction for esophageal cancer.
3. Sigstad score of 7 or higher.
Exclusion Criteria:
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Patients registered at Samsung Medical Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seongyong Park, Ph.D | Contact | +82-10-5388-5715 | syparkcs@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | Gangnam-gu Irwon-Ro 81 | 06351 | South Korea |
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| ID | Term |
|---|---|
| D004377 | Dumping Syndrome |
| ID | Term |
|---|---|
| D011178 | Postgastrectomy Syndromes |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Up to 10 days after enrollment, during concurrent OGTT and CGM measurement |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |