UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015927 |
|---|---|
| Receipt number | R000018539 |
| Scientific Title | The multicenter randomized controlled trial on the effect of Helicobacter pylori eradication for endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2017/06/14 13:04:51 |
* 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
The multicenter randomized controlled trial on the effect of Helicobacter pylori eradication for endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing
Acronym
The multicenter randomized controlled trial on the effect of HP eradication in healing of artificial ulcer after ESD
Scientific Title
The multicenter randomized controlled trial on the effect of Helicobacter pylori eradication for endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing
Scientific Title:Acronym
The multicenter randomized controlled trial on the effect of HP eradication in healing of artificial ulcer after ESD
Region
| Japan |
Condition
Condition
Patients have early gastric cancer endoscopic therapeutic indications lesions and adaptation expanding lesions, are Helicobacter pylori infection including the adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I examine whether endoscopic gastric submucosal dissection is Helicobacter pylori (HP) eradication in healing after (ESD) artificial ulcer involved.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Artificial ulcer healing rate after ESD enforcement 56 days
Key secondary outcomes
Reduction ratio of ESD after artificial ulcer, adverse events incidence
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
do HP eradication after ESD
Interventions/Control_2
donot performed HP eradication after ESD
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
Patients who agreed to participate in this study by the description document.
20 years of age and older adults.
Patients Helicobacter pylori infection has been confirmed.
Patient is determined to be the resected lesion in ESD.
Patients adenoma or depth of invasion has been diagnosed with intramucosal cancer.
Performance status is 0, 1, 2 patients.
Key exclusion criteria
Patients by narrowing and deformation of the upper gastrointestinal tract, drug administration and the endoscope insertion can be considered difficult.
Patients with complications of active malignancy or other serious systemic.
Patients with active ulcer.
Serious complications, patients with (heart failure, renal failure than (creatinine clearance 60 (mL / min)), liver failure, respiratory failure).
Patients on dialysis.
Patients with a history of allergy to the study drug.
Patients during pregnancy and lactation.
Patients with a history of radiation therapy to the upper abdomen.
Esophageal lesions, and patients who are scheduled for endoscopic therapy at the same time against duodenal lesions.
Patients with registration history in this study.
Patients who did not consent to participate in this clinical study.
Others, patients who test responsibility (sharing) doctor has determined to be inappropriate as a subject.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Sasaki |
Organization
Aichi Medical University
Division name
Gastroenterology
Zip code
Address
1-1 YazakoKarimata, Nagakute, Aichi 480-1195, Japan
TEL
0561-62-1508
msasaki@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Shimozato |
Organization
Aichi Medical University
Division name
Gastroenterology
Zip code
Address
1-1 YazakoKarimata, Nagakute, Aichi 480-1195, Japan
TEL
0561-62-1508
Homepage URL
shimozato.akihiro.274@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
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
| 2015 | Year | 01 | Month | 01 | 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
| 2014 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 12 | Day |
Last modified on
| 2017 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018539
