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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000042245 |
Receipt No. | R000046863 |
Scientific Title | Can we prevent pancreatic fistula after distal pancreatectomy by delaying the initiation of food intake? A randomized controlled trial day4 vs day7. |
Date of disclosure of the study information | 2020/11/30 |
Last modified on | 2020/10/26 |
Basic information | ||
Public title | Can we prevent pancreatic fistula after distal pancreatectomy by delaying the initiation of food intake? A randomized controlled trial day4 vs day7. | |
Acronym | Can we prevent pancreatic fistula after DP by delaying the initiation of food intake? A randomized controlled trial day4 vs day7. | |
Scientific Title | Can we prevent pancreatic fistula after distal pancreatectomy by delaying the initiation of food intake? A randomized controlled trial day4 vs day7. | |
Scientific Title:Acronym | Can we prevent pancreatic fistula after distal pancreatectomy by delaying the initiation of food intake? A randomized controlled trial day4 vs day7. | |
Region |
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Condition | ||
Condition | Patients scheduled to undergo distal pancreatectomy regardless of primary disease, whether open or laparoscopic | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To analyze the impact of the timing of meal initiation after distal pancreatectomy on the incidence of pancreatic fistula incidence using a randomized controlled trial and to establish an appropriate postoperative management plan in our hospital. |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Incidence of post-operative pancreatic fistula |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Cluster |
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 |
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Interventions/Control_1 | The timing of the initiation of food intake after distal pancreatectomy POD4 | |
Interventions/Control_2 | The timing of the initiation of food intake after distal pancreatectomy POD7 | |
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 scheduled to undergo distal pancreatectomy regardless of primary disease, whether open or laparoscopic | |||
Key exclusion criteria | Patients for whom it is deemed necessary to perform a gastrointestinal resection or gastrointestinal anastomosis due to medical reasons | |||
Target sample size | 66 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Asahikawa Medical University | ||||||
Division name | Hepato-Biliary-Pancreatic and Transplant Surgery | ||||||
Zip code | 0788510 | ||||||
Address | 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido | ||||||
TEL | 0166682503 | ||||||
kimai@asahikawa-med.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Asahikawa Medical University Hospital | ||||||
Division name | Hepato-Biliary-Pancreatic and Transplant Surgery | ||||||
Zip code | 0788510 | ||||||
Address | 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido | ||||||
TEL | 0166682503 | ||||||
Homepage URL | |||||||
kimai@asahikawa-med.ac.jp |
Sponsor | |
Institute | Asahikawa Medical University |
Institute | |
Department |
Funding Source | |
Organization | Asahikawa Medical University |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Asahikawa Medical University |
Address | 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido |
Tel | 0166682503 |
kimai@asahikawa-med.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 | 旭川医科大学病院
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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=R000046863 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |