UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety and efficacy of the endoscopic tissue shielding method with polyglycolic acid sheets for wounds after endoscopic submucosal dissection
Title of the study (Brief title)	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	Mitsuhiro Fujishiro
Organization	Graduate School of Medicine, University of Tokyo
Division name	Department of endoscopy and endoscopic surgery
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	Yosuke Tsuji
Organization	Graduate School of Medicine, University of Tokyo
Division name	Department of Gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000012941