UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025727 |
|---|---|
| Receipt number | R000029598 |
| Scientific Title | Effect of endoscopic transpapillary biliary drainage with/without endoscopic sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis in patients with biliary stricture |
| Date of disclosure of the study information | 2017/01/18 |
| Last modified on | 2021/09/22 19:10:45 |
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Basic information
Public title
Effect of endoscopic transpapillary biliary drainage with/without endoscopic sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis in patients with biliary stricture
Acronym
E-BEST
Scientific Title
Effect of endoscopic transpapillary biliary drainage with/without endoscopic sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis in patients with biliary stricture
Scientific Title:Acronym
E-BEST
Region
| Japan |
Condition
Condition
Biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the non-inferiority of biliary drainage without endoscopic sphincterotomy (ES) compared to with ES in point of the incidence of post endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of post ERCP pancreatitis after biliary stenting (plastic stent:PS or endoscopic naso-biliary drainage:NB) for naive major duodenal papilla.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Non-adding endoscopic sphincterotomy (non-ES)
Interventions/Control_2
Adding endoscopic sphincterotomy (ES)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with biliary stricture confirmed by images, need for drainage.
2.Patients with biliary stricture need for placement of PS or NB as initial transpapillary biliary drainage.
3.Patients who are 20 years of age or older
4.Patients with informed consent
Key exclusion criteria
1.Patients with history of ERCP
2.Patients with history of gastrointestinal tract reconstruction
3.Patients with symptoms of acute pancreatitis
4.Impossible to reach to major duodenal papilla by duodenal endoscope
5.Patients with bleeding diathesis
6.Patients with severe cholangitis
7.ECOG-PS 4
8.Patients with pancreaticobiliary maljunction
9.Patients with severe cardiopulmonary disease
10.Expectant mother or lactating mother
11.Patients with tumor of papilla vater
12.Impossible to cannulate bile duct.
13.Patients that the physician in charge consider not suitable for inclusion
Target sample size
370
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy/Department of Gastroenterology and Hepatology
Zip code
060-8648
Address
Kita 14,Nishi 5,Kita-ku,Sapporo, Hokkaido
TEL
011-716-1161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Kato |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8648
Address
Kita 14,Nishi 5,Kita-ku,Sapporo, Hokkaido
TEL
011-716-1161
Homepage URL
katoshin@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology,Hokkaido University, Graduate school of medicine.
Institute
Department
Personal name
Funding Source
Organization
The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Clinical Research Administration Center
Address
Kita 15,Nishi 7,Kita-ku,Sapporo,Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2017 | Year | 01 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
370
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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 18 | Day |
Last modified on
| 2021 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029598
