Effect of Helicobacter Pylori Eradication After Subtotal Gastrectomy on Survival Rate of Gastric Cancer Patients: Retrospective Study

Completed

• Conditions: Gastric Cancer
• Interventions: Combination Product: Helicobacter pylori eradication (combination therapy)

• Registration Number: NCT03978481
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

In this study, we will observe the long-term survival rate, overall mortality rate, gastric cancer specific mortality rate, and the incidence rate of metachronous cancer in patients who received subtotal gastrectomy, with or without Helicobacter pylori eradication.

Detailed Description

In this study, we will observe the long-term survival rate, overall mortality rate, gastric cancer specific mortality rate, and the incidence rate of metachronous cancer in patients who received subtotal gastrectomy, with or without Helicobacter pylori eradication. In addition, we will analyze the correlation between the incidence and survival rate of this type of stomach cancer by comparing smoking, gastric cancer direct family history, disease stage (TNM staging), the histologic type of stomach cancer (intestinal, diffuse, mixed), and the surgical method (Billoth I, Billoth II) as well as the infection and eradication status of H. pylori.

Study Timeline

• Study Start: 2019-01-30
• Study First Submitted: 2019-06-02
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Primary Completion: 2020-01-30
• Study Completion: 2020-04-30
• Status Verified: 2021-03
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3700

Inclusion Criteria

• Patients diagnosed with gastric cancer and received surgery (partial, distal, subtotal gastrectomy), and tested Helicobacter pylori status

Exclusion Criteria

• Patients with other severe diseases (other primary cancer, severe cardiovascular, cerebral, renal, hepatic diseases)
• Patients received palliative treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eradicated group	Helicobacter pylori eradication (combination therapy)	Gastric cancer patients received subtotal gastrectomy, with Helicobacter pylori eradication

Primary Outcome Measures

Name	Time	Method
Overall survival	From date of initial curative surgery for gastric cancer, until the date of death from any cause, up to 60 months

Secondary Outcome Measures

Name	Time	Method
Gastric cancer-specific (disease-free) survival	From date of initial curative surgery for gastric cancer, until the date of diagnosis of gastric cancer recurrence or the date of death, whichever comes first, up to 60 months	Survival period without cancer recurrence or newly developed stomach cancer diagnosis
Metachronous cancer (remnant stomach cancer)	Up to 60 months	The number of patients who were diagnosed with new carcinoma on the remnant stomach, over follow-up period of up to 60 months, in eradication group and non-eradication group

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of