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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000034018 |
Receipt No. | R000037942 |
Scientific Title | A prospective clinical study of a prophylactic treatment for postgastrectomy pancreatic fistula |
Date of disclosure of the study information | 2018/09/06 |
Last modified on | 2018/09/04 |
Basic information | ||
Public title | A prospective clinical study of a prophylactic treatment for postgastrectomy pancreatic fistula | |
Acronym | A prospective clinical study of a prophylactic treatment for postgastrectomy pancreatic fistula | |
Scientific Title | A prospective clinical study of a prophylactic treatment for postgastrectomy pancreatic fistula | |
Scientific Title:Acronym | A prospective clinical study of a prophylactic treatment for postgastrectomy pancreatic fistula | |
Region |
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Condition | ||
Condition | Gastric cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | validate a prophylactic use of a fibrin glue sealant according to a prediction of postgastrectomy pancreatic fistula |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | postgastrectomy pancreatic fistula |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Historical |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | using fibrin glue sealant according to a prediction of postgastrectomy pancreatic fistula | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) gastric cancer for which distal gastrectomy, proximal gastrectomy, or total gastrectomy with lymph node dissection
2) the ability to undergo anesthesia with an Eastern Cooperative Oncology Group performance status of 0 to 2 3) an age of 20 to 90 years 4) provision of written informed consent |
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Key exclusion criteria | 1) a requirement for pancreatectomy for treatment of pancreatic invasion
2) a requirement for lower mediastinal lymph node dissection or anastomosis in the mediastinal 3) severe injury of other organs 4) inadequacy for patient participation in the study as determined by the investigators |
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Target sample size | 130 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Graduate School of Medicine, Tokyo Medical and Dental University | ||||||
Division name | Minimally Invasive Treatment | ||||||
Zip code | |||||||
Address | Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan | ||||||
TEL | 03-5803-5260 | ||||||
k-kojima.srg2@tmd.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Medical Hospital, Tokyo Medical and Dental University | ||||||
Division name | Gastric Surgery | ||||||
Zip code | |||||||
Address | Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan | ||||||
TEL | 03-5803-4525 | ||||||
Homepage URL | |||||||
tanioka.srg1@tmd.ac.jp |
Sponsor | |
Institute | Tokyo Medical and Dental University |
Institute | |
Department |
Funding Source | |
Organization | none |
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 | |
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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 |
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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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037942 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |