UMIN-CTR Clinical Trial

Public title

Establishment of Surgical Audit System for Overall Survival following Gastric Cancer Resection

Acronym

ESAGC study

Scientific Title

Establishment of Surgical Audit System for Overall Survival following Gastric Cancer Resection

Scientific Title:Acronym

ESAGC study

Region

Japan

Condition

Patients who underwent gastric cancer resection

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This study was undertaken to evaluate whether or not we could predict postoperative 5-year overall survival following gastric cancer resections, using a minimal set of physiologic and tumor-related variables. We also aim to examine the feasibility of surgical audit using this prediction method.

Basic objectives2

Others

Basic objectives -Others

Outcome research

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Postoperative overall survival

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent gastric cancer resection between April 2007 and March 2009 in 11 referral hospitals in Japan.

Key exclusion criteria

1) those who underwent emergency operations, 2) those who had received preoperative chemotherapy, 3) those who had non-epithelial tumors in stomach, such as malignant lymphoma, carcinoid, or gastrointestinal stromal tumor, 4) those who had a past history of treating other malignancies, 5) those who had other malignancies than gastric cancer at the time of operation.

Target sample size

2000

Name of lead principal investigator

1st name
Middle name
Last name	Yoshio Haga

Organization

National Hospital Organization Kumamoto Medical Center

Division name

Institute for Clinical Research

Zip code

Address

1-5 Ninomaru, Chuo-ku, Kumamoto 8600008, Japan

TEL

096-366-0590

Email

yoshio@kumamed.jp

Name of contact person

1st name
Middle name
Last name	Katsuya Yamashita

Organization

National Hospital Organization Kumamoto Medical Center

Division name

Center for Clinical trials

Zip code

Address

1-5 Ninomaru, Chuo-ku, Kumamoto 8600008, Japan

TEL

096-366-0590

Homepage URL

http://www.nho-kumamoto.jp/medical/clinical-research/cr-observational/esagc.html

Email

yamakatu@kumamoto2.hosp.go.jp

Institute

National Hospital Organization Kumamoto Medical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

熊本赤十字病院、済生会熊本病院、熊本地域医療センター、国立病院機構四国がんセンター、大阪労災病院、国立病院機構九州がんセンター、国立病院機構大阪医療センター、国立病院機構九州医療センター、国立病院機構岩国医療センター、国立病院機構熊本医療センター、横浜市立大学附属市民総合医療センター

Date of disclosure of the study information

2014

Year

06

Month

30

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.ejso.com/article/S0748-7983(18)30010-6/fulltext

Number of participants that the trial has enrolled

Results

We included 2045 patients for analysis. The median (95% confidence interval) follow-up time was 5.1 (1.2-6.8) years for censored patients. Although EPOS-GC demonstrated a good discriminative power (Harrell's C-index, 95% confidence interval: 0.80, 0.79-0.83), the calibration plot revealed that EPOS-GC underestimated 5-year survival rates in the high-risk group. Therefore, we recalibrated the model with Cox's regression analysis. The recalibrated EPOS-GC showed a good calibration, preserving the high discriminative power (C-index, 95% confidence interval: 0.80, 0.78-0.82). The O/E among hospitals according to the recalibrated EPOS-GC ranged between 0.87 and 1.27. The O/E correlated with hospital volumes (Spearman's correlation = 0.76, n = 11, p = .006).

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2014

Year

06

Month

17

Day

Date of IRB

Anticipated trial start date

2014

Year

07

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

2015

Year

10

Month

31

Day

Date analysis concluded

2017

Year

10

Month

16

Day

Other related information

1. Study design is a multicenter, retrospective cohort study.

2. Data to be collected
1) Preoperative variables
(1) Basic information: age, gender, hight, weight
(2) Physiologic factors: severe pulmonary disease (%VC < 60% or FEV1.0% <50%), respiratory signs (short breath on exertion, short breath at rest), performance status, ASA class, hemoglobin level, serum albumin level, serum sodium level
2) Operative variables
surgical procedure, level of nodal dissection
3) Pathological variables
depth of invasion, number of metastatic lymph nodes, number of dissected lymph nodes, distant metastasis, gross appearance, occupied portions, circulation, histological type, lymphatic invasion, venous invasion, residual disease
3. Statistical analysis of main outcome measure
1) Univariate analysis: Effect of each variable on overall survival will be evaluated using log-rank test.
2) Multivariate analysis: Using the significant variables by the univariate analysis, a prediction model will be constructed for postoperative overall survival.
3) Testing discrimination power: Discrimination power of the newly constructed model and our prediction model, EPOS-GC, in the precedent study [1] will be tested using ROC curve analysis or c-index.
4) Testing calibration power: The calibration power of the newly-constructed model and EPOS-GC will be tested using Hosmer-Lemeshow test.
5) Comparative audit between centers: Ratios of Observed-to-Expected 5 year overall survival rates (OE ratio) will be calculated in the participating hospitals, using EPOS-GC or the newly-constructed model. We will test whether there is a significant difference of the OE ratios between the hospitals, using chi-square test.

3. Reference
[1] Haga Y, Ikejiri K, Wada Y, Ikenaga M, Takeuchi H. Preliminary study of surgical audit for overall survival following gastric cancer resection. Gastric Cancer, published online at http://link.springer.com/article/10.1007/s10120-014-0343-5.

Registered date

2014

Year

06

Month

17

Day

Last modified on

2018

Year

06

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016634