UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050327 |
|---|---|
| Receipt number | R000057309 |
| Scientific Title | Prospective study on efficacy of prophylactic gallbladder stent for preventing acute cholecystitis induced after use of metallic stent placement for malignant biliary strictures |
| Date of disclosure of the study information | 2023/02/14 |
| Last modified on | 2023/02/22 19:01:06 |
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Basic information
Public title
Prospective study on efficacy of prophylactic gallbladder stent for preventing acute cholecystitis induced after use of metallic stent placement for malignant biliary strictures
Acronym
Prospective study on efficacy of prophylactic gallbladder stent for preventing acute cholecystitis induced after use of metallic stent placement for malignant biliary strictures
Scientific Title
Prospective study on efficacy of prophylactic gallbladder stent for preventing acute cholecystitis induced after use of metallic stent placement for malignant biliary strictures
Scientific Title:Acronym
Pegasus study
Region
| Japan |
Condition
Condition
malignant biliary strictures, bile duct cancer, pancreatic cancer, cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of prophylactic gallbladder stent for preventing acute cholecystitis induced after use of metallic stent placement for malignant biliary strictures
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of acute cholecystitis at 30 days after treatment
Key secondary outcomes
Technical success rate
Adverse event rate
Risk factors for the development of acute cholecystitis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic transpapillary gallbladder drainage
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who undergo endoscopic biliary drainage for malignant biliary strictures
obtaining written informed consent
Key exclusion criteria
bleeding tendency
poor general condition
Patients considering radiation therapy, etc.
After placement of an unremovable biliary stent
Benign biliary strictures
After cholecystectomy
pregnancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fumisato |
| Middle name | |
| Last name | Kozakai |
Organization
Sendai City Medical Center
Division name
Department of gastroenterology
Zip code
983-0824
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL
0222521111
kozakai5656@openhp.or.jp
Public contact
Name of contact person
| 1st name | Fumisato |
| Middle name | |
| Last name | Kozakai |
Organization
Sendai City Medical Center
Division name
Department of gastroenterology
Zip code
983-0824
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL
0222521111
Homepage URL
kozakai5656@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the institutional review board of Sendai City Medical Center
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai, Japan
Tel
022-252-1111
k.tochikubo@openhp.or.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 | 02 | Month | 14 | 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
| 2023 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 05 | 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
| 2023 | Year | 02 | Month | 13 | Day |
Last modified on
| 2023 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057309
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
