UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048276 |
|---|---|
| Receipt number | R000055014 |
| Scientific Title | Safety and feasibility of fistulotomy as primary biliary cannulation in endoscopic retrograde cholangiopancreatography |
| Date of disclosure of the study information | 2022/07/05 |
| Last modified on | 2025/07/07 22:10:38 |
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Basic information
Public title
Safety and feasibility of fistulotomy as primary biliary cannulation in endoscopic retrograde cholangiopancreatography
Acronym
Primary fistulotomy study
Scientific Title
Safety and feasibility of fistulotomy as primary biliary cannulation in endoscopic retrograde cholangiopancreatography
Scientific Title:Acronym
Primary fistulotomy study
Region
| Japan |
Condition
Condition
biliary duct disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate a safety and feasibility of primary fistulotomy in ERCP.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of post-ERCP pancreatitis
Key secondary outcomes
Incidence of other complications related to fistulotomy, such as bleeding, cholangitis and cholecystitis, and efficacy of this procedure, such as success rate and time of biliary cannulation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Fistulotomy
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. over 20 years of age
2. Patients who need biliary cannulation in ERCP for biliary disease
Key exclusion criteria
1. Patients with previous sphincterotomy
2. Patients requiring a pancreatogram
3. Patients with prior gastric surgery such as Billroth II and Roux-en Y reconstruction
4. Patients with duodenal stenosis
5. Patients who were deemed unsuitable for participating in this study due to their general condition
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Hara |
Organization
Aichi Cancer Center
Division name
Gastroenterology
Zip code
4648681
Address
1-1, kanokoden, chikusa-ku,Nagoya
TEL
052-762-611
khara@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Okuno |
Organization
Aichi Cancer Center
Division name
Gastroenterology
Zip code
4648681
Address
1-1, kanokoden, chikusa-ku,Nagoya
TEL
052-762-611
Homepage URL
nokuno@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center
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 Cancer Center
Address
1-1, kanokoden, chikusa-ku,Nagoya
Tel
0527626111
irb@aichi-cc.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
| 2022 | Year | 07 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 05 | Day |
Last modified on
| 2025 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055014
