Surveillance Endoscopy After Proximal Gastriectomy With Double Tract Reconstruction.

NCT ID: NCT06477562

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2024-06-01

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.

Conditions

Gastric Cancer; Proximal Gastric Adenocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Proximal gastrectomy with double tract reconstruction group

Endoscopy

Intervention Type: OTHER

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

Interventions

Endoscopy

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint Vincent's Hospital, Korea

OTHER

Sponsor Role: lead

Responsible Party

Ki Bum Park

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jiwon Seo

Suwon, Gyeong-Gi-Do, South Korea

Countries

South Korea

Other Identifiers

VC24WADI0021

Identifier Type: -

Identifier Source: org_study_id