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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011458
Receipt No. R000012249
Scientific Title The efficacy of modified hemostasis forceps for gastric ESD
Date of disclosure of the study information 2013/08/25
Last modified on 2019/12/18

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Basic information
Public title The efficacy of modified hemostasis forceps for gastric ESD
Acronym The efficacy of modified hemostasis forceps
Scientific Title The efficacy of modified hemostasis forceps for gastric ESD
Scientific Title:Acronym The efficacy of modified hemostasis forceps
Region
Japan

Condition
Condition early gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficasy of new hemostasis forceps for bleeding during gstric ESD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes hemostatic time for initial bleeding
Key secondary outcomes hemostatic time for all bleeding
procedure time
complication

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 standard hemostasis forceps
Interventions/Control_2 modified hemostasis forceps
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. early gastric cancer that meet the criteria for ESD proposed by Japanese Gastric Cancer Society(those with a preoperative diagnosis of differentiated type intramucosal cancer without ulcer findings; differentiated type intramucosal cancer that was no longer than 3cm in diameter with ulcer findings; differentiated-type minute invasive submucosal cancer (invasion less than 0.5mm below the muscularis mucosa) that was no longer than 3cm in diameter; and undifferentiated-type intramucosal cancer that was no longer than 2 cm in diameter without ulcer finding.)
2. tumor size less than 60mm in diameter
Key exclusion criteria 1. leison including ulcer
2. patient recieving antithrombotic medication
3. patients with severe liver cirrhosis
4. dialysis patient
5. patient with compromized blood clotting
Target sample size 66

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinwa Tanaka
Organization Kobe University Hospital
Division name Endoscopy
Zip code
Address 7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan
TEL 078-382-5111
Email tanakas@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinwa Tanaka
Organization Kobe University Hospital
Division name Endoscopy
Zip code
Address 7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan
TEL 078-382-5111
Homepage URL
Email tanakas@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
Institute
Department

Funding Source
Organization none
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
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

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 25 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/27648821
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/27648821
Number of participants that the trial has enrolled 57
Results Hemostasis time for the first bleeding episode during ESD was 73.0 seconds for the Coagrasper and 21.5 seconds for the FD-Y0007 (p < 0.001). When all episodes of bleeding were included, hemostasis time was 56.8 seconds in the Coagrasper group and 25.5 seconds in FD-Y0007group (p < 0.0001). The frequency of adverse events (perforation: 3.4% vs. 7.1%; delayed bleeding: 0% vs. 0%) was not significantly different between the two groups.

Results date posted
2019 Year 12 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Coagraspergroup:29patients
Median age: 72years old
Male/Female: 20/9

FD-Y0007group 28patients
Median age:71years old
Male/Female: 18/10
Participant flow Sixty-six patients were enrolled. After randomization, 33 patients were assigned to each group. Four patients in the Coagrasper group and 5 patients in the FD-Y0007 group were excluded because there were no bleeding episodes that required use of the hemostatic forceps. A total of 29 patients in the Coagrasper group and 28 patients in the FD-Y0007 group were analyzed
Adverse events Perforation:
Coagrasper group 3.4%
FD-Y0007 group 7.1%

Delayed bleeding:
Coagrasper group 0%
FD-Y0007 group 0%
Outcome measures The time required to obtain hemostasis, which was measured for the first episode of bleeding during ESD
The mean time to obtain hemostasis for all episodes of bleeding
The rate of achieving hemostasis in 2 or fewer grasping attempts
The procedure times
Adverse event
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 01 Day
Last follow-up date
2014 Year 06 Month 30 Day
Date of closure to data entry
2014 Year 07 Month 30 Day
Date trial data considered complete
2014 Year 10 Month 31 Day
Date analysis concluded
2014 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 12 Day
Last modified on
2019 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012249

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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