Continous Glucose Measurement, Dumping Syndrome, Esophagectomy
Conditions
Keywords
esophagectomy, dumping syndrome
Brief summary
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.
Interventions
None listed
Sponsors
Samsung Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 1\. Diabetes with autonomic neuropathy. 2. Inability to complete the diagnostic procedure (e.g., cognitive decline). 3. Refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Agreement Between CGM and OGTT for Dumping Syndrome | Up to 10 days after enrollment, during concurrent OGTT and CGM measurement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy of CGM Using Specific Glucose Cut-off Values | Up to 10 days after enrollment, during concurrent OGTT and CGM measurement | 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. |
Countries
South Korea
Contacts
CONTACTSeongyong Park, Ph.D
Outcome results
None listed