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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011058
Receipt No. 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

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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
Email 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
Email ytsuji-tky@umin.ac.jp

Sponsor
Institute the Department of Gastroenterology, Graduate School
of Medicine, The University of Tokyo
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012941

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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