UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032221 |
|---|---|
| Receipt number | R000036743 |
| Scientific Title | A study on the optimal gastrectomy procedures to improve postoperative QOL for the cancer located at the upper third of the stomach or at around the esophagogastric junction |
| Date of disclosure of the study information | 2018/04/17 |
| Last modified on | 2020/10/13 10:33:49 |
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Basic information
Public title
A study on the optimal gastrectomy procedures to improve postoperative QOL for the cancer located at the upper third of the stomach or at around the esophagogastric junction
Acronym
A study on the optimal gastrectomy procedures to improve postoperative QOL for the cancer located at the upper third of the stomach or at around the esophagogastric junction
Scientific Title
A study on the optimal gastrectomy procedures to improve postoperative QOL for the cancer located at the upper third of the stomach or at around the esophagogastric junction
Scientific Title:Acronym
A study on the optimal gastrectomy procedures to improve postoperative QOL for the cancer located at the upper third of the stomach or at around the esophagogastric junction
Region
| Japan |
Condition
Condition
The patients with cancer located at the upper third of the stomach or at around the esophagogastric junction who underwent various types of gastrectomy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the optimal gastrectomy procedures to improve postoperative QOL for the cancer located at the upper third of the stomach or at around the esophagogastric junction.
Basic objectives2
Others
Basic objectives -Others
To study the effect of various surgical procedures and clinical factors on postoperative QOL in each type of gastrectomy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The main outcome measures of PGSAS-45 and change in body weight are compared among the different type of gastrectomy for the cancer located at the upper third of the stomach or at the around the esophagogastric junction.
Key secondary outcomes
The effects of the surgical procedures and the clinical factors on postoperative QOL are studied in each type of gastrectomy.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) The patients with cancer located at the upper third of the stomach or at around the esophagogastric junction (with any stage or histologic type).
(2) Achieved R0 resection.
(3) Without any recurrence or metastasis.
(4) The patients who were more than 6 months after gastrectomy.
(5) Allowable of former chemotherapy if more than 6 months past after the termination of the treatment.
(6) The patients who underwent gastrectomy only once.
(7) Performance status 0 or 1.
(8) Capable to understand the questionnaire.
(9) Without any other disease or previous surgery which may influence the results of questionnaire more than gastrectomy.
(10) Without any organ failure or mental disease.
(11) Spontaneous agreement of the said person.
Key exclusion criteria
(1) Active dual malignancy.
(2) Synchronous another surgery with exception of the resection or the extraction of the perigastric organs to accomplish gastrectomy or lymph node dissection, and ones equivalent to cholecystectomy.
(3) Judged as irrelevant by the responsible doctor of this study.
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Nakada |
Organization
The Jikei University Daisan Hospital
Division name
Department of Laboratory Medicine
Zip code
201-8601
Address
4-11-1, Izumihoncyo, Komae-shi, Tokyo, 201-8601 Japan
TEL
03-3480-1151
nakada@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Nakada |
Organization
The Jikei University Daisan Hospital
Division name
Department of Laboratory Medicine
Zip code
201-8601
Address
4-11-1, Izumihoncyo, Komae-shi, Tokyo, 201-8601 Japan
TEL
03-3480-1151
Homepage URL
nakada@jikei.ac.jp
Sponsor or person
Institute
Japan Postgastrectomy Syndrome Working Party
Japanese Society for Gastro-surgical Pathophysiology
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Ethics Committee, The Jikei University School of Medicine
Address
3-25-8,Nishishimbashi, Minato-ku, Tokyo, 105-8461 Japan
Tel
03-3433-1111
rinri@jikei.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
東京慈恵会医科大学附属第三病院（東京都）、佐久市立国保浅間総合病院（長野県）、横浜市立市民病院消化器外科（神奈川県）、金沢医科大学（石川県）、国際医療福祉大学病院（栃木県）、今村総合病院（鹿児島県）、名古屋大学（愛知県）、東京大学（東京都）、横浜市立大学附属市民総合医療センター（神奈川県）、岐阜大学（岐阜県）、四国がんセンター（愛媛県）、新潟県立がんセンター新潟病院（新潟県）、がん研有明病院（東京都）、県立広島病院（広島県）、東京慈恵会医科大学附属病院（東京都）、 公立みつぎ総合病院（広島県）、順天堂大学（東京都）、函館五稜郭病院（北海道）、静岡県立静岡がんセンター（静岡県）、滋賀医科大学（滋賀県）、山形県立中央病院（山形県）、島根大学（島根県）、千葉県がんセンター（千葉県）、獨協医科大学（栃木県）、東邦大学医療センター大橋病院（東京都）、愛知県がんセンター中央病院（愛知県）、済生会川内病院（鹿児島県）、大阪医科大学（大阪府）、城山病院（大阪府）、京都府立医科大学（京都府）、大阪府済生会野江病院（大阪府）、堺市立総合医療センター（大阪府）、山梨大学（山梨県）、高知大学（高知県）、札幌医科大学（北海道）、鹿児島大学（鹿児島県）、大阪市立大学（大阪府）、勤医協中央病院（北海道）、呉医療センター・中国がんセンター（広島県）、東京医科大学（東京都）、おおもと病院（岡山県）、帝京大学（東京都）、箕面市立病院（大阪府）、前橋赤十字病院（群馬県）、石川県立中央病院（石川県）、南大阪病院（大阪府）、聖路加国際病院（東京都）、日赤和歌山医療センター（和歌山県）、大分県厚生連鶴見病院（大分県）、富山県立中央病院（富山県）、奈良県立医科大学（奈良県）、JA広島総合病院（広島県）、青森県立中央病院（青森県）、聖マリアンナ医科大学（神奈川県）、山口大学（山口県）、千葉大学（千葉県）、広島市立安佐市民病院（広島県）、 国立がん研究センター中央病院（東京都）、久留米大学（福岡県）、京都医療センター（京都府）、岐阜市民病院（岐阜県）、立川メディカルセンター（東京都）、北海道消化器科病院（北海道）、秋田厚生医療センター（秋田県）、大分大学（大分県）、鳥取大学（鳥取県）、名古屋市立大学（愛知県）、北野病院（大阪府）、大津市民病院（滋賀県）、京都大学（京都府）、広島市立広島市民病院（広島県）、広島大学（広島県）、熊本大学（熊本県）、岩手医科大学（岩手県）、栃木県立がんセンター（栃木県）、神戸大学（兵庫県）、仙台医療センター（宮城県）、長岡中央綜合病院（新潟県）、鈴鹿中央総合病院（三重県）、関西医科大学附属病院（大阪府）、宮城県立がんセンター（宮城県）、埼玉医科大学総合医療センター（埼玉県）、福山市民病院（広島県）、東海大学医学部付属八王子病院（東京都）、りんくう総合医療センター（大阪府）、九州大学（福岡県）、筑波大学（茨城県）、八尾市立病院（大阪府）、神奈川県立がんセンター（神奈川県）、関西労災病院（兵庫県）、弘前大学（青森県）、昭和大学藤が丘病院（神奈川県）、東海大学（神奈川県）、鳥取県立中央病院（鳥取県）、佐世保市総合医療センター（長崎県）、慶應義塾大学（東京都）、大阪急性期・総合医療センター（大阪府）、広島記念病院外科（広島県）、生麦病院（神奈川県）、佐久医療センター（長野県）、JCHO札幌北辰病院（北海道）、福岡大学病院（福岡県）、埼玉医科大学国際医療センター（埼玉県）、北里大学北里研究所病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 17 | 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
1909
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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 17 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 17 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 17 | Day |
Other
Other related information
(1) Date of birth, gastrectomy and entry in the questionnaire
(2) Sex
(3) Height, body weight (at just before gastrectomy and at entry in the questionnaire)
(4) Pathological stage, histological type, location of the cancer
(5) Presence or absence of either neoadjuvant or adjuvant chemotherapy, regimens
(6) The level of esophago-gastric or esophago-jejunal anastomosis
(7) Type of gastrectomy and reconstruction method
And so on
Management information
Registered date
| 2018 | Year | 04 | Month | 12 | Day |
Last modified on
| 2020 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036743
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