UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005758 |
|---|---|
| Receipt number | R000006688 |
| Scientific Title | Prospective study of pancreatic exocrine function after pancreaticoduodenectomy |
| Date of disclosure of the study information | 2011/06/15 |
| Last modified on | 2019/04/17 13:03:58 |
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Basic information
Public title
Prospective study of pancreatic exocrine function after pancreaticoduodenectomy
Acronym
Prospective study of pancreatic exocrine function after pancreaticoduodenectomy
Scientific Title
Prospective study of pancreatic exocrine function after pancreaticoduodenectomy
Scientific Title:Acronym
Prospective study of pancreatic exocrine function after pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
Periampullary tumor
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the difference of pancreatico-enteric anastomosis in long-term pancreatic exocrine function after pancreaticoduodenectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Incidence of pancreatic exocrine inefficiency one year after surgery
Key secondary outcomes
The Incidence of pancreatic exocrine inefficiency three months and two year after surgery
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
| Maneuver |
Interventions/Control_1
Duct-to-mucosa pancreatico-gastrostomy for pancreatico-enterostomy
Interventions/Control_2
Duct-to-mucosa pancreatico-jejunosotmy for pancreatico-enterostomy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
On the diagnosis of periampullary malignancy, benign tumor or inflammatory disease, the patient is going to undergo pancreaticoduodenectomy with duodeno-jejunostomy
Key exclusion criteria
1.Patients with acute ischemic heart disease
2.Patients with liver cirrhosis or active hepatitis
3. Patients with interstitial pneumonia or fibroid lung who require oxygen administration
4. Patients with chronic renal failure requiring dialysis
5. Patients with other malignant disease
6. Patients who require concomitant resection of other organ
7. Patients who are diagnosed to be ineligible by the investigator.
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Murakami |
Organization
Hiroshima University Hospital
Division name
Gastrointestinal Surgery
Zip code
Address
1-2-3Kasumi, Minamiku, Hiroshima
TEL
082-257-5216
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Uemura |
Organization
Hiroshima University Hospital
Division name
Gastrointestinal Surgery
Zip code
Address
1-2-3Kasumi, Minamiku, Hiroshima
TEL
082-257-5216
Homepage URL
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Wakayama Medical University
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
広島大学病院（広島県）、和歌山県立医科大学病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 15 | 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
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 11 | Day |
Last modified on
| 2019 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006688
