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.

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Key information

Conditions

Esophagectomy Continous Glucose Measurement Digestive System Diseases Dumping Syndrome Gastrointestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postgastrectomy Syndromes Postoperative Complications Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, Gangnam-gu Irwon-Ro 81, 06351, South Korea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-1. aged 18 or older. 2. people who underwent esophagectomy and gastric tube reconstruction for esophageal cancer.

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.

Treatment and study plan

Primary outcomes

Diagnostic Agreement Between CGM and OGTT for Dumping Syndrome

Time frame: 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 outcomes

Diagnostic Accuracy of CGM Using Specific Glucose Cut-off Values

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Seongyong Park, Ph.D

CONTACT

[email protected]

+82-10-5388-5715

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Prospective Observational Study on the Utility of Continuous Glucose Monitoring for the Diagnosis of Dumping Syndrome After Esophagectomy

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: May 26, 2026
Registry last updated: May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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