UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063170 |
|---|---|
| Receipt number | R000072299 |
| Scientific Title | Impact of Green Endoscopy Practices on the Number of Devices Used During Endoscopic Retrograde Cholangiopancreatography: A Prospective Interventional Study |
| Date of disclosure of the study information | 2026/10/04 |
| Last modified on | 2026/10/04 16:51:31 |
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Basic information
Public title
A Study Evaluating Green Endoscopy Practices to Reduce Device Use During ERCP
Acronym
Green Endoscopy in ERCP: A Study of Device Use Reduction
Scientific Title
Impact of Green Endoscopy Practices on the Number of Devices Used During Endoscopic Retrograde Cholangiopancreatography: A Prospective Interventional Study
Scientific Title:Acronym
Green Endoscopy and Device Use in ERCP: A Prospective Interventional Study
Region
| Japan |
Condition
Condition
Common bile duct stones and common bile duct stone-induced cholangitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to verify whether the number of devices used during ERCP for common bile duct stones and associated cholangitis can be reduced-while maintaining treatment outcomes-by implementing interventions aimed at minimizing device usage from the perspective of Green Endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total number of devices used during the same hospital admission
Count the total number of devices used across all ERCP sessions performed during the same hospital admission.
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Endoscopists performing ERCP receive an educational session covering Green Endoscopy principles, the environmental impact of endoscopic practice, and practical strategies to reduce device use. Following the session, the following strategies are implemented, when clinically appropriate, during all ERCP sessions within the same hospitalization for common bile duct stones or associated cholangitis:
Using the cannulation function of a sphincterotome to reduce the use of separate cannulation catheters.
Using integrated devices for endoscopic sphincterotomy and papillary balloon dilation, including large-balloon dilation.
Using either a stone extraction basket or an extraction balloon alone whenever feasible.
Completing treatment with the initially selected device whenever feasible.
Planning device selection through preprocedure case discussions.
Final device selection remains at the discretion of each endoscopist, with treatment safety and efficacy taking priority. Additional devices or device changes are permitted as clinically necessary. Device use, treatment outcomes, and safety are compared with historical controls treated under usual practice before implementation.
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 diagnosed with common bile duct stones or cholangitis due to common bile duct stones.
2. Patients for whom stone removal by ERCP is indicated.
3. Patients aged 20 years or older.
Key exclusion criteria
1. Patients with surgically altered gastrointestinal anatomy other than Billroth I reconstruction.
2. Patients whose primary disease is intrahepatic bile duct stones.
3. Patients with concomitant malignant biliary strictures.
4. Patients requiring a percutaneous transhepatic approach.
5. Patients from whom written informed consent for study participation cannot be obtained (post-intervention group only).
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kiyoyuki |
| Middle name | |
| Last name | Kobayashi |
Organization
HITO Medical Center
Division name
Departmanet of Gastroenterology and Hepatology
Zip code
799-0121
Address
788-1, Kamibun-cho, Shikokuchuo-city, Ehime, Japan
TEL
0896-58-2222
kobayashi.kiyoyuki@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiyoyuki |
| Middle name | |
| Last name | Kobayashi |
Organization
HITO Medical Center
Division name
Departmanet of Gastroenterology and Hepatology
Zip code
799-0121
Address
788-1, Kamibun-cho, Shikokuchuo-city, Ehime, Japan
TEL
0896-58-2222
Homepage URL
kobayashi.kiyoyuki@kagawa-u.ac.jp
Sponsor or person
Institute
HITO Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
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
Ethics Committee of HITO Hospital
Address
788-1 Kamibun-cho, Shikokuchuo, Ehime 799-0121, Japan
Tel
0896-58-2222
kobayashi.kiyoyuki@kagawa-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
| 2026 | Year | 10 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 04 | Day |
Last modified on
| 2026 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072299
