UMIN-CTR Clinical Trial

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
Email	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
Email	masayasu-horibe@umin.ac.jp

Sponsor
Institute	Keio University School of Medicine, Division of Gastroenterology and Hepatology Department of Internal Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028398