UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020868 |
|---|---|
| Receipt number | R000024027 |
| Scientific Title | Continuous regional arterial infusion (CRAI) versus venous infusion of Nafamostat mesilate for severe acute pancreatitis: a multicenter, open-label, randomized controlled trial. |
| Date of disclosure of the study information | 2016/02/03 |
| Last modified on | 2020/03/27 19:59:58 |
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Basic information
Public title
Continuous regional arterial infusion (CRAI) versus venous infusion of Nafamostat mesilate for severe acute pancreatitis: a multicenter, open-label, randomized controlled trial.
Acronym
A randomized controlled trial to evaluate CRAI of Nafamostat mesilate for severe acute pancreatitis (CRAI-SAP study)
Scientific Title
Continuous regional arterial infusion (CRAI) versus venous infusion of Nafamostat mesilate for severe acute pancreatitis: a multicenter, open-label, randomized controlled trial.
Scientific Title:Acronym
A randomized controlled trial to evaluate CRAI of Nafamostat mesilate for severe acute pancreatitis (CRAI-SAP study)
Region
| Japan |
Condition
Condition
Severe acute pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and the safety of CRAI of Nafamostat mesilate for patients with severe acute pancreatitis presenting pancreatic ischemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of large extent of pancreatic necrosis determined by masked assessors using contrast-enhanced CT (CECT) images obtained at 2 weeks after starting the Nafamostat mesilate administration.
Key secondary outcomes
Extent of pancreatic necrosis. CT severity index. Degree of pain. Japanese severity score. Modified Marshall score. CRP. SIRS. Rate of necrosectomy. Mortality.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Participants in the experimental group undergo CRAI of Nafamostat mesialte (240mg/day) to the pancreas for 5 days
Interventions/Control_2
Participants in the control group undergo venous infusion of Nafamostat mesialte (240mg/day) for 5 days
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with severe acute pancreatitis who fulfill the Japanese CECT Grade 2 or 3 and who present hypo-enhanced lesion (<70HU) in more than one third of the pancreas detected by the CECT performed within 48 hours of the onset.
2. Aged between 20 and 79 years.
3. Administration of Nafamostat mesilate starts within 24 hours after the CECT.
4. Existence of legally acceptable representative.
Key exclusion criteria
1. Previous CRAI therapy for the same disease.
2. Previous therapy using Nafamostat mesilate >39mg/kg/day, Gabexate mesilate >39mg/kg/day or Ulinastatin >300,000U/day for the same disease.
3. Unclear the starting time of severe abdominal pain.
4. Patient with concurrent pancreatic cancer.
5. History of the pancreas resection.
6. eGFR<30mL/min/1.73m2.
7. Serous K>5.5mEq/L.
8. Pregnancy.
9. Allergy to iodine contrast medium.
10. Contraindication for angiography.
11. Allergy to Nafamostat mesilate.
12. Untolerable quality of CT image.
13. Serious underlying disease.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tooru |
| Middle name | |
| Last name | Shimosegawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Gastroenterology
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7171
tshimosegawa@int3.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Morihisa |
| Middle name | |
| Last name | Hirota |
Organization
Tohoku University Hospital
Division name
Gastroenterology
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7171
Homepage URL
morihirota@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital, Division of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MHLW Certified Clinical Research Review Board, Tohoku University
Address
2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan
Tel
022-718-0461
office@nrs.hosp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 03 | 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
| 2015 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 03 | Day |
Last modified on
| 2020 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024027
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/08/06 | C-21_治験実施計画書_第1.7版_160930.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
