UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025468 |
|---|---|
| Receipt number | R000028398 |
| Scientific Title | Multicenter prospective study in acute pancreatitis |
| Date of disclosure of the study information | 2016/12/30 |
| Last modified on | 2022/07/05 00:19:55 |
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Basic information
Public title
Multicenter prospective study in acute pancreatitis
Acronym
SANADA(multicenter proSpective cohort in pAtieNts with severe And milD Acute pancreatitis) study
Scientific Title
Multicenter prospective study in acute pancreatitis
Scientific Title:Acronym
SANADA(multicenter proSpective cohort in pAtieNts with severe And milD Acute pancreatitis) study
Region
| Japan |
Condition
Condition
acute pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate short-term and long-term outcomes of acute pancreatitis. To evaluate the efficacy and safety of various treatment in acute pancreatitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Hospital mortality
Key secondary outcomes
Mortality within 14 days
Mortality associated with pancreatitis
Mortality after discharge at 1 year, 2years, 3years, 4years and 5 years and 5 years from admission
Proportion which mild acute pancreatitis became severe acute pancreatitis based on the criteria of the Japanese Ministry of Health, Labour and Welfare study group for acute pancreatitis severity (2008)within 7 days
The Rivised Atlanta classification within 7 days
Transient(<=48h) and persistent(>48h) organ failure by Modified Marshall scoring system(respiratory, renal and cardiovascular)within 7 days
Cotton classification
Repiratory failure which need ventilator
Renal failure which need dialysis
Cardiovascular failure which need catecholamine
Secondary infection in pancreatic necrosis
Bacteremia
Candida infection
Modified CTSI(during 1 week to 4 weeks and, 4 weeks to 12 weeks, from occur)
Walled-off necrosis(during 1 week to 4 weeks and, 4 weeks to 12 weeks, from occur)
Surgical intervention(percutaneous, endoscopic, laparoscopic or laparotomy drainage or necrosectomy for infected acute necrotic collection or walled-off necrosis, interventional radiology or endoscopic treatment for bleeding,surgery for bowel necrosis or abdominal compartment syndrome Abdominal compartment syndrome, ECMO or IABP etc)
Length of hospital and ICU stay
The proportion of patients who discharge to home
Disturbance in endocrine functionat(DM or inslin use) at discharge, 1 year, 2years, 3years, 4years and 5 years from admission
Disturbance in exocrine functionat at discharge, 1 year, 2years, 3years, 4years and 5 years from admission
The rate of chronic pancreatitis
The rate of cancer
The rate of pancreatitis recurrence
The rate of multiple-drug-resistant bacteria
Maximum of CRP value
Decline rate of TG
QOL(EQ-5D-5L)
Cost
QALY
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who are diagnosed with acute pancreatitis will be included. The definition of acute pancreatitis requires 2 of the following 3 features: 1.upper abdominal pain of acute onset often radiating through to the back, 2.serum amylase or lipase activity greater than 3 times the upper limit of normal, 3.findings on cross sectional abdominal imaging consistent with acute pancreatitis.
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Kanai |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-5363-3790
takagast@z2.keio.jp
Public contact
Name of contact person
| 1st name | Masayasu |
| Middle name | |
| Last name | Horibe |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-5363-3790
Homepage URL
masayasu-horibe@umin.ac.jp
Sponsor or person
Institute
Keio University School of Medicine, Division of Gastroenterology and Hepatology Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Keio University School of Medicine ethical committee
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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 | 12 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2027 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: prospective cohort study
Study duration:2017 to 2027
Objective:All consecutive patients with acute pancreatitis
Investigation items:
Speciality with main treatment
Gender
Age
Etiology
History of smoking
Drinking history
Date and time of onset
Date and time of diagnosis
Date of admission
Past history
Body height
Body weight
Body mass index
Charlson Risk Index
Albumin,Total bilirubin,LDH,BUN,Creatinine
Na,K,Ca,TG, WBC, CRP, Hct, blood platelet, pH, pO2, pCO2, lactate,BE, HCO3, SpO2, FiO2, body temperature, systolic arterial pressure, diastolic arterial pressure, mean arterial blood pressure, heart rate, respiratory rate
Glasgow coma scale(GCS)
Prognostic factor score(admission, 0-24h,24-48h)
Date and time of Computerized tomography(CT)
CT finding(part of low enhanced pancreatic parenchyma)
CT grade
Modified CT severity index
APACHEII(admission,0-24h,24-48h,48-72h)
Sepsis-related Organ Failure Assessment score
Bedside index for severity in acute pancreatitis
Harmless acute pancreatitis score
Panc 3
Pancreatitis Outcome Prediction score
PASS
Deterinant-Based Classification
Cotton Classification
Revised Atlanta Classification
Date and kind of oral intake
Date, method and kind of enteral alimentation
The amount of protein and calorie(from day1 to 7)
Administered fluid volume and kind(0-6h, 0-12h, 0-24h, 24-48, 48-72)
Central vein catheter
Start time, length and method of continuous regional arterial infusion
Start time, length and method of preventive antibiotics
Use of antibiotics for infection
Implementation of de-escalation
Use of protease Inhibitors
The presence of disseminated intravascular coagulation and treatment
Japanese Association for Acute Medicine disseminated intravascular coagulation scoring system
The method of plasmapheresis
Non-renal indication Renal Replacement Therapy
Start Time of endoscopic retrograde cholangiopancreatography for gallstone pancreatitis
Adherence rate of bandle in Japanese guideline
Management information
Registered date
| 2016 | Year | 12 | Month | 28 | Day |
Last modified on
| 2022 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028398
