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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020070
Receipt No. 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 2019/06/07

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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
Email 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
Email m-kanda@med.nagoya-u.ac.jp

Sponsor
Institute Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2020 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
2019 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022904

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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