UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024508 |
|---|---|
| Receipt number | R000025836 |
| Scientific Title | High and normal negative pressure for endoscopic ultrasound-guided fine-needle aspiration using the 20-gauge side-port fine-needle aspiration needle in patients with pancreatic solid masses: A multicenter prospective randomized controlled study |
| Date of disclosure of the study information | 2016/10/20 |
| Last modified on | 2019/07/26 20:26:12 |
* 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
High and normal negative pressure for endoscopic ultrasound-guided fine-needle aspiration using the 20-gauge side-port fine-needle aspiration needle in patients with pancreatic solid masses: A multicenter prospective randomized controlled study
Acronym
High and normal negative pressure for EUS-FNA using the 20-gauge side-port fine-needle in pancreatic solid masses: A multicenter prospective randomized controlled study
Scientific Title
High and normal negative pressure for endoscopic ultrasound-guided fine-needle aspiration using the 20-gauge side-port fine-needle aspiration needle in patients with pancreatic solid masses: A multicenter prospective randomized controlled study
Scientific Title:Acronym
High and normal negative pressure for EUS-FNA using the 20-gauge side-port fine-needle in pancreatic solid masses: A multicenter prospective randomized controlled study
Region
| Japan |
Condition
Condition
pancreatic solid mass
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of EUS-FNA on pancreatic solid masses using 20-gauge needles with side-port and high negative pressure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acquisition rate of tissue sample adequate for histological diagnosis
Key secondary outcomes
Acquisition rate of white tissue sample, accuracy of pathological diagnosis, size of the sample, adequacy for immunohistochemistry, quality of the sample, adequacy for cytologic diagnosis, and adverse events regarding puncturing site.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Negative pressure for EUS-FNA (10mL)
Interventions/Control_2
Negative pressure for EUS-FNA (50mL)
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) Diagnosed as pancreatic solid mass
2) Mass size of larger than 20mm
3) Age older than 20
4)Informed consent provided the patient him/herself
Key exclusion criteria
1) Case of Performance Status 4.
2) Case with severe comorbidity; American Society of Anesthesiologists (ASA) Grade 3-5
3) Can not stop anti-coagulation or anti-platelet agents.
4) Pregnant or suspicious for pregnancy.
5) Difficulty with endoscopic approach due to post operative state.
6) Case with pathologically confirmation.
7) Gastrointestinal obstruction.
8) Platelet count less than 50,000/mm3
9) PT-INR more than 2.0
10) Those inadequate for endoscopy.
11) Those judged inappropriate by the doctors in charge.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kawakami |
Organization
University of Miyazaki
Division name
Department of Gastroenterology and Hepatology
Zip code
889-1692
Address
5200 Kihara, Kiyotake-cho, Miyazaki city, Miyazaki
TEL
0985-85-9797
hiropon@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Kubota |
Organization
University of Miyazaki
Division name
Department of Gastroenterology and Hepatology
Zip code
889-1692
Address
5200 Kihara, Kiyotake-cho, Miyazaki city, Miyazaki
TEL
0985-85-9797
Homepage URL
y_kubota@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
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
Clinical Research Support Center, University of Miyazaki
Address
5200 Kihara, Kiyotake, Miyazaki city, Miyazaki
Tel
0985-85-1510
rinken@med.miyazaki-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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 20 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 20 | Day |
Last modified on
| 2019 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025836
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
