UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036714 |
|---|---|
| Receipt number | R000040818 |
| Scientific Title | The effect of endoscopic sphincterotomy in prevention of post-ERCP pancreatitis after metallic stent placement in patients with malignant distal biliary obstruction except pancreatic cancer; Multicenter observational study |
| Date of disclosure of the study information | 2019/05/13 |
| Last modified on | 2019/05/11 22:40:00 |
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Basic information
Public title
The effect of endoscopic sphincterotomy in prevention of post-ERCP pancreatitis after metallic stent placement in patients with malignant distal biliary obstruction except pancreatic cancer; Multicenter observational study
Acronym
The effect of MS placement without ES for malignant distal biliary obstruction except pancreatic cancer on prevention of PEP
Scientific Title
The effect of endoscopic sphincterotomy in prevention of post-ERCP pancreatitis after metallic stent placement in patients with malignant distal biliary obstruction except pancreatic cancer; Multicenter observational study
Scientific Title:Acronym
The effect of MS placement without ES for malignant distal biliary obstruction except pancreatic cancer on prevention of PEP
Region
| Japan |
Condition
Condition
Malignant distal biliary stricture due to bile duct cancer, gall bladder cancer, cystic duct cancer, ampullary cancer and lymph node metastasis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of non-adding endoscopic sphincterotomy prior to metalic stent placement in the patients with distal malignant biliary obstruction except pancreatic cancer in multicenter, retrospective setting.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of post-ERCP pancreatitis
Key secondary outcomes
1)Incidence of cholangitis, bleeding and perforation after ERCP
2)Serum amylase level before and after ERCP
3)Incidence of Stent dysfunction and Patency period of stent
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with distal malignant biliary obstruction
2. Patients who underwent transpapillary metalic stent placement by means of ERCP
3. Patients who are 20 years of age or older
Key exclusion criteria
1. Former history of endoscopic sphinterotomy before metalic stent placement
2. Patients with pancreatic cancer
3. Patients that the physician in charge consider not suitable for inclusion
Target sample size
183
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
0608638
Address
kita-ku, kita15, nishi7
TEL
0117161161
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
0608638
Address
kita-ku, kita15, nishi7
TEL
0117161161
Homepage URL
katoshin@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Hokkaido University Hospital IRB
Address
kita-ku, kita15, nishi7
Tel
0117161161
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
| 2019 | Year | 05 | Month | 13 | 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
183
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 05 | Month | 11 | Day |
Last modified on
| 2019 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040818
