UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042767 |
|---|---|
| Receipt number | R000048815 |
| Scientific Title | Endoscopic ultrasound-guided choledochoduodenostomy without fistula dilation for unresectable malignant distal biliary obstruction: a phase 2 prospective trial |
| Date of disclosure of the study information | 2021/01/14 |
| Last modified on | 2022/12/18 11:05:02 |
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Basic information
Public title
Endoscopic ultrasound-guided choledochoduodenostomy without fistula dilation for unresectable malignant distal biliary obstruction: a phase 2 prospective trial
Acronym
CYCLONE
Scientific Title
Endoscopic ultrasound-guided choledochoduodenostomy without fistula dilation for unresectable malignant distal biliary obstruction: a phase 2 prospective trial
Scientific Title:Acronym
CYCLONE
Region
| Japan |
Condition
Condition
unresectable malignant distal biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of EUS-CDS without fistula dilation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success
Key secondary outcomes
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
EUS-CDS without fistula dilation
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Unresectable malignant distal biliary obstruction.
2) Indication for EUS-CDS procedure.
3) One of the following conditions (1), (2), or (3) is met. (1) Total bilirubin >1.5 mg/dL, (2) AST >100 U/L, or (3) ALT >100 U/L.
4) No parenchymal jaundice.
5) No bleeding tendency (platelets >= 50,000, prothrombin (PT) activity time >= 50%).
6) Hemoglobin level >= 8g/dL.
7) Performance status (ECOG): 0, 1, 2.
8) Age: 20 years or older.
9) Patient's written consent for participation in the study.
Key exclusion criteria
1) Judgement unsuitableness by the doctor.
2) Acute cholangitis with moderate or severe in the severity classification.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Hijioka |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology Division
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
TEL
03-3542-2511
shijioka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Takehiko |
| Middle name | |
| Last name | Koga |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology Division
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
takehikoga@gmail.com
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital
Address
5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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 | 01 | 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
| 2021 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 14 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 14 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 14 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 16 | Day |
Last modified on
| 2022 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048815
