UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000006259 |
| Receipt No. | R000007407 |
| Scientific Title | Efficacy of contrast-enhanced intraoperative ultrasonic cholangiography using sonazoid in hepatobiliary disease |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2019/05/20 (Ver. 14) |
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| Basic information | ||
| Public title | Efficacy of contrast-enhanced intraoperative ultrasonic cholangiography using sonazoid in hepatobiliary disease | |
| Acronym | intraoperative ultrasonic cholangiography using sonazoid | |
| Scientific Title | Efficacy of contrast-enhanced intraoperative ultrasonic cholangiography using sonazoid in hepatobiliary disease | |
| Scientific Title:Acronym | intraoperative ultrasonic cholangiography using sonazoid | |
| Region |
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| Condition | ||
| Condition | hepatobiliary disease or donor in living donor liver transplantation | |
| Classification by specialty |
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| Classification by malignancy | Malignancy | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | To assess the efficacy of inraoperaive ultrasonography with cholangiography using sonazoid. |
| Basic objectives2 | Safety,Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | Exploratory |
| Trial characteristics_2 | Pragmatic |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | the ability to visualize a biliary road map intraoperatively |
| 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 | Diagnosis | ||
| Type of intervention |
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| Interventions/Control_1 | intraoperative ultrasonic cholangiography using sonazoid | ||
| 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)Patient who undergo hepatectomy with cholecystectomy
2)Patient who underwent abdominal enhanced ultrasonography using sonazoid intravenously and didn't have any allergy 3)Patient who write informed consent |
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| Key exclusion criteria | 1)Allergy for sonazoid
2)Allergy for egg and dairy product 3)Patient who have cholecystitis or cholangitis 4)Patients seems inadequate for this study by investigaors |
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| Target sample size | 100 | |||
| Research contact person | |||||||
| Last name of lead principal investigator |
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| Organization | Kobe University Graduate School of Medicine | ||||||
| Division name | Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery | ||||||
| Zip code | 650-0017 | ||||||
| Address | 7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe-City, Hyogo | ||||||
| TEL | 0783826302 | ||||||
| fukumoto@med.kobe-u.ac.jp | |||||||
| Public contact | |||||||
| 1st name of contact person |
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| Organization | Kobe University Graduate School of Medicine | ||||||
| Division name | Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery | ||||||
| Zip code | 650-0017 | ||||||
| Address | 7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe-City, Hyogo | ||||||
| TEL | 0783826302 | ||||||
| Homepage URL | |||||||
| junsuzu@med.kobe-u.ac.jp | |||||||
| Sponsor | |
| Institute | Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine |
| 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 | Kobe University Hospital Clinical & Translational Research Center |
| Address | 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN, 650-0017 |
| Tel | 078-382-6669 |
| chiken@med.kobe-u.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 | 神戸大学医学部附属病院（兵庫県） |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000007407 |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | https://www.journalacs.org/article/S1072-7515(13)01146-0/fulltext | ||||||
| Number of participants that the trial has enrolled | 46 | ||||||
| Results | Bibliography: Contrast-enhanced intraoperative ultrasonic cholangiography for real-time biliary navigation in hepatobiliary surgery.J Am Coll Surg. 2014 Feb;218(2):e43-50. Contrast-enhanced intraoperative ultrasonic cholangiography in living donor hepatectomy.Liver Transpl. 2016 Oct;22(10):1437-42. (https://aasldpubs.onlinelibrary.wiley.com/doi/epdf/10.1002/lt.24519) |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Patients who are scheduled to undergo hepatobiliary surgery against hepatobiliary diseases or donors who are scheduled to undergo living donor hepatectomy for living donor liver transplantation |
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| Participant flow | The participants undergo the operation and have perioperative management in Kobe university hospital. |
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| Adverse events | none |
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| Outcome measures | Detectability of bile ducts with contrast-enhanced intraoperative ultrasonic cholangiography |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Date of closure to data entry | |||||||
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| 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/icdr_e/ctr_view.cgi?recptno=R000007407 |
