UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020070 |
|---|---|
| Receipt number | R000022904 |
| Scientific Title | Postoperative quality of life after gastrectomy for Stage I gastric cancer; a comparison analysis between total gastrectomy and proximal gastrectomy |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2022/06/09 09:18:11 |
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Basic information
Public title
Postoperative quality of life after gastrectomy for Stage I gastric cancer; a comparison analysis between total gastrectomy and proximal gastrectomy
Acronym
Postoperative quality of life after gastrectomy for Stage I gastric cancer; a comparison analysis between total gastrectomy and proximal gastrectomy
Scientific Title
Postoperative quality of life after gastrectomy for Stage I gastric cancer; a comparison analysis between total gastrectomy and proximal gastrectomy
Scientific Title:Acronym
Postoperative quality of life after gastrectomy for Stage I gastric cancer; a comparison analysis between total gastrectomy and proximal gastrectomy
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare postoperative quality of life between total gastrectomy and proximal gastrectomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare postoperative body weight loss between total gastrectomy and proximal gastrectomy.
Key secondary outcomes
Scores of questionnaires;QLQ-C30, STO22 and PGSAS37, body composition, blood test, disease-free survival, overall survival and prevalence of remnant gastric cancer.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Total gastrectomy
Questionnaire
Perioperative
Interventions/Control_2
Proximal gastrectomy
Questionnaire
Perioperative
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) pathologically-confirmed gastric cancer (papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma, signet ring cell carcinoma and mucinous adenocarcinoma)
2) cStage IA or IB, but not T2 tumor at the greater curvature of the stomach
3) No indication of endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) in a cN0 or cN1case
4) Patients who underwent EMR or ESD and need additional surgery
5) No invasion of the esophagus
6) Aged 20 to 80 year
7) PS (ECOG) 0 or 1
8) No history of gastrointestinal surgery
9) No history of chemotherapy or radiotherapy
10) Capability of filling out a survey independently
11) Provided written informed consent
Key exclusion criteria
1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ
2) Simultaneous surgery other than cholecystectomy
3) Body mass index 30 or more
4) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kodera |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2111
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuro |
| Middle name | |
| Last name | Kanda |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2111
Homepage URL
m-kanda@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Ethics Review Committee
Address
65 Tsurumai-cho,Showa-ku,Nagoya
Tel
052-744-2479
ethics@med.nagoya-u.ac.jp
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
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
110
Results
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study of postoperative quality of life after gastrectomy for Stage I gastric cancer, a comparison analysis between total gastrectomy and proximal gastrectomy using a questionnaire
Management information
Registered date
| 2015 | Year | 12 | Month | 04 | Day |
Last modified on
| 2022 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022904
