UMIN-CTR Clinical Trial

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

gastrointestinal stromal tumor

Classification by specialty

Medicine in general

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name	Yoshihiro
Middle name
Last name	Ogawa

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Medicine and Bioregulatory Science

Zip code

8128582

Address

3-1-1, Maidasi, Higashi-ku, Fukuoka, 812-8582 Japan

TEL

092-642-5286

Email

t.osoegawa@gmail.com

Name of contact person

1st name	Takashi
Middle name
Last name	Osoegawa

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Endoscopic Diagnostics and Therapeutics

Zip code

8128582

Address

3-1-1, Maidasi, Higashi-ku, Fukuoka, 812-8582 Japan

TEL

092-641-1151

Homepage URL

Email

t.osoegawa@gmail.com

Institute

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

Institute

Department

Personal name

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

Co-sponsor

National kyushu medical center
Kyushu rosai hoospital

Name of secondary funder(s)

Organization

Kyushu University Medical District Department Ethics Committee

Address

3-1-1, Maidasi, Higashi-ku, Fukuoka, 812-8582 Japan

Tel

092-641-1151

Email

ijkseimei@jimu.kyushu-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2013

Year

11

Month

05

Day

URL releasing protocol

http://www.intmed3.med.kyushu-u.ac.jp/uploads/ck/admin/files/20180416_172731.pdf

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/30723945/

Number of participants that the trial has enrolled

50

Results

Results: A total of 47 patients were randomized to the MIAB
group (n = 23) and EUS-FNA group (n = 24). There was no
significant difference in the diagnostic yield of MIAB and EUSFNA
(91.3% vs 70.8%, P = 0.0746). The complication rates of
MIAB and EUS-FNA did not differ to a statistically significant
extent. The mean procedure time in the MIAB group was
significantly longer than that in the EUS-FNA group (34 vs
26 min, P = 0.0011).

Results date posted

2021

Year

03

Month

18

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2019

Year

04

Month

02

Day

Baseline Characteristics

consecutive patients (>20 years old) with gastric SEL with intraluminal growth pattern, judged according to endoscopic findings, who met the following inclusion criteria on EUS(UM2000, UM-2R and 3R Olympus Optical, Tokyo, Japan) were recruited tumor diameter, 1 5 cm and lesions suspected to have arisen from the muscularis propria layer. Patients with anticoagulation therapy, coagulopathy, contraindications for esophagogastroduodenoscopy, extraluminal growth pattern on computed tomography and those who were unable to provide informed consent were
excluded. An intraluminal growth pattern was defined as growth in an intraluminal direction, regardless of whether or not any extraluminal growth was present.

Participant flow

This was a prospective, randomized, open cross-over study
conducted at three tertiary-care medical centers: Kyushu
University Hospital, Kyushu Rosai Hospital and Kyushu
Medical Center. After reconfirming the consent status,
patients were randomized into the MIAB and EUS-FNA
groups based on the method applied to obtain samples.
Patients in both groups were surveyed for at least 14 days
after discharge in order to record postoperative adverse
events. Patients who were not diagnosed were subsequently
crossed over to the other method. Patients diagnosed with a
GIST were offered surgical resection.
The current study was approved by the Clinical Ethics
Committee of Kyushu University Hospital in accordance
with the Declaration of Helsinki and was registered in the
University Hospital Medical Information Network Clinical
Trials Registry (UMIN 000012169) following the
CONSORT checklist. All patients provided their written
informed consent to undergo the procedures and participate
in the study.

Adverse events

none

Outcome measures

The primary outcome measure was the diagnostic yield of
EUS-FNA and MIAB, defined as the percentage of lesions
confirmed by a pathological diagnosis based on both
morphology and immunohistochemistry. The secondary
outcome measures were the technical success rate, complication
rate, procedure time and biopsy frequency of
technically successful cases. Technical success was defined
as obtaining a visible tissue specimen or fragments by
accessing the target. Complications were defined as any
deviation from the clinical course during the procedure,
hospitalization or within 14 days after discharge (identified
by a survey).22 The EUS-FNA procedure time was defined
as the time from the start of the EUS examination until the
end of the procedure, including the EUS-FNA procedure;
the MIAB procedure time was defined as the time from the
start of marking until clip closure. The biopsy frequency was
defined as the number of times the endoscopist biopsied the
target lesion in the MIAB and the number of times the
needle passed the target lesion in EUS-FNA.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2013

Year

06

Month

01

Day

Date of IRB

2013

Year

06

Month

01

Day

Anticipated trial start date

2013

Year

06

Month

01

Day

Last follow-up date

2020

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

10

Month

30

Day

Last modified on

2021

Year

03

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014226