UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009816 |
|---|---|
| Receipt number | R000011502 |
| Scientific Title | Comparison of pancrelipase and pancreatin for treatment of patients with pancreatic exocrine insufficiency due to pancreatic resection |
| Date of disclosure of the study information | 2013/01/20 |
| Last modified on | 2014/11/04 22:45:13 |
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Basic information
Public title
Comparison of pancrelipase and pancreatin for treatment of patients with pancreatic exocrine insufficiency due to pancreatic resection
Acronym
Pancrelipase vs. Pancreatin for treatment of pancreatc exocrine insufficiency due to pancreatic resection (PEC trial)
Scientific Title
Comparison of pancrelipase and pancreatin for treatment of patients with pancreatic exocrine insufficiency due to pancreatic resection
Scientific Title:Acronym
Pancrelipase vs. Pancreatin for treatment of pancreatc exocrine insufficiency due to pancreatic resection (PEC trial)
Region
| Japan |
Condition
Condition
Patients who will undergo pancreatectomy
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety outcomes of pancrealipase treatment on long term nutritional condition for patients with pancreatic resection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Increased level of serum albumin after treatment for 24 weeks compared with preoperative level.
Key secondary outcomes
1)nutrient assessment
2)condition of stool
3)Body composition(%)
4)edema
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pancrelipase group:
600mg of pancrelipase to be taken three times a day (1800mg /day) after meals for 24weeks.
Interventions/Control_2
Pancreatin group:
One gram of pancreatin to be taken three times a day (3g /day) after meals for 24weeks.
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)Patients who are scheduled to undergo pancreticoduodenectomy or distal pancreatectomy or total pancreatectomy
2)No prior therapy of pancreatic surgery
3)Written informed consent.
4)Age of at least 20 years old at the time of registration.
5)Performance status of 0 or 1.
Key exclusion criteria
1)Case with possibility of pregnancy or during nursing
2)Sever infection
3)Malabsorption syndrome without pancreatic disease
4)Alegyin porcine or bovine protein or digestive enzym
5)Participates in other examinations of pancreatic exocrine insufficiency.
6)The case judged to be inappropriate for the examination to carry out this study safely by attending doctor
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Miyazaki |
Organization
Chiba University Hospital
Division name
Hepatobiliary Pancreatic Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, 260-8677, JAPAN
TEL
81-43-222-7171
masaru@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Yoshitomi |
Organization
Chiba University Hospital
Division name
Hepatobiliary Pancreatic Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, 260-8677, JAPAN
TEL
043-222-7171
Homepage URL
yoshitomi@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University, Graduate School of Medicine, Department of General Surgery
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
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
| 2013 | Year | 01 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
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
| 2013 | Year | 01 | Month | 20 | Day |
Last modified on
| 2014 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011502
