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出境医 / 临床实验 / Effect of Helicobacter Pylori Eradication After Subtotal Gastrectomy on Survival Rate of Gastric Cancer Patients: Retrospective Study

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

Study Description
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.

Condition or disease Intervention/treatment
Gastric Cancer Combination Product: Helicobacter pylori eradication (combination therapy)

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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 3800 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effect of Helicobacter Pylori Eradication After Subtotal Gastrectomy on Survival Rate of Gastric Cancer Patients: Retrospective Study
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : January 30, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Eradicated group
Gastric cancer patients received subtotal gastrectomy, with Helicobacter pylori eradication
 Combination Product: Helicobacter pylori eradication (combination therapy)
Antibiotic eradication therapy (triple or quadriple regimen)
Negative group
Gastric cancer patients received subtotal gastrectomy, without Helicobacter pylori eradication or Helicobacter pylori negative
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations

Contacts
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Contact: Nayoung Kim, M.D., Ph. D. 82-31-787-7008 nayoung49@empas.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Nayoung Kim    82317877009    nayoungkim49@empas.com   
Contact: Sohn    821052164932      
Principal Investigator: Nayoung Kim, M.D.,Ph.D.         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Tracking Information
First Submitted Date June 2, 2019
First Posted Date June 7, 2019
Last Update Posted Date March 23, 2021
Actual Study Start Date January 30, 2019
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2019) 		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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 6, 2019)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Helicobacter Pylori Eradication After Subtotal Gastrectomy on Survival Rate of Gastric Cancer Patients: Retrospective Study
Official Title Effect of Helicobacter Pylori Eradication After Subtotal Gastrectomy on Survival Rate of Gastric Cancer Patients: Retrospective Study
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Gastric Cancer
Intervention Combination Product: Helicobacter pylori eradication (combination therapy)
Antibiotic eradication therapy (triple or quadriple regimen)
Study Groups/Cohorts
  • Eradicated group
    Gastric cancer patients received subtotal gastrectomy, with Helicobacter pylori eradication
    Intervention: Combination Product: Helicobacter pylori eradication (combination therapy)
  • Negative group
    Gastric cancer patients received subtotal gastrectomy, without Helicobacter pylori eradication or Helicobacter pylori negative
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 6, 2019) 		3800
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 30, 2022
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Nayoung Kim, M.D., Ph. D. 82-31-787-7008 nayoung49@empas.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03978481
Other Study ID Numbers B-1902-523-107
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Nayoung Kim, Seoul National University Bundang Hospital
Study Sponsor Seoul National University Bundang Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Seoul National University Bundang Hospital
Verification Date March 2021

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