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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017106
Receipt No. R000019844
Scientific Title Low-dose rectal NSAIDs for prevention of post-ERCP pancreatitis -randomized controlled multicenter study- : Loren study
Date of disclosure of the study information 2015/05/01
Last modified on 2019/04/25

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Basic information
Public title Low-dose rectal NSAIDs for prevention of post-ERCP pancreatitis -randomized controlled multicenter study- : Loren study
Acronym Loren study
Scientific Title Low-dose rectal NSAIDs for prevention of post-ERCP pancreatitis -randomized controlled multicenter study- : Loren study
Scientific Title:Acronym Loren study
Region
Japan

Condition
Condition Pancreaticobiliary disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Pancreatitis remains the most common complication of ERCP, occurring after 1% to 15% of procedures. Severe pancreatitis occurs in 0.1% to 1.0% of patients in unselected prospective series. It is reported that rectal NSAIDs significantly reduced the incidence of Post-ERCP pancreatitis. However, the rectal NSAID dose used in these trials was 100 mg of diclofenac or indomethacin, which is higher than the normal single dose used in Japan. We conducted a prospective randomized controlled trial to evaluate the efficacy of low-dose rectal NSAIDs for the prevention of Post-ERCP pancreatitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of Post-ERCP pancreatitis
Key secondary outcomes The incidence of Hyperamylasemia
The incidence of abdominal pain after ERCP
Cost effectiveness

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 May 2015-March 2019
Post-ERCP pancreatitis low risk
Diclofenac non-administration
Interventions/Control_2 May 2015-March 2019
Post-ERCP pancreatitis low risk
Low dose diclofenac administration
Interventions/Control_3 May 2015-March 2019
Post-ERCP pancreatitis high risk
Diclofenac non-administration
Interventions/Control_4 May 2015-March 2019
Post-ERCP pancreatitis high risk
Low dose diclofenac administration
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
80 years-old >
Gender Male and Female
Key inclusion criteria The patient who needs ERCP.
Possible of endoscopic approach.
Normal stomach or Billroth I reconstruction stomach.
Non previous EST in patients who planned biliary treatment.
The patient who does not cause pancreatitis.
The patient who does not use the NSAIDs within 24 hours.
Main pancreatic duct < 4mm.
Key exclusion criteria Endoscopic papillectomy.
The patient who was inserted EPS or ENPD.
CCr<60ml/min.
Systolic blood pressure < 100mmHg before ERCP.
Active peptic ulcer.
Rectal ulcer or Rectal cancer.
Aspirin-induced asthma.
NSAIDs allergy.
Triamterene oral administration.
Sever cardiovascular disease.
During pregnancy or lactating.
Patients not to consent.
ECOG Performance Status 4.
The patient who admitted that it was inappropriate though the chief physician carried out the examination.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Hirotoshi
Middle name
Last name Iwano
Organization Shibetsu City Hospital
Division name Gastroenterology
Zip code 095-0048
Address 3029-1, Higashi 11-5, Shibetsu-shi, Hokkaido
TEL 0165-23-2166
Email iwanohi6104@gmail.com

Public contact
Name of contact person
1st name Hirotoshi
Middle name
Last name Iwano
Organization Shibetsu City Hospital
Division name Gastroenterology
Zip code 095-0048
Address 3029-1, Higashi 11-5, Shibetsu-shi, Hokkaido
TEL 0165-23-2166
Homepage URL
Email iwanohi6104@gmail.com

Sponsor
Institute SKY study group
Institute
Department

Funding Source
Organization None
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 Shibetsu City Hospital IRB
Address 3029-1, Higashi 11-5, Shibetsu-shi, Hokkaido
Tel 0165-23-2166
Email byouinsohmuka@city.shibetsu.lg.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 久留米大学病院(福岡県)、九州医療センター(福岡県)、徳山中央病院(山口県)、埼玉医科大学国際医療センター(埼玉県)、済生会川内病院(鹿児島県)、鹿児島大学病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 01 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 Terminated
Date of protocol fixation
2015 Year 03 Month 16 Day
Date of IRB
2015 Year 04 Month 01 Day
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 04 Month 30 Day
Date analysis concluded
2019 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 11 Day
Last modified on
2019 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019844

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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