UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057247 |
|---|---|
| Receipt number | R000065436 |
| Scientific Title | Prospective evaluation of minimal endoscopic sphincterotomy with papillary balloon dilation using a novel sphincterotome and balloon catheter in balloon enteroscopy-assisted ERCP |
| Date of disclosure of the study information | 2025/03/09 |
| Last modified on | 2025/03/09 17:49:51 |
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Basic information
Public title
Prospective evaluation of minimal endoscopic sphincterotomy with papillary balloon dilation using a novel sphincterotome and balloon catheter in balloon enteroscopy-assisted ERCP
Acronym
Prospective evaluation of minimal endoscopic sphincterotomy with papillary balloon dilation using a novel sphincterotome and balloon catheter in balloon enteroscopy-assisted ERCP
Scientific Title
Prospective evaluation of minimal endoscopic sphincterotomy with papillary balloon dilation using a novel sphincterotome and balloon catheter in balloon enteroscopy-assisted ERCP
Scientific Title:Acronym
Prospective evaluation of minimal endoscopic sphincterotomy with papillary balloon dilation using a novel sphincterotome and balloon catheter in balloon enteroscopy-assisted ERCP
Region
| Japan |
Condition
Condition
Common bile duct stones
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and efficacy of minimal endoscopic sphincterotomy with papillary balloon dilation using a novel sphincterotome and balloon catheter in balloon enteroscopy-assisted ERCP
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success
Key secondary outcomes
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 small common bile duct stones
2) Patients with surgically altered anatomy
3) Patients with the duodenal papilla
Key exclusion criteria
1) Patients having difficulty in transpapillary approach
2) Patients with biliary reconstruction
3) Patients with biliary stricture
4) Patients with biliary tumor
5) Patients with severe cholangitis
6) Patients with pancreatitis
7) Patients who have undergone endoscopic sphincterotomy or papillary balloon dilation
8) Inappropriate patients for entry on this study in the judgement of their research investigator or physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tadahisa |
| Middle name | |
| Last name | Inoue |
Organization
Aichi Medical University
Division name
Department of Gastroenterology
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561623311
tinoue-tag@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tadahisa |
| Middle name | |
| Last name | Inoue |
Organization
Aichi Medical University
Division name
Department of Gastroenterology
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561623311
Homepage URL
tinoue-tag@umin.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
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
Aichi Medical University
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
Tel
0561623311
kanrika@aichi-med-u.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
| 2025 | Year | 03 | Month | 09 | 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
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective evaluation of minimal endoscopic sphincterotomy with papillary balloon dilation using a novel sphincterotome and balloon catheter in balloon enteroscopy-assisted ERCP
Management information
Registered date
| 2025 | Year | 03 | Month | 09 | Day |
Last modified on
| 2025 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065436
