UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046365 |
|---|---|
| Receipt number | R000052906 |
| Scientific Title | A Multicenter Randomized Controlled Trial to Investigate the Efficacy of follow-up for Asymptomatic Common Bile Duct Stones 4mm or less |
| Date of disclosure of the study information | 2021/12/13 |
| Last modified on | 2023/06/14 17:58:32 |
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Basic information
Public title
A Multicenter Randomized Controlled Trial to Investigate the Efficacy of follow-up for Asymptomatic Common Bile Duct Stones 4mm or less
Acronym
SMALL study
Scientific Title
A Multicenter Randomized Controlled Trial to Investigate the Efficacy of follow-up for Asymptomatic Common Bile Duct Stones 4mm or less
Scientific Title:Acronym
SMALL study
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 the this study is to evaluate the efficacy of not performing ERCP for stone removal treatment of asymptomatic common bile duct stones.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall event-free survival
Key secondary outcomes
Incidence rate of biliary complications
Incidence rate of ERCP complications
Overall biliary complication-free survival rate
Hospitalization days
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Follow-up without ERCP treatment.
Interventions/Control_2
Follow-up with ERCP treatment.
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 by imaging diagnosis of CT scan, MRI (including MRCP) scan, or EUS scan
2) Patients who meet the criteria for asymptomatic
3) Patients with a stone diameter of 4 mm or less (any test modality or number of stones, rounded to the nearest whole number)
4) Patients with naive vater papilla (no history of ERCP)
5) Patients aged 20 years or older, regardless of gender
6) Patients who are expected to survive for at least 5 years
7) Patients who have given their written consent to participate in the study
Key exclusion criteria
1) Patients who do not agree to participate in this study
2) Patients who cannot undergo endoscopic treatment due to their general condition, jaw, oral, or gastrointestinal condition
3) Patients who are in poor general condition or have serious complications with American Society of Anesthesiologists (ASA) class 4 or higher
4) Patients with conditions after upper gastrointestinal reconstruction other than Billroth-I reconstruction
5) Patients after duodenal papillectomy, papilloplasty, or surgical bile duct gastrointestinal anastomosis
6) patients with primary sclerosing cholangitis (PSC), IgG4-related cholangitis, or primary biliary cholangitis (PBC)
7) Patients with a history of allergy to biliary contrast agent or severe allergy to angiographic contrast agent
8) Patients who, if assigned to group B, will not be able to undergo ERCP within 1 month
9) Patients who are pregnant or may become pregnant
10) Patients for whom follow-up observation is considered impossible
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | |
| Last name | Iwasaki |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3790
e-iwa@keio.jp
Public contact
Name of contact person
| 1st name | Atsuto |
| Middle name | |
| Last name | Kayashima |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3790
Homepage URL
kayashima@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
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
National Hospital Organization Tokyo Medical Center
Yokohama Municipal Citizen's 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
| 2021 | Year | 12 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 12 | Month | 13 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052906
