Three-sided mattress pancreaticojejunostomy in pancreatoduodenectomy: A Single-arm Pilot Study

UMIN ID: UMIN000056625

Registered date:04/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diseases in the pancreatic head region
• Date of first enrollment: 2024/04/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: the rate of postoperative pancreatic fistula (ISGPF; GradeB or C)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Serious ischemic heart disease. 2) Complication of liver cirrhosis or active hepatitis. 3) Dyspnea requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis. 4) Undergoing dialysis for chronic renal failure. 5) Requiring combined resection of surrounding organs. 6) Considered to require arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc. 7) Active double cancers that may affect adverse events or overall survival. 8) Long-term oral steroid use that may cause adverse events. 9) Psychosis or psychiatric symptoms judged to potentially cause difficulty in participation in the study. 10) Any other person who the principal investigator or researcher deems inappropriate.

Related Information

• Primary Sponsor: Tokai University
• Source(s) of Monetary Support: Self funding