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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012169
Receipt No. R000014226
Scientific Title Comparative analysis of the usefulness of endoscopic ultrasound guided fine needle aspiration (EUS-FNA) and mucosal incision assisted biopsy (MIAB) in the diagnosis of gastrointestinal stromal tumors (GIST) of the stomach.
Date of disclosure of the study information 2013/11/05
Last modified on 2018/09/25

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Basic information
Public title Comparative analysis of the usefulness of endoscopic ultrasound guided fine needle aspiration (EUS-FNA) and mucosal incision assisted biopsy (MIAB) in the diagnosis of gastrointestinal stromal tumors (GIST) of the stomach.
Acronym Comparative analysis of the usefulness of EUS-FNA and MIAB in the diagnosis of GIST of the stomach.
Scientific Title Comparative analysis of the usefulness of endoscopic ultrasound guided fine needle aspiration (EUS-FNA) and mucosal incision assisted biopsy (MIAB) in the diagnosis of gastrointestinal stromal tumors (GIST) of the stomach.
Scientific Title:Acronym Comparative analysis of the usefulness of EUS-FNA and MIAB in the diagnosis of GIST of the stomach.
Region
Japan

Condition
Condition gastrointestinal stromal tumor
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to determine which is more suitable diagnostic method for GIST of the stomach, EUS-FNA and MIAB, by comparing tissue extraction rate, diagnostic yield, risk of complication of EUS-FNA and MIAB.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Comparison of successful tissue extraction rates of FNA and MIAB for pathological diagnosis of gastric GIST by H.E and immunohistochemistry staining.
Key secondary outcomes (1) Comparison of the diagnostic yield of EUS-FNA and MIAB.
(2) Comparison of safety of EUS-FNA and MIAB.
(3) Comparison of procedure time and biopsy frequency of EUS-FNA and MIAB

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 EUS-FNA group:
(1) Tissue sampling is performed for patients with suspected gastric GISTs by EUS-FNA.
(2) When tissue samples obtained by EUS-FNA is sufficient for a differential diagnosis of Gastrointestinal mesenchymal tumor, no additional procedure is required.
(3) If not, MIAB is performed to obtain tissue samples further to assess the diagnosis.
Interventions/Control_2 MIAB group:
(1) Tissue sampling is performed for patients with suspected gastric GISTs by MIAB.
(2) When tissue samples obtained by MIAB is sufficient for a differential diagnosis of Gastrointestinal mesenchymal tumor, no additional procedure is required.
(3) If not, EUS-FNA is performed to obtain tissue samples further to assess the diagnosis.
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) The patients who are suspected to have Gastric GIST by EUS
(2) Tumor size ranges between 1 cm and 5 cm
(3) Patients with tumors of extraluminal growth patterns are excluded.
(4) The patients who personally give written informed consent to participate in this study.
Key exclusion criteria (1) Patients who are not candidates for upper gastrointestinal endoscopy including ileus, gastrointestinal perforation, critical respiratory ailment, cardiovascular diseases, etc.
(2) Patients taking antithrombotic treatment
(3) Patients with bleeding tendency
(4) Patients judged by the principal or sub-investigator to be unsuitable for the study
(5) Patients without written informed consent
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Ogawa
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Medicine and Bioregulatory Science
Zip code
Address 3-1-1, Maidasi, Higashi-ku, Fukuoka, 812-8582 Japan
TEL 092-642-5286
Email t.osoegawa@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Osoegawa Takashi
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Endoscopic Diagnostics and Therapeutics
Zip code
Address 3-1-1, Maidasi, Higashi-ku, Fukuoka, 812-8582 Japan
TEL 092-641-1151
Homepage URL
Email t.osoegawa@gmail.com

Sponsor
Institute Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National kyushu medical center
Kyushu rosai hoospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 九州大学病院(福岡県)
九州労災病院(福岡県)
九州医療センター(福岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 05 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 No longer recruiting
Date of protocol fixation
2013 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 06 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

Management information
Registered date
2013 Year 10 Month 30 Day
Last modified on
2018 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014226

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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