A phase II study of percutaneous trans-esophageal gastric tubing for malignant gastrointestinal obstruction (JIVROSG-0205)

UMIN ID: C000000042

Registered date:06/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Malignant gastrointestinal obstruction
• Date of first enrollment: 2003/07/01
• Target sample size: 33
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Improvement of subjective symptoms compared to previous nasal tubing.
• Secondary Outcome: Adverse events and feasibility of procedure

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Tracheostomy. 2) Intestinal obstruction due to the lesions between transverse colon and rectum. 3) Pregnancy. 4) Local therapy for neck region

Related Information

• Primary Sponsor: Japan Interventional Radiology in Oncology Study Group (JIVROSG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare