A preventive effect of pancreatic duct stenting to decrease the rate of pancreatic fistula after pancreaticojejunostomy following pancreatoduodenectomy

UMIN ID: UMIN000000952

Registered date:20/12/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: pancreatoduodenectomy for pancreatic head cancer, bile duct cancer, cancer of the Vater's papilla, gallbladder cancer, pancreatic head tumor (Intraductal papillary-mucinous neoplasm, endocrine tumor, other pancreatic tumor), chronic pancreatitis
• Date of first enrollment: 2007/12/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Stented group
Nonstented group

Outcome(s)

• Primary Outcome: Rate and severity of pancreatic fistula
• Secondary Outcome: postoperative morbidity rate, postoperative hospital stay, hospital mortality rate

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)requiring total pancreatectomy 2)unfeasible for pancreaticojejunostomy 3)past history for pancreatectomy 4)other unfeasible factors to study safety, approved attending surgeon 5)pregnancy

Related Information

• Primary Sponsor: Department of surgery, Tohoku University
• Source(s) of Monetary Support: None (self-funding)