Unique ID issued by UMIN | UMIN000005434 |
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Receipt number | R000006449 |
Scientific Title | Phase I trial for safety and feasibility of steady pressure automatically controlled endoscopy (SPACE). |
Date of disclosure of the study information | 2011/04/14 |
Last modified on | 2013/09/10 06:44:46 |
Phase I trial for safety and feasibility of steady pressure automatically controlled endoscopy (SPACE).
Phase I trial for SPACE.
Phase I trial for safety and feasibility of steady pressure automatically controlled endoscopy (SPACE).
Phase I trial for SPACE.
Japan |
Superficial esophageal cancer
Gastroenterology |
Malignancy
NO
To evaluate the safety and feasibility of steady pressure automatically controlled endoscopy (SPACE) for patients with esophageal epithelial neoplasm
Safety
Rate of adverse event (based on NCI-CTCAE ver. 4.0)
1) Completion rate of ESD
2) The changes of pCO2 before and after ESD
3) The changes of vital signs during ESD
4) En bloc margin negative rate of ESD
5) Procedure duration
6) Patients' subjective symptom
7) Dosage amount of sedative during ESD
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Esophageal ESD with steady pressure automatically controlled endoscopy
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) To be diagnosed as SCC or High grade intraepithelial neoplasia by endoscopic forceps biopsy.
2) The invasion depth is diagnosed endoscopically as T1a-EP or T1a-LPM.
3) The lesion occupies less than 2/3 of the circumference of esophagus.
4) Without past history of esophagectomy.
5) Not to be involved cervical esophagus or esophago-gastro junction.
6) The age is more than 20 and less than 80.
7) PS (ECOG) is 0 or 1.
8) Not to show significant abnormality by respiratory function test.
9) Main organ function is maintained by blood sampling.
10) Written informed consent has been obtained.
1) To be affected infectious disease which need systemic treatment.
2) With body temperature higher than 38C
3) To have bleeding tendency.
4) Pregnancy or possibility of pregnancy or breast-feeding woman
5) Psychiatric disease
6) To be treated systemic steroid therapy
7) Unstable angina
8) Uncontrolled hypertension
9) Uncontrolled DM
10) Unable to interrupt anticoaglant for ESD
11) To be judged inapropriate to participate this trial by contact person
10
1st name | |
Middle name | |
Last name | Kiyokazu Nakajima |
Osaka University Graduate School of Medicine
Department of Gastroenterological Surgery
2-2, E-2, Yamadaoka, Suita, Osaka 565-0871, Japan
06-6876-0550
knakajima@surg1.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Kiyokazu Nakajima |
Osaka University Graduate School of Medicine
Department of Gastroenterological Surgery
2-2, E-2, Yamadaoka, Suita, Osaka 565-0871, Japan
06-6876-0550
knakajima@surg1.med.osaka-u.ac.jp
Japan SPACE study group
none
Other
NO
大阪大学医学部付属病院
2011 | Year | 04 | Month | 14 | Day |
Published
The commonly observed adverse events were dysphagia, laryngeal pain, and chest pain, but no adverse event was of grade 3 or more. Mild PaCO2 elevation after ESD was addressed; however, there was no symptom associated with hypercapnia. The procedure was completed under SPACE alone in 8 out of 10 patients. Post-procedural bowel distension was minimal according to the patient visual analogue scale and radiographic grading.
Completed
2011 | Year | 04 | Month | 13 | Day |
2011 | Year | 04 | Month | 01 | Day |
2012 | Year | 06 | Month | 16 | Day |
2013 | Year | 09 | Month | 10 | Day |
2013 | Year | 09 | Month | 10 | Day |
2013 | Year | 09 | Month | 10 | Day |
2011 | Year | 04 | Month | 13 | Day |
2013 | Year | 09 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006449
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