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OpenTrials
Completed

NCT Number: NCT03978481

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Helicobacter pylori eradication (combination therapy)

Combination Product

Antibiotic eradication therapy (triple or quadriple regimen)

Primary outcomes

  1. Overall survival

    Time frame: From date of initial curative surgery for gastric cancer, until the date of death from any cause, up to 60 months

Secondary outcomes

  1. Gastric cancer-specific (disease-free) survival

    Time frame: 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

  2. Metachronous cancer (remnant stomach cancer)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 7, 2019
Registry last updated
Nov 29, 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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