Unique ID issued by UMIN | UMIN000003592 |
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Receipt number | R000004343 |
Scientific Title | Clinical study for the confirmation of the clinical usefulness of new endoscopic device (high-frequency cap-knife, XFF621A) |
Date of disclosure of the study information | 2010/05/15 |
Last modified on | 2010/05/11 00:48:00 |
Clinical study for the confirmation of the clinical usefulness of new endoscopic device (high-frequency cap-knife, XFF621A)
Confirmatory study for the clinical usefulness of new endoscopic device (high-frequency cap-knife, XFF621A)
Clinical study for the confirmation of the clinical usefulness of new endoscopic device (high-frequency cap-knife, XFF621A)
Confirmatory study for the clinical usefulness of new endoscopic device (high-frequency cap-knife, XFF621A)
Japan |
Early gastric, esophageal and rectal cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To confirm the safety of new high-frequency knife (XFF621A) exclusively for endoscopic submucosal dissection
Safety
Frequency and severity of adverse event
En-bloc resection rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Endoscopic submucosal dissection
20 | years-old | <= |
75 | years-old | >= |
Male and Female
(1)Depth of invasion was limited to the mucosa or thin layer of submucosa (evaluated by endoscopy and /or endoscopic ultrasonography).
(2) N0M0 eavluated by CT scan (if submucosal invasion was suspected).
(3) Performance status(ECOG) is 0 or 1.
(4) fulfill all the criteria indicated below (within 30 days before treatment, ULN: upper limit of the institution).
i) white blood cell count
no fewer than 3000/mm3
no more than 10000/mm3
ii) hemoglobin
more than 9.0 g/dl(No blood transfusion was done within 14 days before treatment).
iii) platelet count
more than 100,000/mm3
iv) GOT
less or equal ULN X2.5
v) GPT
less or equal ULN X2.5
vi) T-Bil
less or equal 3.0mg/ml
vi) serum creatinine
less or equal 2.0mg/ml
(5) Written informed consent is essential.
(1) Cases with the component of poorly differetiated carcinoma in the biopsy specimen.
(2) Cases with active multiple cancers.
(3) Cases with severe complication.(i.e., decompensated liver cirrhosis, severe ischemic heart disease, renal failure, poorly-controlled diabetes mellitus, chronic respiratory failure requiring for continuous oxygen administration, Discontinuation of anticoagulant therapy can not be allowed).
(4) Woman in pregnancy (or woman of child bearing potential) and breast-feeding woman.
(5) Cases with uncontrolled psychiatric disease.
15
1st name | |
Middle name | |
Last name | Shin'ichi Miyamoto |
Kyoto University
Department of Gatroenterology and Hepatology
54 Sho-goin Kawaharachou, Sakyo-ku, Kyoto, Japan
1st name | |
Middle name | |
Last name |
Kyoto University
Department of Gatroenterology and Hepatology
075-751-4319
Kyoto University
FUJIFILM Corporation
Profit organization
NO
2010 | Year | 05 | Month | 15 | Day |
Unpublished
Completed
2007 | Year | 11 | Month | 05 | Day |
2008 | Year | 01 | Month | 01 | Day |
2010 | Year | 05 | Month | 11 | Day |
2010 | Year | 05 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004343
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