UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014284
Receipt No. R000016634
Scientific Title Establishment of Surgical Audit System for Overall Survival following Gastric Cancer Resection
Date of disclosure of the study information 2014/06/30
Last modified on 2018/06/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
Condition Patients who underwent gastric cancer resection
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
Primary outcomes Postoperative overall survival
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute National Hospital Organization Kumamoto Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
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.

Management information
Registered date
2014 Year 06 Month 17 Day
Last modified on
2018 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016634

Research Plan
Registered date File name
2018/06/19 ESA-GC研究計画書1.3.docx

Research case data specifications
Registered date File name
2018/06/19 ESAGCdata2.xlsx

Research case data
Registered date File name


Contact us.