UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062881 |
|---|---|
| Receipt number | R000071804 |
| Scientific Title | A multicenter retrospective study on the prevention of impaired bile outflow by endoscopic biliary drainage following complete removal of common bile duct stones |
| Date of disclosure of the study information | 2026/09/12 |
| Last modified on | 2026/09/11 00:45:48 |
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Basic information
Public title
A multicenter retrospective study on the prevention of impaired bile outflow by endoscopic biliary drainage following complete removal of common bile duct stones
Acronym
A multicenter retrospective study on the prevention of impaired bile outflow by endoscopic biliary drainage following complete removal of common bile duct stones
Scientific Title
A multicenter retrospective study on the prevention of impaired bile outflow by endoscopic biliary drainage following complete removal of common bile duct stones
Scientific Title:Acronym
A multicenter retrospective study on the prevention of impaired bile outflow by endoscopic biliary drainage following complete removal of common bile duct stones
Region
| Japan |
Condition
Condition
common bile duct stone, acute cholangitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate patients who underwent endoscopic stone extraction via ERCP for common bile duct stones, focusing on two major objectives:
1. Preventive effect of endoscopic biliary drainage (EBD) immediately after complete stone removal
We will compare patients who received EBD immediately after complete stone removal with those who did not receive EBD, assessing:Patient-related factors,Procedure-related factors,Post-procedural factors.Through these analyses, we aim to clarify the preventive effect of EBD on postoperative biliary outflow obstruction and to compare the medical costs associated with each treatment strategy.
2. Risk factors for post-ERCP cholangitis in patients without EBD
Among patients who did not undergo EBD, we will compare those who developed post-ERCP cholangitis with those who did not to identify risk factors associated with cholangitis after ERCP.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of biliary outflow obstruction and post ERCP cholangitis in patients who underwent complete stone removal for common bile duct stones comparing the EBD group and the non EBD group
The following criteria were used for the definitions.
Biliary outflow obstruction was defined as meeting criterion a.
Post ERCP cholangitis was defined as meeting all of criteria a b and c.
a. Elevation of any hepatobiliary enzyme to a value greater than the upper limit of normal and greater than one point five times the pre ERCP value measured twelve to twenty four hours after ERCP.
b. Persistent elevation of white blood cell count and C reactive protein for twelve to twenty four hours or longer after ERCP accompanied by fever of thirty eight degrees Celsius or higher with other infectious etiologies excluded.
c. New onset or worsening of cholangitis diagnosed by the attending physician based on clinical symptoms requiring additional treatment including conservative management.
Key secondary outcomes
Analysis of factors associated with the development of biliary outflow obstruction and post ERCP cholangitis in the non EBD group
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with asymptomatic or symptomatic common bile duct stones in whom complete stone removal by ERCP was confirmed on fluoroscopic imaging.
Key exclusion criteria
Patients who underwent stone removal for severe acute cholangitis
Patients with a history of gastrointestinal reconstruction other than Billroth one
Patients with percutaneous biliary drainage or gallbladder drainage
Patients with severe comorbidities involving other organs
Patients deemed inappropriate for inclusion by the principal or sub investigator
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | HIROAKI |
| Middle name | |
| Last name | TSUJI |
Organization
Oita Sanai Medical Center
Division name
Department of Gastroenterology
Zip code
8701151
Address
1213,Oaza-ichi,Oita-City,Oita,Japan
TEL
0975411311
akitsuji1989@yahoo.co.jp
Public contact
Name of contact person
| 1st name | HIROAKI |
| Middle name | |
| Last name | TSUJI |
Organization
Oita Sanai Medical Center
Division name
Department of Gastroenterology
Zip code
8701151
Address
1213,Oaza-ichi,Oita-City,Oita,Japan
TEL
0975411311
Homepage URL
akitsuji1989@yahoo.co.jp
Sponsor or person
Institute
Oita Sanai Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self Funding
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
OitaSanai Medical Center
Address
1213
Tel
0975411311
akitsuji1989@yahoo.co.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
大分大学医学部付属病院（大分県）大分県立病院（大分県）アルメイダ病院 (大分県) 大分医療センター（大分県）新別府病院（大分県）大分赤十字病院（大分県）豊後高田中央病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 12 | 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
1916
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
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Population and Case Identification
Each institution will identify patients who underwent ERCP during the study period by reviewing endoscopy databases and medical records using terms related to common bile duct stones and cholangitis. Patients in whom complete removal of common bile duct stones was confirmed by fluoroscopy will be included. They will be classified into those who received endoscopic biliary drainage after stone removal and those who did not. Patient and procedure characteristics will be compared to evaluate whether endoscopic biliary drainage prevents postoperative impairment of biliary outflow.
Data Collection
Patient related factors
Age, sex, major underlying diseases, use of antithrombotic medication, presence of the gallbladder and gallbladder stones, performance status, history of papillary treatment, clinical findings including vital signs, abdominal pain, fever, consciousness, oxygen saturation, jaundice, and ascites. Laboratory tests including blood counts, coagulation tests, and biochemical tests. Presence and severity of cholangitis and imaging findings.
Procedure related factors
Presence of a diverticulum near the papilla, use of precut sphincterotomy, pancreatic duct cannulation, method of papillary treatment, length of incision, diameter of dilation, diameter of the common bile duct, size and number of stones, method of extraction, use of lithotripsy, type of biliary drainage, type of stent, and duration of the procedure.
Post procedural factors
Clinical findings after the procedure, laboratory tests on the following day, presence of impaired biliary outflow, presence and severity of cholangitis after ERCP, treatment of cholangitis, unplanned removal of biliary drainage, presence of cholecystitis, other complications including pancreatitis, bleeding, and perforation, early complications, use of ursodeoxycholic acid, time until oral intake, length of hospital stay, final follow up date, and recurrence of stones or cholangitis.
Management information
Registered date
| 2026 | Year | 09 | Month | 11 | Day |
Last modified on
| 2026 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071804
