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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Seongyong Park, Ph.D
- 電話番号：+82-10-5388-5715
- メール：syparkcs@gmail.com
研究場所
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Gangnam-gu Irwon-Ro 81
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Seoul、Gangnam-gu Irwon-Ro 81、韓国、06351
- 募集
- Samsung Medical Center
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic Agreement Between CGM and OGTT for Dumping Syndrome
時間枠：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.
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Up to 10 days after enrollment, during concurrent OGTT and CGM measurement
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Diagnostic Accuracy of CGM Using Specific Glucose Cut-off Values
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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