UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029732 |
|---|---|
| Receipt number | R000033633 |
| Scientific Title | Epidemic Research of Treatment for Gastric Outlet Stenosis due to Gastric Cancer in Japan |
| Date of disclosure of the study information | 2017/10/29 |
| Last modified on | 2020/01/31 16:30:18 |
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Basic information
Public title
Epidemic Research of Treatment for Gastric Outlet Stenosis due to Gastric Cancer in Japan
Acronym
ERGO-J study
Scientific Title
Epidemic Research of Treatment for Gastric Outlet Stenosis due to Gastric Cancer in Japan
Scientific Title:Acronym
ERGO-J study
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the actual status of treatment options for gastric outlet stenosis due to gastric cancer in Japan and to analyze their efficacy, safety and prognostic factors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative time for which at least liquid can be taken.
Key secondary outcomes
1. short-term outcome
Clinical success of treatment
Postoperative complications
In-hospital death
Postoperative length of stay
Technical success of stent insertion
Removal of stent
2. Long-term outcome
Overall survival
Induction of chemotherapy
Transition to resection
Obstruction of stent
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 endoscopic stenting or gastroenterostomy for stenosis of gastric pylorus or duodenum due to gastric cancer between January 2015 and December 2015.
Key exclusion criteria
Non-epithelial tumors
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Yoshida |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Surgical Oncology Oncology
Zip code
5011194
Address
1-1 Yanagido, Gifu, 501-1194 Japan
TEL
81-58-230-6235
kyoshida@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Haga |
Organization
Japan Community Healthcare Organization Amakusa Central General Hospital
Division name
Surgery
Zip code
8630033
Address
101 Higashi-machi, Amakusa-shi, Kumamoto-ken 863-0033, Japan
TEL
81-969-22-0011
Homepage URL
epass2006@outlook.com
Sponsor or person
Institute
Japan Gastric Cancer Association
Institute
Department
Personal name
Funding Source
Organization
Japan Gastric Cancer Association
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
Japan Community Healthcare Organization Amakusa Central General Hospital
Address
101 Higashi-machi, Amakusa-shi, Kumamoto-ken 863-0033, Japan
Tel
81-969-22-0011
epass2006@outlook.com
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033633
Publication of results
Published
Result
URL related to results and publications
http://link.springer.com/article/10.1007/s10120-020-01040-0
Number of participants that the trial has enrolled
179
Results
Baseline data revealed that stent patients had lower food intake, poorer performance status, and worse prognostic indices than gastrojejunostomy patients. After propensity score matching, the frequency of postoperative complications was significantly less in stent patients than in gastrojejunostomy patients. A low residue or full diet was achieved by 97% of stent patients and 97% of gastrojejunostomy patients. Median survival times were not significantly different between the two groups.
Results date posted
| 2020 | Year | 01 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Baseline data revealed that stent patients had lower food intake, poorer performance status, and worse prognostic indices of GPS, PNI and PRS than gastrojejunostomy patients.
Participant flow
The secretariat of the JGCA sent invitation letters to 326 delegates at 212 hospitals. Seventy-seven hospitals declared their participation, and data were ultimately provided by 42. We obtained data on 85 patients who underwent stent therapy and 94 who underwent gastrojejunostomy.
Adverse events
After propensity score matching, the frequency of postoperative complications was significantly less in stent patients (3%, 1/33) than in gastrojejunostomy patients (21%, 7/34; p=0.03).
Outcome measures
After propensity score matching, a low residue or full diet was achieved by 97% of stent patients (32/33) and 97% of gastrojejunostomy patients (33/34) (p=0.98). Median survival times were 7.8 months in stent patients and 4.0 months in gastrojejunostomy patients (p=0.38).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Variables to be collected
1-1. Preoperative variables
1) Demographic data: age, gender, height, weight
2) Preoperative tumor evaluation: depth of invasion, lymph node metastasis, distant metastasis (organs), macroscopic type, location of the tumor
3) Preoperative physical status: Duration of impaired food intake, Food intake (Gastric Outlet Obstruction Score: GOOS), Performance status, biliary stenting, serum C-reactive protein level, serum albumin level, serum sodium level, lymphocyte count, neutrophil count, hemoglobin level, tumor marker levels (CEA, CA19-9), severe heart disease, severe pulmonary disease, diabetes mellitus, American Society Association physical status for patients undergoing gastroenterostomy
1-2. Operative variables
Surgical procedures.
For stenting, maker, product, covering.
For gastroenterostomy, blood loss during operation, operation time, surgical approach (laparotomy or laparoscopic), anastomosis method (hand-sewn or stapling), anastomotic site, Braun anastomosis, partitioning
Management information
Registered date
| 2017 | Year | 10 | Month | 26 | Day |
Last modified on
| 2020 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033633
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/01/24 | ERGO-J1.5.1.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/01/24 | datafile1.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/01/24 | datafile2.xlsx |
