Unique ID issued by UMIN | UMIN000008853 |
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Receipt number | R000010393 |
Scientific Title | Clinical study on application of covering method with polyglycolic acid sheet (Neoveil) and fibrin glue (Beriplast) for wounds after endoscopic submucosal dissection for colorectal tumors |
Date of disclosure of the study information | 2012/09/05 |
Last modified on | 2012/12/03 23:34:30 |
Clinical study on application of covering method with polyglycolic acid sheet (Neoveil) and fibrin glue (Beriplast) for wounds after endoscopic submucosal dissection for colorectal tumors
study on 'Beri-Neo method' after colorectal ESD
Clinical study on application of covering method with polyglycolic acid sheet (Neoveil) and fibrin glue (Beriplast) for wounds after endoscopic submucosal dissection for colorectal tumors
study on 'Beri-Neo method' after colorectal ESD
Japan |
Colorectal adenomas or early colorectal cancers to be resected by endoscopic submucosal dissection (ESD)
Gastroenterology |
Malignancy
NO
To evaluate the feasibility of covering method with Neoveil and Beriplast for protecting mucosal defects after colorectal ESD.
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
The extent of remaining Neoveil on the ulcer bed 8 to 14 days after ESD
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 colorectal ESD.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Covering ulcer bed made after colorectal ESD with Neoveil and Beriplast
20 | years-old | <= |
100 | years-old | > |
Male and Female
Adult patients who will undergo colorectal ESD at our hospital and have given written informed consent to this study.
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
10
1st name | |
Middle name | |
Last name | Yosuke Tsuji |
NTT Medical Center Tokyo
Department of Gastroenterology
5-9-22, Higashi-Gotanda, Shinagawa-ku
1st name | |
Middle name | |
Last name |
NTT Medical Center Tokyo
Department of Gastroenterology
NTT Medical Center Tokyo, Department of Gastroenterology
None
Self funding
NO
2012 | Year | 09 | Month | 05 | Day |
Unpublished
Completed
2012 | Year | 08 | Month | 30 | Day |
2012 | Year | 09 | Month | 10 | Day |
2012 | Year | 09 | Month | 04 | Day |
2012 | Year | 12 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010393
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