UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057100 |
|---|---|
| Receipt number | R000065062 |
| Scientific Title | Prospective Feasibility Study on Vision-controlled Cannulation with Ultra-thin Cholangioscope through Naive Duodenal Papilla |
| Date of disclosure of the study information | 2025/02/20 |
| Last modified on | 2025/02/21 08:41:08 |
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Basic information
Public title
Prospective Feasibility Study on Vision-controlled Cannulation with Ultra-thin Cholangioscope through Naive Duodenal Papilla
Acronym
Prospective Feasibility Study on Vision-controlled Cannulation with Ultra-thin Cholangioscope through Naive Duodenal Papilla
Scientific Title
Prospective Feasibility Study on Vision-controlled Cannulation with Ultra-thin Cholangioscope through Naive Duodenal Papilla
Scientific Title:Acronym
Prospective Feasibility Study on Vision-controlled Cannulation with Ultra-thin Cholangioscope through Naive Duodenal Papilla
Region
| Japan |
Condition
Condition
Biliary tract diseases requiring ERCP
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of ultrathin cholangioscope-assisted bile duct cannulation in cases of naive papilla.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of bile duct cannulation within 10 minutes
Key secondary outcomes
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
ERCP
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a. Patients requiring ERCP for the biliary system based on imaging and blood test findings.
b. Patients with an untreated duodenal papilla, without prior sphincterotomy, papillectomy, or biliary stenting.
c. Patients needing or likely to need a cholangioscope for bile duct stone treatment, biliary stricture evaluation, or cystic duct cannulation.
d. Patients who provided written informed consent, personally or through a legal representative.
Key exclusion criteria
a. Patients unable to undergo endoscopic treatment due to general condition, jaw, oral, or gastrointestinal issues.
b. Patients with ASA classification class 4 or higher (severe systemic disease posing a life threat) or severe comorbidities such as congestive heart failure, severe coronary insufficiency, recent myocardial infarction (within 3 months), renal failure, liver failure, bleeding peptic ulcer, paralytic ileus, bowel obstruction, or uncontrolled diabetes.
c. Patients with a duodenal papilla entirely located within a periampullary diverticulum.
d. Patients suspected of having a duodenal papillary tumor.
e. Patients in whom access to the duodenal papilla is impossible.
f. Patients with apparent invasion to the duodenal papilla by malignant tumors of the pancreatic head or surrounding area.
g. Patients with surgically reconstructed upper gastrointestinal anatomy, excluding Billroth I.
h. Patients who have previously undergone ERCP with endoscopic sphincterotomy or papillectomy.
i. Patients with a duodenal papilla that has clearly separate openings for the bile duct and pancreatic duct.
j. Patients with impacted duodenal papillary stones where part of the stone is visible at the papillary opening.
k. Patients with a biliary stent in place after a prior ERCP (including inside plastic stents).
l. Patients with a history of severe allergic reactions to biliary contrast agents.
m. Pregnant patients or those with a possible pregnancy.
n. Patients deemed unsuitable for study participation by the attending physician or affiliated department, group, or institution.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kusunose |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
9830824
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai, Miyagi, Japan
TEL
0222521111
hkusu@openhp.or.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kusunose |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
9830824
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai, Miyagi, Japan
TEL
0222521111
Homepage URL
hkusu@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
Funding Source
Organization
Sendai City Medical Center
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 Sendai City Medical Center
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai, Miyagi, Japan
Tel
0222521111
hkusu@openhp.or.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 | 02 | Month | 20 | 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 | 02 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2028 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 20 | Day |
Last modified on
| 2025 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065062
