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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016815 |
Receipt No. | R000019523 |
Scientific Title | Magnifying endoscopy with crystal violet staining in the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma |
Date of disclosure of the study information | 2015/03/17 |
Last modified on | 2019/02/11 |
Basic information | ||
Public title | Magnifying endoscopy with crystal violet staining in the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma | |
Acronym | Magnifying endoscopy with crystal violet staining in the differential diagnosis of duodenal adenoma/carcinoma | |
Scientific Title | Magnifying endoscopy with crystal violet staining in the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma | |
Scientific Title:Acronym | Magnifying endoscopy with crystal violet staining in the differential diagnosis of duodenal adenoma/carcinoma | |
Region |
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Condition | ||
Condition | Sporadic nonampullary duodenal adenoma/carcinoma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To reveal the efficacy of magnifying endoscopy with crystal violet staining in the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | The accuracy of the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma by magnifying endoscopy with crystal violet staining (low-grade dysplasia or high-grade dysplasia/carcinoma) |
Key secondary outcomes | The sensitivity, specificity, positive predictive value, and negative predictive value of the differential diagnosis of sporadic nonampullary duodenal adenoma/carcinoma by magnifying endoscopy with crystal violet staining (low-grade dysplasia or high-grade dysplasia/carcinoma) and the relationship between these and patients background or lesions information |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
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Eligibility | ||||
Age-lower limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients who underwent endoscopic resection of nonampurally duodenal lesions and confirmed diagnosis of adenoma/carcinoma with pathological diagnosis | |||
Key exclusion criteria | Patients with polyposis syndrome or evaluated incompetent by doctors in attendance | |||
Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Chiba University Hospital | ||||||
Division name | Gastroenterology | ||||||
Zip code | |||||||
Address | Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University (K1), 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan | ||||||
TEL | 043-226-2083 | ||||||
araim-cib@umin.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Chiba University Hospital | ||||||
Division name | Gastroenterology | ||||||
Zip code | |||||||
Address | 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan | ||||||
TEL | 043-226-2083 | ||||||
Homepage URL | |||||||
maruoka-cib@umin.ac.jp |
Sponsor | |
Institute | Chiba University |
Institute | |
Department |
Funding Source | |
Organization | Chiba University |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | https://journals.sagepub.com/doi/pdf/10.1177/2050640614548980 |
Number of participants that the trial has enrolled | |
Results | CV-ME does not have additional diagnostic value compared with NBI-ME in the diagnosis of sporadic nonampullary duodenal adenoma/carcinoma. |
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 | Completed | ||||||
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Other | |
Other related information | We perform a retrospective study for magnifying endoscopy with crystal violet staining in the differential diagnosis of sporadic nonampullary duodenal low-grade dysplasia or high-grade dysplasia/intramucosal carcinoma. |
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=R000019523 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |