UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054241 |
|---|---|
| Receipt number | R000061939 |
| Scientific Title | Attempt to develop a pattern recognition scoring system predicting the difficulty of bile duct cannulation during ERCP to select conventional or salvage method |
| Date of disclosure of the study information | 2024/04/24 |
| Last modified on | 2024/04/24 07:41:29 |
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Basic information
Public title
Attempt to develop a pattern recognition scoring system predicting the difficulty of bile duct cannulation during ERCP to select conventional or salvage method
Acronym
New scoring system predicting difficulty in ERCP
Scientific Title
Attempt to develop a pattern recognition scoring system predicting the difficulty of bile duct cannulation during ERCP to select conventional or salvage method
Scientific Title:Acronym
New scoring system predicting difficulty in ERCP
Region
| Japan |
Condition
Condition
biliary tract disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify patterns of cannulation difficulties and develop a predictive system for cannulation method selection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The success rate of deep bile duct cannulation using the conventional contrast method for several recognition patterns.
Key secondary outcomes
Precut sphincterotomies and adverse event rates.
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients underwent ERCP at our hospital between April 2021 and September 2023 with naive papillae of Vater are enrolled in this study.
Key exclusion criteria
Exclusion criteria include patients who underwent the procedure for the second or subsequent times, previous endoscopic sphincterotomy, use of a forward-viewing endoscope or balloon-assisted enteroscopy was used, and discontinuation of treatment for anatomic reasons such as intestinal stenosis.
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Taira |
| Middle name | |
| Last name | Kuroda |
Organization
Ehime Prefectural Central Hospital
Division name
Gastroenterology Center
Zip code
790-0925
Address
Kasugamachi, Matsuyama, Ehime 790-0925, Japan
TEL
+81-89-947-1111
taira.k.0120@gmail.com
Public contact
Name of contact person
| 1st name | Taira |
| Middle name | |
| Last name | Kuroda |
Organization
Ehime Prefectural Central Hospital
Division name
Gastroenterology Center
Zip code
790-0925
Address
Kasugamachi, Matsuyama, Ehime 790-0925, Japan
TEL
+81-89-947-1111
Homepage URL
taira.k.0120@gmail.com
Sponsor or person
Institute
Gastroenterology Center, Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan
Institute
Department
Personal name
Funding Source
Organization
Gastroenterology Center, Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of the Ehime Prefectural Central Hospital
Address
Kasugamachi, Matsuyama, Ehime 790-0925, Japan
Tel
+81-89-947-1111
chuo-byoin@pref.ehime.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 24 | 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
776
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
| 2024 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients underwent ERCP at our hospital between April 2021 and September 2023 with naive papillae of Vater are enrolled in this study. Electronic medical records are used to extract data regarding patient age, sex, body mass index, and endoscopic procedures. Patient data related to the ERCP procedure are recorded, including cannulation success or failure, precut sphincterotomy, final cannulation method (conventional contrast cannulation or salvage techniques), pancreatic stenting, trainee operator, reason for ERCP implementation (benign or malignant), and adverse events. Major duodenal papilla morphology is evaluated using endoscopic recordings and images.
The primary outcome of this study is the rate of deep bile duct cannulation difficulty using pattern recognition. We analyze the success rate of deep cannulation using the conventional contrast method and compared it to that of salvage techniques for several recognition patterns. Factors that may increase the risk of requiring salvage techniques are analyzed using multiple regression analysis and scored based on these results. The secondary outcomes include precut sphincterotomies and adverse event rates.
Management information
Registered date
| 2024 | Year | 04 | Month | 24 | Day |
Last modified on
| 2024 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061939
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