UMIN-CTR Clinical Trial

Public title

Establishment of quality of care among hospitals in digestive surgery

Acronym

E-PASS study

Scientific Title

Establishment of quality of care among hospitals in digestive surgery

Scientific Title:Acronym

E-PASS study

Region

Japan

Condition

Patients who underwent elective digestive surgery

Classification by specialty

Gastrointestinal surgery

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

1) To establish a method for quality of care in digestive surgery on short-term outcome using the E-PASS scoring system which we generated;
2) To generate a new scoring system to evaluate a quality of care on long term survival rates following surgery for digestive cancer.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

90-day mortality rate

Key secondary outcomes

2 year and 5 year overall survival rates

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 elective digfestive surgery in operating room.

Key exclusion criteria

1) Patients who refused to join this study
2) Patients who have concomitant malignant tumors of multiple organs
3) Patients who had malignant tumors within past 5 years

Target sample size

5000

Name of lead principal investigator

1st name
Middle name
Last name	Yoshio Haga

Organization

National Hospital Organization Kumamoto Medical Center

Division name

Department of Surgery

Zip code

Address

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

TEL

096-353-6501

Email

yoshio@kumamed.jp

Name of contact person

1st name
Middle name
Last name	Yoshio Haga

Organization

National Hospital Organization Kumamoto Medical Center

Division name

Department of SurgeryDepartment of Surgery

Zip code

Address

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

TEL

096-353-6501

Homepage URL

Email

yoshio@kumamed.jp

Institute

National Hospital Organization Kumamoto Medical Center

Institute

Department

Personal name

Organization

National Hospital Organization

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

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

Date of disclosure of the study information

2008

Year

10

Month

02

Day

URL releasing protocol

http://www.jcrac.ac/poppy.ac_contents/nho/img/summary/epass_gaiyou.html

Publication of results

Published

URL related to results and publications

http://journals.lww.com/annalsofsurgery/pages/articleviewer.aspx?year=2011&issue=01000&article=00030&type=abstract

Number of participants that the trial has enrolled

Results

I. Results for short-term outcomes

In this study, we compared our prediction model E-PASS and its modified form mE-PASS with Western models, American Society of Anesthesiologists (ASA) status-based model and Portsmouth modification of Physiologic and Operative Severity Score for the enUmeration of Mortality and morbidity (P-POSSUM) in elective gastrointestinal surgery. The area under the receiver operative characteristic curve (AUC, 95% CI) values were 0.86 (0.79-0.93) for E-PASS, 0.86 (0.79-0.92) for mE-PASS, 0.81 (0.75-0.88) for P-POSSUM and 0.73 (0.63-0.83) for the ASA status-based model. Subsequently, we quantified the ratio of observed- to-estimated in-hospital mortality rates (OE ratio) as a measure of quality. The OE ratios for mE-PASS among large volume hospitals significantly correlated with those for other existing models.

II. Results for long-term outcome gastric cancer resection

We generated a model to predict overall survival (OS) using Cox hazard regression analysis in gastric cancer resection. This model exhibited a better discrimination power (AUC, 95% CI: 0.89, 0.86-0.91) than that for the UICC stage (0.81, 0.77-0.84). Subsequently, we quantified the OE ratio of 5-year OS rates as a measure of quality. The OE ratios among the participating hospitals revealed no significant variation between 0.74 and 1.1.

III. Results for long-term outcome colorectal cancer resection

We generated a model to predict OS using Cox hazard regression analysis in colorectal cancer resection. This model exhibited a better discrimination power (AUC, 95% CI: 0.87, 0.85-0.90) than that for the UICC stage (0.80, 0.76-0.83). Subsequently, we quantified the OE ratio of 5-year OS rates as a measure of quality. The OE ratios among the participating hospitals revealed no significant variation between 0.90 and 1.1.

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

2004

Year

12

Month

14

Day

Date of IRB

Anticipated trial start date

2005

Year

04

Month

01

Day

Last follow-up date

2012

Year

04

Month

16

Day

Date of closure to data entry

2012

Year

04

Month

16

Day

Date trial data considered complete

2012

Year

04

Month

30

Day

Date analysis concluded

Other related information

This study was supported by the grant of National Hospital Organization Multi-Center Clinical Research for Evidence-Based Medicine.

I. The above study results regarding short-term outcome were published in Annals of Surgery.

Haga Y, Ikejiri K, Wada Y, Takahashi T, Ikenaga M, Akiyama N, Koike S, Koseki M, Saitoh T: A multicenter prospective study of surgical audit systems. Ann Surg 2011; 253(1): 194-201.

II. The results for long-term outcome in gastric cancer resection were published in Gastric Cancer.

Haga Y, Wada Y, Takeuchi H, Ikejiri K, Ikenaga M, Kimura O: Evaluation of modified Estimation of Physiologic Ability and Surgical Stress (mE-PASS) in gastric carcinoma surgery. Gastric Cancer. 2012;15(1): 7-14.

III. The results for long-term outcome in colorectal cancer resection were published in World Journal of Surgery.

Haga Y, Ikejiri K, Wada Y, Ikenaga M, Koike S, Nakamura S, Koseki M. The EPOS-CC score: an integration of independent, tumor- and patient-associated risk factors to predict 5-year overall survival following colorectal cancer surgery. Wolrd J Surg, published online at http://link.springer.com/article/10.1007/s00268-015-2962-3.

Registered date

2008

Year

10

Month

02

Day

Last modified on

2015

Year

04

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001713