EsophagectomyNCT07605481
Dumping Syndrome After Esophagectomy
An observational study of Esophagectomy and Dumping Syndrome, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagectomy, Dumping Syndrome, Continous Glucose Measurement
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jun 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients registered at Samsung Medical Center
Who may be able to join
- -1. aged 18 or older. 2. people who underwent esophagectomy and gastric tube reconstruction for esophageal cancer.
- 3. Sigstad score of 7 or higher.
Who cannot join
- 1. Diabetes with autonomic neuropathy. 2. Inability to complete the diagnostic procedure (e.g., cognitive decline). 3. Refusal to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnam-gu Irwon-Ro 81, 06351
About this study
Official title: 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.
Read more
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.
- Keywords
- esophagectomy, dumping syndrome
- Medical subject headings
- Dumping Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Up to 10 days after enrollment, during concurrent OGTT and CGM measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagectomyStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong Yong Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605481
- Sponsor's protocol ID
- SMC-2025-06-033
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on the Utility of Continuous Glucose Monitoring for the Diagnosis of Dumping Syndrome After Esophagectomy
- ClinicalTrials.gov ID
- NCT07605481
- Acronym / sponsor ID
- SMC-2025-06-033
- Keywords
- esophagectomy, dumping syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients registered at Samsung Medical Center
Key inclusion criteria (2 listed)
- -1. aged 18 or older. 2. people who underwent esophagectomy and gastric tube reconstruction for esophageal cancer.
- 3. Sigstad score of 7 or higher.
Key exclusion criteria (1 listed)
- 1. Diabetes with autonomic neuropathy. 2. Inability to complete the diagnostic procedure (e.g., cognitive decline). 3. Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Diagnostic Accuracy of CGM Using Specific Glucose Cut-off Values
Time frame: Up to 10 days after enrollment, during concurrent OGTT and CGM measurement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
Related trials for Esophagectomy
RecruitingPhase 3
Modular Robot-Assisted Versus Conventional Minimally Invasive Esophagectomy for Esophageal Cancer
Esophageal Cancer
Active, not recruitingObservational study
Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
Esophageal Cancer, Esophagus Cancer
RecruitingPhase 2
OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy
Anastomotic Leak Esophagus
RecruitingObservational study
Evaluation of Seismocardiography(SCG) for Assessing Fitness and Predicting Outcomes in Oesophageal Cancer Surgery
Oesophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
PAravertebral CaTheter Versus Epidural Analgesia in Totally Minimally Invasive Esophagectomies
Esophageal Cancer, Esophagectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagectomy and Dumping Syndrome, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seongyong Park, Ph.D (+82-10-5388-5715, syparkcs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Agreement Between CGM and OGTT for Dumping Syndrome (time frame: Up to 10 days after enrollment, during concurrent OGTT and CGM measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.