Surveillance Endoscopy After Proximal Gastriectomy With Double Tract Reconstruction.

Completed

• Conditions: Proximal Gastric Adenocarcinoma; Gastric Cancer

• Registration Number: NCT06477562
• Lead Sponsor: Saint Vincent's Hospital, Korea

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-15
• Primary Completion: 2024-03-02
• Status Verified: 2024-06
• Study Completion: 2024-06-01
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Last Update Submitted: 2024-06-21
• Study First Posted: 2024-06-27
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful surveillance endoscopy	Routine endoscopic surveillance was performed 6 months after surgery.	Obtaining an endoscopic image of the pyloric antrum.

Trial Locations

Locations (1)

Jiwon Seo; 🇰🇷 Suwon, Gyeong-Gi-Do, Korea, Republic of