Dumping Syndrome After Esophagectomy

NCT07605481 | Recruiting DMC

• 1 other identifier: SMC-2025-06-033
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagectomy; Dumping Syndrome; Continous Glucose Measurement

Keywords

esophagectomy; dumping syndrome

Outcome Measures

Primary Outcomes (1)

• Diagnostic Agreement Between CGM and OGTT for Dumping Syndrome

  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.

  Up to 10 days after enrollment, during concurrent OGTT and CGM measurement

Secondary Outcomes (1)

• Diagnostic Accuracy of CGM Using Specific Glucose Cut-off Values

  Up to 10 days after enrollment, during concurrent OGTT and CGM measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients registered at Samsung Medical Center

You may qualify if:

• aged 18 or older. 2. people who underwent esophagectomy and gastric tube reconstruction for esophageal cancer.
• \. Sigstad score of 7 or higher.

You may not qualify if:

• \. Diabetes with autonomic neuropathy. 2. Inability to complete the diagnostic procedure (e.g., cognitive decline). 3. Refusal to participate.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

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

RECRUITING

MeSH Terms

Conditions

Dumping Syndrome

Condition Hierarchy (Ancestors)

Postgastrectomy Syndromes; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Seongyong Park, Ph.D

CONTACT

+82-10-5388-5715; syparkcs@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, Ph.D, Department of Thoracic and Cardiovascular Surgery

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 26, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

KR (1)