UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059020 |
|---|---|
| Receipt number | R000067499 |
| Scientific Title | Development and Validation of a Predictive Scoring System for Bailout Procedures during Laparoscopic Cholecystectomy: A Multicenter Cluster Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/09/07 |
| Last modified on | 2025/09/06 14:12:52 |
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Basic information
Public title
Development and Validation of a Predictive Scoring System for Bailout Surgery in Laparoscopic Cholecystectomy: A Cluster Randomized Controlled Trial
Acronym
ESCAPE-LC Trial
Scientific Title
Development and Validation of a Predictive Scoring System for Bailout Procedures during Laparoscopic Cholecystectomy: A Multicenter Cluster Randomized Controlled Trial
Scientific Title:Acronym
ESCAPE-LC Trial
Region
| Japan |
Condition
Condition
benign gallbladder diseases
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate whether the application of the Bailout Score in the preoperative assessment of laparoscopic cholecystectomy can accurately predict surgical difficulty and the necessity of bailout procedures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bailout rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Presentation of the Bailout Score during preoperative assessment to predict surgical difficulty and the necessity of bailout procedures.
Interventions/Control_2
Standard preoperative assessment without presentation of the Bailout Score.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases of benign gallbladder diseases treated with laparoscopic cholecystectomy between July 1, 2025, and September 30, 2027
Key exclusion criteria
Malignant diseases
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Saiura |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Hepatobiliary-Pancreatic Surgery
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-3813-3111
s.irie.fo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Irie |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Hepatobiliary-Pancreatic Surgery
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-3813-3111
Homepage URL
s.irie.fo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No
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
Institutional Review Board, Juntendo University Hospital
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
Tel
03-3813-3111
hongo-rinri@juntendo.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
| 2025 | Year | 09 | Month | 07 | 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
| 2025 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 09 | Month | 06 | Day |
Last modified on
| 2025 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067499
