UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051362 |
|---|---|
| Receipt number | R000058578 |
| Scientific Title | Multicenter prospective observational study of asymptomatic choledocholithiasis |
| Date of disclosure of the study information | 2023/06/16 |
| Last modified on | 2023/12/21 10:53:22 |
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Basic information
Public title
Multicenter prospective observational study of asymptomatic choledocholithiasis
Acronym
Multicenter prospective observational study of asymptomatic choledocholithiasis
Scientific Title
Multicenter prospective observational study of asymptomatic choledocholithiasis
Scientific Title:Acronym
Multicenter prospective observational study of asymptomatic choledocholithiasis
Region
| Japan |
Condition
Condition
Choledocholithiasis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the efficacy of endoscopic treatment of asymptomatic common bile duct stones and the natural history of asymptomatic stones in a multicenter setting. The results of this study may contribute to a change in treatment strategy for asymptomatic common bile duct stones. It will also provide some insight into the natural history of common bile duct stones, which is still unknown.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Event-free survival rate and its comparison by stone size
Key secondary outcomes
Biliary Complication Rate
ERCP complication rate
Overall biliary complication free survival rate
Number of days in hospital
Spontaneous passage rate of common bile duct stones into the duodenum
ERCP success rate
Recurrence rate of common bile duct stones
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with choledocholithiasis by CT, MRI (including MRCP), or EUS imaging
2) Patients who meet the criteria of asymptomatic (not meeting T-Bil is 2 mg/dL or greater or AST, ALT, gammaGTP, ALP is greater than 1.5*STD, and no subjective symptoms)
3) Patients with naive papillae (no history of papillotomy or plasty)
4) Patients aged 20 years or older at the time of informed consent, regardless of gender
5) Patients expected to live longer than 5 years
6) Patients who have given verbal or written consent to participate in the research
Key exclusion criteria
1) Patients who did not consent to participate in this study
2) Patients who cannot undergo endoscopic treatment due to general condition, jaw/oral cavity/digestive tract condition
3) American Society of Anesthesiologists Preoperative Status Classification (ASA Classification) class 4 (life-threatening severe systemic disease) or worse general condition or serious complications (severe congestive heart failure, severe coronary insufficiency , myocardial infarction within 3 months, renal failure, liver failure, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction, poorly controlled diabetes mellitus, etc.)
4) Post-upper gastrointestinal tract reconstruction other than Billroth-I reconstruction (specifically, patients post-Billroth-II and Roux-en-Y reconstruction are excluded)
5) Patients after duodenal papillary resection, papillary papilloplasty, or surgical cholangiodigestive anastomosis
6) Patients with primary sclerosing cholangitis (PSC), IgG4-related cholangitis, or primary biliary cholangitis (PBC)
7) Patients who are pregnant or may be pregnant
8) Patients who are considered impossible to follow up at research participating facilities or related facilities or facilities with which close contact can be made
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | |
| Last name | Iwasaki |
Organization
Keio University
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
(03)3353-1211
e-iwa@keio.jp
Public contact
Name of contact person
| 1st name | Atsuto |
| Middle name | |
| Last name | Kayashima |
Organization
Keio University
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
(03)3353-1211
Homepage URL
kayashima@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical Center
Yokohama Municipal Hospital
Saiseikai Central Hospital
Tokyo Dental College Ichikawa General Hospital
Saitama Medical Center
Saitama City Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3790
med-rinri-jimu@adst.keio.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
| 2023 | Year | 06 | Month | 16 | 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
| 2023 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient background (sex, age, date of birth, performance status, comorbidities, medical history, antithrombotic drug administration and withdrawal, heparinization, gallbladder status, gastric status, common bile duct diameter, calculus diameter, number of stones), details of ERCP treatment (number of examinations, EPBD, EST, EML, biliary stent, nasobiliary tube, cannulation method, pancreatography, pancreatic duct stent, precut, years of operator experience, IDUS, examination time, cannulation time, NSAIDs suppositories), presence/absence and date of occurrence of ERCP complications and biliary complications, severity, presence/absence of death, results of follow-up imaging tests (US, CT, MR, EUS, etc.), if cholecystectomy was performed at a later date will also collect for that date.
Management information
Registered date
| 2023 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058578
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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