- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03978481
Effect of Helicobacter Pylori Eradication After Subtotal Gastrectomy on Survival Rate of Gastric Cancer Patients: Retrospective Study
April 12, 2023 updated by: Nayoung Kim, Seoul National University Bundang Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
3700
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nayoung Kim, M.D., Ph. D.
- Phone Number: 82-31-787-7008
- Email: nayoung49@empas.com
Study Locations
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with gastric cancer and received surgery (partial, distal, subtotal gastrectomy), and tested Helicobacter pylori status in Seoul National University Bundang Hospital, from 2003 to 2018
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Eradicated group
Gastric cancer patients received subtotal gastrectomy, with Helicobacter pylori eradication
|
Antibiotic eradication therapy (triple or quadriple regimen)
|
Negative group
Gastric cancer patients received subtotal gastrectomy, without Helicobacter pylori eradication or Helicobacter pylori negative
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
From date of initial curative surgery for gastric cancer, until the date of death from any cause, up to 60 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
Up to 60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2019
Primary Completion (Actual)
January 30, 2020
Study Completion (Actual)
April 30, 2020
Study Registration Dates
First Submitted
June 2, 2019
First Submitted That Met QC Criteria
June 6, 2019
First Posted (Actual)
June 7, 2019
Study Record Updates
Last Update Posted (Actual)
April 13, 2023
Last Update Submitted That Met QC Criteria
April 12, 2023
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1902-523-107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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