Plain English Summary
Background and study aims
Gastric cancer (GC) is the second leading cause of cancer-related mortality worldwide. Therefore, identifying the predictive factors for surgical morbidity, disease recurrence, and long-term survival is necessary for preventing GC patient mortality. We aimed to evaluate the factors that contribute to the poor prognoses of GC patients.
Who can participate?
All post-curative resection gastric cancer patients.
What does the study involve?
All patients underwent total or distal gastrectomy, and we gave chemotherapy to the patient whom a state has good.
What are the possible benefits and risks of participating?
No benefits and risks of participating.
Where is the study run from?
Onomichi General Hospital
When is the study starting and how long is it expected to run for?
May 2011 to June 2017.
Who is funding the study?
Investigator-initiated and funded.
Who is the main contact?
Hitomi Takechi, red.df2fb@gmail.com
Trial website
Contact information
Type
Public
Primary contact
Dr Hitomi Takechi
ORCID ID
Contact details
1-10-23
Hirahara
Onomichi-shi
Hiroshima
722-8508
Japan
+81 848 22 8111
red.df2fb@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
N/A
Study information
Scientific title
Using the preoperative prognostic nutritional index as a predictive factor for non-cancer-related death in post-curative resection gastric cancer patients: a retrospective study
Acronym
GC, PNI
Study hypothesis
We aimed to evaluate the factors that contribute to the poor prognoses of gastric cancer patients.
Ethics approval
Approved 14/03/2019, Ethical Review Board of Onomichi General Hospital (1-10-23, Hirahara, Onomichi-shi, Hiroshima, 722-8508, Japan; +81-848-22-8111), ref: OJH-201892.
Study design
Retrospective, single-centre, observational, longitudinal study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Gastric adenocarcinomas
Intervention
All patients underwent total or distal gastrectomy and D1+ or D2 lymph node dissection in accordance with the Japanese Gastric Cancer Treatment Guidelines published in 2010 (ver. 3). All patients were histologically confirmed to have stage I, II, or III gastric adenocarcinomas and underwent total or distal gastrectomy. The total duration of observation and follow-up were conducted within 5 years post-operation, or until death.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Disease-free survival is defined as the time between the date of surgery and disease recurrence or the last available follow-up.
2. Overall survival is defined as the time between the date of surgery and death or the last available follow-up.
Secondary outcome measures
1. Absolute neutrophil and lymphocyte counts are measured using routine blood and biochemical tests on the day before surgery.
2. Serum albumin is measured using routine blood and biochemical tests on the day before surgery.
3. C-reactive protein (CRP) concentrations are measured using routine blood and biochemical tests on the day before surgery.
4. Prognosis is measured using the modified Glasgow Prognosis Score, perineural invasion and neutrophil to lymphocyte ratio on the day before surgery.
5. Diagnosis is determined using surgical pathology reports after surgery.
Overall trial start date
09/05/2011
Overall trial end date
30/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Post-curative resection gastric cancer patients
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
182 patients
Participant exclusion criteria
N/A
Recruitment start date
14/12/2016
Recruitment end date
15/05/2017
Locations
Countries of recruitment
Japan
Trial participating centre
Department of Surgery, Onomichi General Hospital
1-10-23, Hirahara, Onomichi-shi
Hiroshima
722-8508
Japan
Sponsor information
Organisation
Department of Surgery, Onomichi General Hospital
Sponsor details
1-10-23
Hirahara
Onomichi-shi
Hiroshima
722-8508
Japan
0848228111
red.df2fb@gmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in BMC Gastroenterology.
IPD sharing statement: the datasets generated during and/or analysed during the current study are/will be available upon request from Hitomi Takechi (red.df2fb@gmail.com). The data will be available for 5 years.
Intention to publish date
31/03/2019
Participant level data
Available on request
Basic results (scientific)
Publication list