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.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Seongyong Park, Ph.D
- 전화번호: +82-10-5388-5715
- 이메일: syparkcs@gmail.com
연구 장소
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Gangnam-gu Irwon-Ro 81
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Seoul, Gangnam-gu Irwon-Ro 81, 대한민국, 06351
- 모병
- Samsung Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Diagnostic Agreement Between CGM and OGTT for Dumping Syndrome
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Diagnostic Accuracy of CGM Using Specific Glucose Cut-off Values
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SMC-2025-06-033
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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