Surveillance Endoscopy After Proximal Gastriectomy With Double Tract Reconstruction.

NCT06477562 | Completed

• 1 other identifier: VC24WADI0021
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Successful surveillance endoscopy

  Obtaining an endoscopic image of the pyloric antrum.

  Routine endoscopic surveillance was performed 6 months after surgery.

Study Arms (1)

Proximal gastrectomy with double tract reconstruction group

Other: Endoscopy

Interventions

Endoscopy OTHER

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

Proximal gastrectomy with double tract reconstruction group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent proximal gastrectomy with double tract reconstruction and had at least one postoperative surveillance endoscopy.

You may qualify if:

• Patients who underwent proximal gastrectomy with double tract reconstruction and had at least one postoperative surveillance endoscopy.

You may not qualify if:

• Patients who did not undergo postoperative surveillance endoscopy.

Sponsors & Collaborators

• Saint Vincent's Hospital, Korea: lead

Study Sites (1)

Jiwon Seo

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

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: February 15, 2024
• Primary Completion: March 2, 2024
• Study Completion: June 1, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)