Identifying factors contributing to poor outcomes in patients with gastric cancer.

ISRCTN	ISRCTN35024819
DOI	https://doi.org/10.1186/ISRCTN35024819

Submission date: 12/03/2019
Registration date: 26/03/2019
Last edited: 24/09/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Study website

Contact information

Dr Hitomi Takechi
Public

1-10-23, Hirahara, Onomichi-shi
Hiroshima
722-8508
Japan

Phone	+81 848 22 8111
Email	red.df2fb@gmail.com

Study information

Study design	Retrospective, single-centre, observational, longitudinal study
Primary study design	Observational
Secondary study design	Longitudinal study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
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
Study acronym	GC, PNI
Study objectives	We aimed to evaluate the factors that contribute to the poor prognoses of gastric cancer patients.
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	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
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 study start date	09/05/2011
Completion date	30/06/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	182 patients
Total final enrolment	182
Key inclusion criteria	Post-curative resection gastric cancer patients
Key exclusion criteria	N/A
Date of first enrolment	14/12/2016
Date of final enrolment	15/05/2017

Locations

Countries of recruitment

Japan

Study participating centre

Department of Surgery, Onomichi General Hospital

1-10-23, Hirahara, Onomichi-shi
Hiroshima
722-8508
Japan

Sponsor information

Department of Surgery, Onomichi General Hospital
Hospital/treatment centre

1-10-23, Hirahara, Onomichi-shi
Hiroshima
722-8508
Japan

Phone	0848228111
Email	red.df2fb@gmail.com
Website	http://onomichi-gh.jp/
"ROR"	https://ror.org/05nr3de46

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	31/03/2019
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in BMC Gastroenterology.
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		05/08/2020	24/09/2021	Yes	No

Editorial Notes

24/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
29/03/2019: Internal review.
22/03/2019: Trial's existence confirmed by the Ethical Review Board of Onomichi General Hospital.