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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000042767 |
Receipt No. | 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 | 2021/01/18 |
Basic information | ||
Public title | Endoscopic ultrasound-guided choledochoduodenostomy without fistula dilation for unresectable malignant distal biliary obstruction: a phase 2 prospective trial | |
Acronym | Endoscopic ultrasound-guided choledochoduodenostomy without fistula dilation for unresectable malignant distal biliary obstruction: a phase 2 prospective trial | |
Scientific Title | Endoscopic ultrasound-guided choledochoduodenostomy without fistula dilation for unresectable malignant distal biliary obstruction: a phase 2 prospective trial | |
Scientific Title:Acronym | Endoscopic ultrasound-guided choledochoduodenostomy without fistula dilation for unresectable malignant distal biliary obstruction: a phase 2 prospective trial | |
Region |
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Condition | ||
Condition | unresectable malignant distal biliary obstruction | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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Key exclusion criteria | 1) Judgement unsuitableness by the doctor.
2) Acute cholangitis with moderate or severe in the severity classification. |
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Target sample size | 25 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | National Cancer Center Hospital |
Institute | |
Department |
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 |
chuo-rinrishinsa-sg@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 |
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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 | Preinitiation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048815 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |