Dumping Syndrome After Esophagectomy
Prospective Observational Study on the Utility of Continuous Glucose Monitoring for the Diagnosis of Dumping Syndrome After Esophagectomy
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Seongyong Park, Ph.D
- Telefonnummer: +82-10-5388-5715
- E-mail: syparkcs@gmail.com
Studiesteder
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Gangnam-gu Irwon-Ro 81
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Seoul, Gangnam-gu Irwon-Ro 81, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Diagnostic Agreement Between CGM and OGTT for Dumping Syndrome
Tidsramme: Up to 10 days after enrollment, during concurrent OGTT and CGM measurement
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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.
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Up to 10 days after enrollment, during concurrent OGTT and CGM measurement
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Diagnostic Accuracy of CGM Using Specific Glucose Cut-off Values
Tidsramme: Up to 10 days after enrollment, during concurrent OGTT and CGM measurement
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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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Up to 10 days after enrollment, during concurrent OGTT and CGM measurement
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SMC-2025-06-033
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Dumping syndrom
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University Hospital, Basel, SwitzerlandAfsluttetBariatrisk kirurgi | Postprandial hypoglykæmi | Sen dumping syndromSchweiz
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Radboud University Medical CenterUkendt
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Technological Educational Institute of ThessalyRekruttering
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Universitaire Ziekenhuizen KU LeuvenIpsenAfsluttet
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Novartis PharmaceuticalsAfsluttetDumping syndromBelgien, Holland, Tyskland, Frankrig, Forenede Stater
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Larissa University HospitalRekrutteringDumping syndrom | MavekirurgiGrækenland
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University Hospital, LilleAfsluttet
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Universitaire Ziekenhuizen KU LeuvenAfsluttetPostoperativt dumpingsyndromBelgien
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Cambridge University Hospitals NHS Foundation TrustAfsluttet
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University Hospital Inselspital, BerneAfsluttetDumping syndrom | Hypoglykæmi, ReaktivSchweiz