UMIN-CTR Clinical Trial

Public title

The benefit of immediate oral intake of low-fat solid diet in mild acute pancreatitis: multicenter randomized control study

Acronym

RAPID study

Scientific Title

The benefit of immediate oral intake of low-fat solid diet in mild acute pancreatitis: multicenter randomized control study

Scientific Title:Acronym

RAPID study

Region

Japan

Condition

Acute pancreatitis

Classification by specialty

Hepato-biliary-pancreatic medicine	Hepato-biliary-pancreatic surgery	Emergency medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the efficacy and the safety of immediate oral intake of low-fat solid diet in patients with mild acute pancreatitis

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

Percentage diagnosed with moderately severe or severe by the revised Atlanta classification with day 4.

Key secondary outcomes

Percentage diagnosed with severe by the revised Atlanta classification with day 4.
Percentage diagnosed with moderately severe or severe by the revised Atlanta classification during admission(within two weeks).
Percentage diagnosed with severe by the revised Atlanta classification during admission(within two weeks).
Percentage diagnosed as severe using the prognostic factor according to the severity criteria of the Ministry of Health, Labor and Welfare with day 4.
In-hospital mortality
In-hospital mortality due to pancreatitis
Number of days until disappearance of abdominal pain
Abdominal pain relapse rate
Number of days from diagnosis of pancreatitis to healing
length of hospital stay
The changes in CRP and Ca level(from day 0 to day 2 and from day 0 to day 4)
Cost
Hospitalization rate due to recurrence of pancreatitis within 4 weeks after discharge

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Start low-fat solid food immediately (within 48 hours from diagnosis even if it is late) while allowing the use of an analgesics.

Interventions/Control_2

Gradually increase the amount of fat of diet after fasting with no food.
The criteria for starting meals shall satisfy all of the following 1) to 3).
1) An analgesic is not used for more than 24 hours.
2) Abdominal pain and abdominal tenderness are not prominent.
Abdominal pain is evaluated by WONG-BAKER Face (6 stages 0.2.4.6.8.10), and more than 6 is defined as prominent.
Abdominal tenderness WONG-BAKER Face (6 stages 0.2.4.6.8.10) is evaluated, and 6 or more is made prominent.
3) AMY is less than twice the standard upper limit of each facility
The standard for increasing the amount of lipid is the case where above 1) 2) is satisfied and the average intake amount of three meals of the same lipid amount is 50% or more.
Step 1:starvation
Steo 2:Form; not solid, fat; less than 5 g per day
Step 3:Form; any form, fat; 5 g or more and less than 15 g per day
Step 4:Form; solid, fat; 15 or more - 35 or less g per day

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

16

years-old

<=

Age-upper limit

95

years-old

>=

Gender

Male and Female

Key inclusion criteria

The patients who diagnosed with acute pancreatitis

Requires 2 of the following three features
1.upper abdominal pain of acute onset often radiating through to the back
2.serum amylase or lipase activity greater than three times the upper limit of normal
3.findings on cross-sectional abdominal imaging consistent with acute pancreatitis.

The patients who had less than 2 points by Modified Marshall scoring system
Respiratory: PaO2/FiO2>=301
Renal: Creatinine<=1.8mg/dl
Cardiovascular: systolic blood pressure>=90mmHg or systolic blood pressure>=90mmHg with fluid responsive

Key exclusion criteria

1)Patients with pancreatitis caused by obstruction of the pancreatic duct and have not been resolved the obstruction
2)Patients who have a complication of cholangitis
3)Traumatic pancreatitis
4)Patients who are not able to eat solid food due to the reduction of swallowing function
5)Patients who are not able to eat solid food due to consciousness disturbance
6)Patients who can not expect sufficient dietary intake
7)Patients with paralytic ileus by CT or ultrasound
8)Patients who regularly take medicine for pain with chronic pancreatitis
9)Patient judged inappropriate for this study by the attending physician
10)Patients who are older than 1 week after the onset of pancreatitis
11) Patients who do not agree with this study

Target sample size

626

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

03-5363-3790

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

03-5363-3790

Homepage URL

Email

aries24sirius@yahoo.co.jp

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee, Keio University School of Medicine

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

Tel

03-5363-3611

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

2018

Year

09

Month

26

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

Open public recruiting

Date of protocol fixation

2018

Year

09

Month

10

Day

Date of IRB

2018

Year

09

Month

26

Day

Anticipated trial start date

2020

Year

09

Month

18

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

09

Month

26

Day

Last modified on

2020

Year

09

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038983