UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011058 |
|---|---|
| Receipt number | R000012941 |
| Scientific Title | The safety and efficacy of the endoscopic tissue shielding method with polyglycolic acid sheets for wounds after endoscopic submucosal dissection |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2017/07/02 00:05:56 |
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Basic information
Public title
The safety and efficacy of the endoscopic tissue shielding method with polyglycolic acid sheets for wounds after endoscopic submucosal dissection
Acronym
study on 'Beri-Neo' method after ESD
Scientific Title
The safety and efficacy of the endoscopic tissue shielding method with polyglycolic acid sheets for wounds after endoscopic submucosal dissection
Scientific Title:Acronym
study on 'Beri-Neo' method after ESD
Region
| Japan |
Condition
Condition
gastrointestinal neoplasms to be resected by endoscopic submucosal dissection (ESD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility, safety and efficacy of the covering method with Neoveil and Beriplast for mucosal defects after ESD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
The rate of complications after ESD in conjunction with the covering method with Neoveil and Beriplast.
Key secondary outcomes
procedure time / success rate of covering / complications associated with the procedure / body temperature, the number of white blood cell, the value of C-reactive protein, and the presence of abdominal pain the next day after ESD
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Covering mucosal defects made after ESD with Neoveil and Beriplast
Interventions/Control_2
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
Adult patients who will undergo ESD at our hospital and have given written informed consent to this study. And those who have a risk of developing complications: (1) ESD for large neoplasm is scheduled; (2) heparinization during cessation of antithrombotic drugs is applied; and so on.
Key exclusion criteria
1. Those who fall under the category of contraindication of Neoveil or Beriplast.
Neoveil: those who have systematic complications
Beriplast:
1) those who have a history of anaphylaxis to components of Beriplast or drugs made of bovine lung, such as aprotinin
2) those who are treated with procoagulants (hemocoagulase made from snake venom), antifibrolytic agents, and aprotinin
2. Those who are considered to be inappropriate for this study by doctors
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Fujishiro |
Organization
Graduate School of Medicine, University of Tokyo
Division name
Department of endoscopy and endoscopic surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
mtfujish-kkr@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Tsuji |
Organization
Graduate School of Medicine, University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
ytsuji-tky@umin.ac.jp
Sponsor or person
Institute
the Department of Gastroenterology, Graduate School
of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, University of Tokyo
Organization
Division
Category of Funding Organization
Self funding
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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | 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 | 06 | Month | 28 | Day |
Last modified on
| 2017 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012941
