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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020868
Receipt No. 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

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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
Email 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
Email morihirota@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital, Division of Gastroenterology
Institute
Department

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
Email 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
URL(English) https://upload.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


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