UMIN-CTR Clinical Trial

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

acute pancreatitis

Classification by specialty

Hepato-biliary-pancreatic medicine	Emergency medicine	Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

12

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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

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