Japanese multicenter, randomized trial of endoscopic stenting for the nonresectable pancreatic head cancer (JM-Test)

UMIN ID: C000000388

Registered date:01/04/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: nonresectable pancreatic head cancer
• Date of first enrollment: 2005/10/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

When a tumor mass is detected based on diagnostic imaging including US and CT, and tumor-related obstructive jaundice is suspected, we determine whether it is pancreas cancer or not by endoscopic pancreatic cholangiography and perform endoscopic retrograde biliary drainage. At this stage, in principle, endoscopic nasobiliary biliary drainage (ENBD) is performed or the plastic stent is placed. While alleviating jaundice, we determine if surgery can be carried out or not. Meanwhile, patients whose tumor is determined as unresectable up to this point are enrolled in the trials for placement of a designated stent(Plastic stent).
When a tumor mass is detected based on diagnostic imaging including US and CT, and tumor-related obstructive jaundice is suspected, we determine whether it is pancreas cancer or not by endoscopic pancreatic cholangiography and perform endoscopic retrograde biliary drainage. At this stage, in principle, endoscopic nasobiliary biliary drainage (ENBD) is performed or the plastic stent is placed. While alleviating jaundice, we determine if surgery can be carried out or not. Meanwhile, patients whose tumor is determined as unresectable up to this point are enrolled in the trials for placement of a designated stent(Covered Metallic Stent).

Outcome(s)

• Primary Outcome: Stent patency and occulusion rate
• Secondary Outcome: Survival, Cost effectiveness, Types and frequency of complications

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: Patients with cancer endoscopically accessible Patients with cancer endoscopically accessible Patients with performance status 4 (See Appendix) Patients with severe complications on other organs (>=stage 3 of ASA classification) except dialysis patients Patients without an informed consent Patients determined as not eligible by doctors in charge. Patients with intraductal papillary-mucinous tumor:(IPMT)

Related Information

• Primary Sponsor: Faculty of Medicine, University of Tokyo
• Source(s) of Monetary Support: nothing