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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000016866 |
Receipt No. | R000019574 |
Scientific Title | A clinical trial of a new criteria for drain removal after pancreaticoduodenectomy |
Date of disclosure of the study information | 2015/03/22 |
Last modified on | 2015/03/22 |
Basic information | ||
Public title | A clinical trial of a new criteria for drain removal after pancreaticoduodenectomy | |
Acronym | A clinical trial of a new criteria for drain removal after pancreaticoduodenectomy | |
Scientific Title | A clinical trial of a new criteria for drain removal after pancreaticoduodenectomy | |
Scientific Title:Acronym | A clinical trial of a new criteria for drain removal after pancreaticoduodenectomy | |
Region |
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Condition | ||
Condition | Periampullary diseases | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To apply the new criteria for drain removal after pancreaticoduodenectomy in order to decrease the rate of pancreatic fistula and to decrease the rate of interventional drainage or relaparotomy. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Rate of pancreatic fistula (Grade B or C) |
Key secondary outcomes | BMI, comorbidity, preoperative steroids, operation time, intraoperative blood loss, years of experience of surgeons, pancreatic parencyma, rate of pancreatic fistula(Grade A), rate of bleeding after surgery, rate of intraperitoneal abscess, rate of interventional drainage, rate of relaparotomy, rate of DGE, postoperative pancreatitis, postoperative cholangitis, SSI, rate of morbidity, length of drain insertion, hospital stay, mortality, rate of readmission |
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 | Treatment | |
Type of intervention |
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Interventions/Control_1 | New criteria for drain removal | |
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 | Patients received pancreaticoduodenectomy for periampullary diseases | |||
Key exclusion criteria | Patients with severe comorbidity
Patients with dysfunction of vital organs |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Yokohama City University | ||||||
Division name | Department of Gastroenterological Surgery | ||||||
Zip code | |||||||
Address | 3-9 Fukuura, Kanazawa-ku, Yokohama city | ||||||
TEL | 045-787-2650 | ||||||
t1006koichi@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Yokohama City University | ||||||
Division name | Department of Gastroenterological Surgery | ||||||
Zip code | |||||||
Address | 3-9 Fukuura, Kanazawa-ku, Yokohama city | ||||||
TEL | 045-787-2650 | ||||||
Homepage URL | |||||||
t1006koichi@yahoo.co.jp |
Sponsor | |
Institute | Yokohama City 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 | |
Address | |
Tel | |
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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
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=R000019574 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |