UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017106 |
|---|---|
| Receipt number | 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 03:20:26 |
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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
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
iwanohi6104@gmail.com
Sponsor or person
Institute
SKY study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019844
