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OpenTrials
Completed

NCT Number: NCT06477562

Surveillance Endoscopy After Proximal Gastriectomy With Double Tract Reconstruction.

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jiwon Seo

Suwon, Gyeong-Gi-Do, 16247, South Korea

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Endoscopy

Other

surveillance endoscopy was routinely performed to the patients with proximal gastrectomy with double tract reconstruction group.

Primary outcomes

  1. Successful surveillance endoscopy

    Time frame: Routine endoscopic surveillance was performed 6 months after surgery.

    Obtaining an endoscopic image of the pyloric antrum.

Sponsors and collaborators

Lead sponsor

Saint Vincent's Hospital, Korea

Other

Registry information

Official study title

The Success Rate and Associated Factors for Surveillance Endoscopy After Proximal Gastrectomy With Double Tract Reconstruction: Multicenter Retrospective Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 27, 2024
Registry last updated
Jun 27, 2024

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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