Condition category
Cancer
Date applied
12/03/2019
Date assigned
26/03/2019
Last edited
29/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

N/A

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

http://onomichi-gh.jp/

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

Publication citations

Additional files

Editorial Notes

29/03/2019: Internal review. 22/03/2019: Trial's existence confirmed by the Ethical Review Board of Onomichi General Hospital.