UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001517 |
|---|---|
| Receipt number | R000001704 |
| Scientific Title | Multicenter comparative between 5 and 15 backward-oblique angle of duodenoscope for ERCP |
| Date of disclosure of the study information | 2008/11/20 |
| Last modified on | 2009/05/23 11:13:37 |
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Basic information
Public title
Multicenter comparative between 5 and 15 backward-oblique angle of duodenoscope for ERCP
Acronym
Multicenter comparative trial of duodenoscope for ERCP
Scientific Title
Multicenter comparative between 5 and 15 backward-oblique angle of duodenoscope for ERCP
Scientific Title:Acronym
Multicenter comparative trial of duodenoscope for ERCP
Region
| Japan |
Condition
Condition
Pancreaticobiliary disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary success rate of selective
CBD cannulation between 5 and 15 backward-oblique angle of duodenoscope for ERCP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The main outcome measurement was successful or failed selective cannulation of the CBD with wire-guided catheter or hydrophilic guidewire within a period of 10 minutes.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Historical
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Duodenoscope
Interventions/Control_2
Papillotome knife
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
All patients with an intact papilla were eligible for the study.
Key exclusion criteria
Exclusion criteria were the following: severe disturbance of consciousness; age below 20 years, acute illness (hypotension: systolic blood pressure below 90mmHg; hypoxia: oxygen saturation less than 95% on supplemental oxygen; hemodynamic instability), disseminated intravascular coagulation; sepsis; acute circulatory failure; severe heart disease; hepatic insufficiency, compromised renal dysfuncion;
a previous ERCP; acute pancreatitis; acute exacerbation of chronic pancreatitis; common bile duct stone impaction; ampullary neoplasm; Billroth II gastrectomy; Roue-en-Y reconstruction; separate orifices of the CBD and pancreatic duct on the papilla; pregnancy; breast-feeding women; women suspected of being pregnancy; refusal to participate in the study. Somebody who are found unifit to be patients by investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kawakami |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan
TEL
011-716-1161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kawakami |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo 060-8638, Japan
TEL
Homepage URL
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
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
Address
Tel
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
| 2008 | Year | 11 | Month | 20 | 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
Results
Success rates for bile duct cannulation by WGC without bow-up for the 15 degrees field of view and 5 degrees field of view were 87.5% and 57.5%, respectively (p<0.01). Success rates for bile duct cannulation by WGC with bow-up for the 15 degrees field of view and 5 degrees field of view groups were 90.9% and 80.5%, respectively. Total rates of bile duct cannulation for the 15 degrees and 5 degrees were 96.6% and 94.3%, respectively. As for accidents, incidences of acute pancreatitis for the 15 degrees and 5 degrees groups were 5.7% and 9.2%, respectively, with no significant difference seen.
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
| 2008 | Year | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 20 | Day |
Last modified on
| 2009 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001704
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
