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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000031601 |
Receipt No. | R000036026 |
Scientific Title | Exploratory survey of the safety and efficacy of endoscopic radiofrequency ablation for malignant biliary stricture |
Date of disclosure of the study information | 2018/03/12 |
Last modified on | 2019/12/02 |
Basic information | ||
Public title | Exploratory survey of the safety and efficacy of endoscopic radiofrequency ablation for malignant biliary stricture | |
Acronym | Endoscopic radiofrequency ablation for malignant biliary stricture | |
Scientific Title | Exploratory survey of the safety and efficacy of endoscopic radiofrequency ablation for malignant biliary stricture | |
Scientific Title:Acronym | Endoscopic radiofrequency ablation for malignant biliary stricture | |
Region |
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Condition | ||
Condition | Malignant biliary stricture | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Exploratory survey of the safety and efficucy of endoscopic radiofrequency ablation for malignant biliary stricture |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Serious adverse event incidence |
Key secondary outcomes | Procedure completion rate Evaluation of malignant biliary stricture diameter and stenosis length in retrograde cholangiography (before and after treatment) Evaluation of cauterization range using Dynamic CT Biliary stent patent term Overall survival Adverse event incidence (post-bleeding rate, cholangitis incidence rate, pancreatitis incidence rate, fever incidence rate, abdominal pain incidence rate) |
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 | Perform endoscopic radiofrequency ablation therapy for malignant biliary stricture patients requiring biliary duct drainage before biliary stent placement | |
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) Patients with biliary stricture due to malignant disease and requiring biliary duct drainage 2) Patients with malignancy diagnosed pathologically or radiologically / endoscopically 3) Patients who are surgically inoperable or are not surgically applied 4) Patients who are over 20 years of age at the time of consent acquisition 5) Patients who do not take anticoagulants, antiplatelet drugs or patients who can be discontinued before the study treatment 6) After receiving sufficient explanation for the participation of this study, patients who gained written consent by the patient's free will with sufficient understanding |
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Key exclusion criteria | 1) Patients with malignant biliary stricture due to lymph node metastasis 2) Patient with pacemaker or defibrillator inserted 3) Patients who are unlikely to have a prognosis for 1 month 4) Patients with performance status 2 or higher 5) Patients who can not control bleeding tendency (PTINR 1.5 or more, platelet number 50,000 or less). 6) Patients with duodenal stenosis, obstruction that may affect biliary excretion 7) Patients who are pregnant, have a possibility of pregnancy, are within 28 days after birth, or who are breastfeeding 8) Patients with history of upper gastrointestinal surgical resection 9) Patients who have impaired renal function and can not perform contrast CT 10) Patients in which a bile duct metal stent has already been placed |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Graduate School of Medicine, Chiba University | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | |||||||
Address | 1-8-1 Inohana, Chuo-ku, Chiba, Japan | ||||||
TEL | +81-43-226-2083 | ||||||
kato.naoya@chiba-u.jp |
Public contact | |||||||
Name of contact person |
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Organization | Graduate School of Medicine, Chiba University | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | |||||||
Address | 1-8-1 Inohana, Chuo-ku, Chiba, Japan | ||||||
TEL | +81-43-226-2083 | ||||||
Homepage URL | |||||||
sugiharu_food@yahoo.co.jp |
Sponsor | |
Institute | Graduate School of Medicine, Chiba University |
Institute | |
Department |
Funding Source | |
Organization | SHIONOGI & CO., LTD. Boston Scientific Japan Co., Ltd. Daiichi Sankyo Co., Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
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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 | 千葉大学医学部附属病院(千葉県)Chiba University Hospital |
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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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=R000036026 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |