UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063086 |
|---|---|
| Receipt number | R000069961 |
| Scientific Title | A multicenter observational study to evaluate the incidence of pancreatitis and its associated factors following the double-guidewire technique during biliary cannulation in ERCP |
| Date of disclosure of the study information | 2026/09/28 |
| Last modified on | 2026/09/28 20:50:54 |
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Basic information
Public title
A multicenter observational study to evaluate the incidence of pancreatitis and its associated factors following the double-guidewire technique during biliary cannulation in ERCP
Acronym
DGT study
Scientific Title
A multicenter observational study to evaluate the incidence of pancreatitis and its associated factors following the double-guidewire technique during biliary cannulation in ERCP
Scientific Title:Acronym
DGT study
Region
| Japan |
Condition
Condition
[Inclusion Criteria]
i) Patients undergoing ERCP for the first time
ii) Patients in whom the double-guidewire technique (DGT) was used during biliary cannulation
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The double-guidewire technique (DGT), in which a second guidewire is used to attempt biliary cannulation while a guidewire is left in the pancreatic duct, is one of the salvage techniques for difficult biliary cannulation during ERCP. Although DGT has been reported to improve biliary cannulation success in difficult cases, it may also increase the risk of post-ERCP pancreatitis (PEP) because of pancreatic guidewire placement and repeated pancreatic manipulation. However, it remains unclear which components of the DGT procedure are associated with the development or severity of PEP. We therefore conducted a multicenter observational study to investigate the risk factors for PEP in patients undergoing DGT.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of post-ERCP pancreatitis (PEP) and identification of risk factors for PEP among patients undergoing the double-guidewire technique (DGT)
Key secondary outcomes
Identification of risk factors for moderate-to-severe PEP, as well as factors associated with prolonged biliary cannulation time and unsuccessful biliary cannulation among patients undergoing DGT
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Inclusion Criteria]
i) Patients undergoing ERCP for the first time
ii) Patients in whom the double-guidewire technique (DGT) was used during biliary cannulation
Key exclusion criteria
[Exclusion Criteria]
i) Patients with a history of ERCP
Cases in which ERCP had been attempted previously but biliary cannulation was unsuccessful will be regarded as first-time ERCP cases.
ii) Patients undergoing ERCP solely for pancreatic duct-related diseases
iii) Patients with surgically altered anatomy, excluding Billroth I reconstruction
iv) Patients who have undergone prior pancreatic resection
v) Patients with pancreaticobiliary maljunction
vi) Patients judged by the principal investigator or subinvestigators to be inappropriate for inclusion in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Kaneko |
Organization
Iwata City Hospital
Division name
Department of Gastroenterology
Zip code
438-8550
Address
512-3 Okubo, Iwata, Shizuoka 438-8550, Japan
TEL
0538-38-5000
meganerock10@gmail.com
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Kaneko |
Organization
Iwata City Hospital
Division name
Department of Gastroenterology
Zip code
438-8550
Address
512-3 Okubo, Iwata, Shizuoka 438-8550, Japan
TEL
0538-38-5000
Homepage URL
meganerock10@gmail.com
Sponsor or person
Institute
Iwata City Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Aichi Medical University School of Medicine
Address
1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan
Tel
0561-62-3311
tgeki2a@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
25-1250
Org. issuing International ID_1
Institutional Review Board of Aichi Medical University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
愛知医科大学病院（愛知県） 消化器内科（共同代表）
岐阜大学医学部附属病院（岐阜県） 消化器内科
聖隷浜松病院（静岡県） 消化器内科
三重大学医学部附属病院（三重県） 消化器・肝臓内科
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 28 | 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
| 2026 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069961
