- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06477562
Surveillance Endoscopy After Proximal Gastriectomy With Double Tract Reconstruction.
June 21, 2024 updated by: Ki Bum Park, Saint Vincent's Hospital, Korea
The Success Rate and Associated Factors for Surveillance Endoscopy After Proximal Gastrectomy With Double Tract Reconstruction: Multicenter Retrospective Study
The primary purpose of surveillance endoscopy after gastric cancer surgery is to detect malignancy recurrence in the remnant stomach.
This study aims to analyze the rate of proper remnant stomach observation following proximal gastrectomy(PG) with double tract reconstruction (DTR).
Data from patients who underwent PG with DTR for gastric cancer at six institutions in South Korea from 2011 to 2023 were included.
Clinicopathological and serial endoscopic data were retrospectively reviewed and analyzed.
Successful surveillance endoscopy was defined as obtaining an endoscopic image of the pyloric antrum.
Factors associated with successful endoscopy were analyzed using a mixed-effects logistic regression model.
A total of 634 surveillance endoscopies were performed on 160 patients after PG with DTR.
The median duration from surgery to the endoscopy was 17.5 months (range, 0-137 months).
The success rate of the endoscopies was 75.6%, with a mean time of 271.7±300.5 seconds to reach the pyloric antrum.
The average total procedure time for successful endoscopic examinations was 439.4±336.0
seconds, compared to 373.7±326.0
seconds for failed examinations.
(p=0.033).
Among patients who underwent the procedure twice or more, 6.5% had all endoscopic examinations fail, while 2.8% of those who underwent the procedure three times or more experienced failure in all examinations.
Factors associated with successful endoscopy included longer procedure time (OR 1.32, 95% CI 1.01-1.72),
endoscopy performed by a non-surgeon (OR 0.19, 95% CI 0.11-0.36),
longer duration after surgery (OR 1.33, 95% CI 1.02-1.72)
and younger age (OR 0.70, 95% CI 0.49-0.97).
Understanding the anatomic alterations after PG with DTR is crucial for the success of surveillance endoscopy.
Additionally, the duration from surgery to endoscopy is associated with the success of the examination, and the rate of failure across all serial endoscopies is very low.
Therefore, clinicians should perform endoscopies with sufficient procedure time and conduct endoscopies regardless of the failure of previous examinations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeong-Gi-Do
-
Suwon, Gyeong-Gi-Do, Korea, Republic of, 16247
- Jiwon Seo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who underwent proximal gastrectomy with double tract reconstruction and had at least one postoperative surveillance endoscopy.
Description
Inclusion Criteria:
Patients who underwent proximal gastrectomy with double tract reconstruction and had at least one postoperative surveillance endoscopy.
Exclusion Criteria:
Patients who did not undergo postoperative surveillance endoscopy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Proximal gastrectomy with double tract reconstruction group
|
surveillance endoscopy was routinely performed to the patients with proximal gastrectomy with double tract reconstruction group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Successful surveillance endoscopy
Time Frame: Routine endoscopic surveillance was performed 6 months after surgery.
|
Obtaining an endoscopic image of the pyloric antrum.
|
Routine endoscopic surveillance was performed 6 months after surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2024
Primary Completion (Actual)
March 2, 2024
Study Completion (Actual)
June 1, 2024
Study Registration Dates
First Submitted
June 21, 2024
First Submitted That Met QC Criteria
June 21, 2024
First Posted (Actual)
June 27, 2024
Study Record Updates
Last Update Posted (Actual)
June 27, 2024
Last Update Submitted That Met QC Criteria
June 21, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VC24WADI0021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.