Unique ID issued by UMIN | C000000249 |
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Receipt number | R000000314 |
Scientific Title | A phase II study of percutaneous trans-esophageal gastric tubing for malignant gastrointestinal obstruction (JIVROSG-0205) |
Date of disclosure of the study information | 2006/09/01 |
Last modified on | 2005/09/28 14:02:56 |
A phase II study of percutaneous trans-esophageal gastric tubing for malignant gastrointestinal obstruction (JIVROSG-0205)
Percutaneous trans-esophageal gastric tubing (JIVROSG-0205)
A phase II study of percutaneous trans-esophageal gastric tubing for malignant gastrointestinal obstruction (JIVROSG-0205)
Percutaneous trans-esophageal gastric tubing (JIVROSG-0205)
Japan |
Malignant gastrointestinal obstruction
Hepato-biliary-pancreatic medicine | Surgery in general | Gastrointestinal surgery |
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the safety and efficacy of percutaneous trans-esophageal gastric tubing for malignant gastrointestinal obstruction
Efficacy
Explanatory
Phase II,III
Improvement of subjective symptoms compared to previous nasal tubing.
Adverse events and feasibility of procedure
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Under local anesthesia and fluoroscopy or ultrasonic guidance, a percutaneous route to cervical esophagus is made by direct puncture to the intra-esophageal balloon inserted via nasal or oral route, and then, a drainage tube is placed from the neck surface to the stomach using this route.
Not applicable |
Not applicable |
Male and Female
1) No expectation for removal of nasal tube caused by persistent and malignant gastro-intestinal obstruction.
2) No pathological condition around cervical esophagus.
3) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
5) Expected survival more than 4 weeks.
6) Written informed consent.
1) Tracheostomy.
2) Intestinal obstruction due to the lesions between transverse colon and rectum.
3) Pregnancy.
4) Local therapy for neck region
33
1st name | |
Middle name | |
Last name | Takeshi Aramaki |
Shizuoka Cancer Center
Department of Imaging Diagnosis
1007, Shimonagakubo, Nagaizumi-cho, Shuntoh-gun, Shizuoka 411-8777, Japan
1st name | |
Middle name | |
Last name | Yasuaki Arai |
JIVROSG, Coordinating Office
Division of Diagnostic Radiology, National Cancer Center Hospital
5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
0335422511
http://jiprosg.umin.jp/
jvrosgffice@ml.res.ncc.go.jp
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Ministry of Health, Labour and Welfare
Japan
NO
2006 | Year | 09 | Month | 01 | Day |
http://jvrosg.umin.jp/
Unpublished
2002 | Year | 11 | Month | 30 | Day |
2003 | Year | 07 | Month | 01 | Day |
2006 | Year | 05 | Month | 01 | Day |
2006 | Year | 06 | Month | 01 | Day |
2006 | Year | 06 | Month | 01 | Day |
2006 | Year | 09 | Month | 01 | Day |
2005 | Year | 09 | Month | 28 | Day |
2005 | Year | 09 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000314
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