Unique ID issued by UMIN | UMIN000009025 |
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Receipt number | R000010593 |
Scientific Title | Randomized comparison study(III phase)between manual inflation of the room air and Carbon dioxide(Co2) automatic inflation for the colon distension procedure during FDG-PET/C colonograph and CTA simultaneous examination as a preoperative colon cancer. |
Date of disclosure of the study information | 2012/10/03 |
Last modified on | 2012/10/02 19:48:25 |
Randomized comparison study(III phase)between manual inflation of the room air and Carbon dioxide(Co2) automatic inflation for the colon distension procedure during FDG-PET/C colonograph and CTA simultaneous examination as a preoperative colon cancer.
Same as above.
Randomized comparison study(III phase)between manual inflation of the room air and Carbon dioxide(Co2) automatic inflation for the colon distension procedure during FDG-PET/C colonograph and CTA simultaneous examination as a preoperative colon cancer.
Same as above.
Japan |
Colon cancer
Gastrointestinal surgery | Radiology |
Malignancy
NO
To find out an appropriate colon distension procedure during FDG-PET/C colonograph and CTA simultaneous examination(preoperative colon cancer multi-mode fusion examination) as a preoperative colon cancer, compare prospectively the image evaluation, patient comfortability, amount o9f radiation for the operater between manual air inflation and Carbon dioxide(Co2) automatic inflation.
Efficacy
Confirmatory
Pragmatic
Phase III
Colon CT imaging evaluation(intestine and lesion display ability) during preoperative colon cancer multi-mode
fusion examination .
The degree of patient discomfort (pain, a sense of distension)
Comparison of examination times
Radiation dose to the examining staff measured during examination
Estimated patient radiation dose
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
YES
No need to know
2
Diagnosis
Device,equipment |
Manual air insufflation
Automated carbon dioxide insufflation
20 | years-old | <= |
81 | years-old | > |
Female
1.Palliative operation for Colon primary carcinoma
2.Diagnosed colon cancer histologically by endoscopic biopsy from the colon primary carcinoma lesion.
3.The tumor location comprehensively judged using endoscopic exam and preoperative imaging exam( abdomen, pelvis exam) are ceca, ascending colon, hepatic flexure, colon transversem,
splenic fleure,colon descendens, colon signoideum, proctosigmoid, rectum.
4.Radically resectable under the laparoscopic colon resection.
5. Registration age is over 20y, less than 80y.
6.No anamnesis of intestine excision(including stomach, excluding appendectomy)
7.No anamnesis of chemotherapy a/o radiation therapy for treatment of malignancy like other cancer.
8. 0 or 1 of performance status(ECOG)
9. Functions other organotrophics.
10.Acquired Preoperative colon cancer multi-modal fusion exam consent.
11. Performed colon endoscopy exam at Osaka University Hospital just before the pre operative colon cancer multi-modal fusion exam.
12.Acquired patient consent to understand the purpose of this study and patient will to join this clinical study by having thoroughly explanation.
1.Without satisfaction of selection std.
2.Active duplication cancer(synchronia duplication cancer as well as metachronous duplication cancer within 5 years of nondisease period. However, Carcinoma in situ healed by local therapy or lesion cancer in mucosa are not included in the active duplication cancer.)
3.Complicated insanity or mental disorder and judged the difficulty to join this study.
4.Non-controlable Diabates(HbA1c>=8.0%)
5.Need dialysis chronicity renal failure.
6.Continuous constitutional dose of steroid(via peroral or pervenous) or require state of immunosuppressant.
7.Severe heart disease case.
8.Having Pulmonary pneumatosis, fibrosis of lung
9.Continuous ingestion of analgetic including NSAIDs.
10.Complaining bellyache, distension just before the preoperative colon cancer multi-modal fusion exam.
11. In case of stomatosyte produced in Large intestine, small intestine.
12.Difficulity of walk by oneself.
13.In case of sever colon stenosis is informed before the colon cancer preoperative multi-modal fusion exam and study representative doctor or sub representative doctor judged no possibility of inflation to colon intestine.
14. eGFR calculated from Age, sexuality and serum creatine is less than 30 ml/min/1.73m2
15.In case of Iodo anaphyraxis.
16.Sever Anamnesis of thyroiditis
17. Anamnesis of iodo contrast media side effect.
18.Recognized intestine hemorrhage.
19.The others,In case of the doctor incharge judged inappropriate to join this study.
60
1st name | |
Middle name | |
Last name | Seiki Hamada |
Jinsenkai MI Clinic
Radiology
1-12-13,Shoji,Toyonaka,Osaka 560-0004,Japan
06-6840-0100.322
1st name | |
Middle name | |
Last name | Yasuo Iwamoto |
Jinsenkai MI Clinic
Research Secretariat
1-12-13,Shoji,Toyonaka,Osaka 560-0004,Japan
06-6840-0100.311
http://www.jinsen-pet.jp/
iwamoto@jinsen-pet.jp
Jinsenkai MI Clinic
None
Self funding
Japan
Osaka University
gastroenterological surgery
NO
医療法人仁泉会MIクリニック(大阪府)
2012 | Year | 10 | Month | 03 | Day |
Unpublished
Preinitiation
2012 | Year | 09 | Month | 10 | Day |
2012 | Year | 10 | Month | 05 | Day |
2013 | Year | 04 | Month | 30 | Day |
2013 | Year | 04 | Month | 30 | Day |
2013 | Year | 04 | Month | 30 | Day |
2013 | Year | 05 | Month | 31 | Day |
2012 | Year | 10 | Month | 02 | Day |
2012 | Year | 10 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010593
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