UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014410 |
|---|---|
| Receipt number | R000015871 |
| Scientific Title | Usefulness of Forward-Viewing Endoscopic Ultrasound Scope for the Gastrointestinal tract submucosal tumors less than 15mm. |
| Date of disclosure of the study information | 2014/06/28 |
| Last modified on | 2015/07/31 12:12:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Usefulness of Forward-Viewing Endoscopic Ultrasound Scope for the Gastrointestinal tract submucosal tumors less than 15mm.
Acronym
Usefulness of Forward-Viewing Endoscopic Ultrasound Scope for the Gastrointestinal tract submucosal tumors less than 15mm.
Scientific Title
Usefulness of Forward-Viewing Endoscopic Ultrasound Scope for the Gastrointestinal tract submucosal tumors less than 15mm.
Scientific Title:Acronym
Usefulness of Forward-Viewing Endoscopic Ultrasound Scope for the Gastrointestinal tract submucosal tumors less than 15mm.
Region
| Japan |
Condition
Condition
gastrointestinal submucosal lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Previous report demonstrated endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) for gastrointestinal submucosal lesion (SML) is feasible and safe with high diagnostic yield. On the other hand, since it is difficult to perform EUS-FNA for small SML especially less than 15mm, almost small SMLs are observed without EUS-FNA. However, because SMLs include malignant lesions even though a tumor is small, it is desirable to perform EUS-FNA when possible. The aim of this study is to evaluate feasibility and safety of EUS-FNA using forward-viewing echoendoscope attached with a cap device to the tip of scope for the small SML.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of sampling, accuracy, and complication
Key secondary outcomes
Kind of used device
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
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.A patient having SMT less than 15mm.
2.When the whole lesion can be observed with the forward-viewing echoendoscope, and a puncture route is secured, and can puncture it safely.
3.When EUS-FNA brings the information that is important to the treatment choice of the patient.
4.After having received enough explanation about inspection,the patient that understood enough, and a document agreement was provided.
5.Performance status does not have the limit in particular.
Key exclusion criteria
1.Blood disorder (hemoglobin <7.0 g/dL or platelet <100000/uL)
2.Renal disease (blood BUN> 25 mg/dL or blood creatinine> 2.0 mg/dL)
3.Liver disease (Child Pugh score> 6)
4.Extension of the solidification time(for warfarin potassium internal use or cirrhosis,Under 70 years old PT-INR> 3.0, 70 years old or more PT-INR>2.6)
5.Case to have serious complications to other organs.More than the three of the ASA classification(the dialysis patient is excluded)
6.Case not to be provided of Informed consent
7.In addition, the patient who judged the examination medical attendant to be inappropriate as a subject
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akane Yamabe |
Organization
Fukushima Medical University Aizu Medical Center
Division name
Gastroenterology
Zip code
Address
21-2, Maeda, Tanisawa, Kawahigashi., Aizuwakamatsu, Japan
TEL
0242-75-2100
akaneko@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akane Yamabe |
Organization
Fukushima Medical University Aizu Medical Center
Division name
Gastroenterology
Zip code
Address
21-2, Maeda, Tanisawa, Kawahigashi., Aizuwakamatsu, Japan
TEL
0242-75-2100
Homepage URL
akaneko@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University Aizu Medical Center
Institute
Department
Personal name
Funding Source
Organization
organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 06 | Month | 28 | 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
Suspended
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Without intervention, be the observational studies using samples.
A study period is from March, 2014 to July, 2014.
Management information
Registered date
| 2014 | Year | 06 | Month | 28 | Day |
Last modified on
| 2015 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015871
