UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036714
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email katoshin@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Department of Gastroenterology and Hepatology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040818

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.