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Comparison of three-sided and single-sided mattress pancreaticojejunostomy in pancreatoduodenectomy -Randomized controlled trial-

Comparison of three-sided and single-sided mattress pancreaticojejunostomy in pancreatoduodenectomy -Randomized controlled trial- - Comparison of three-sided and single-sided mattress pancreaticojejunostomy in pancreatoduodenectomy -Randomized controlled trial-

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056623
Enrollment
80
Registered
2025-01-05
Start date
2024-12-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic head tumor

Interventions

Group A: Modified Blumgart suture method (conventional treatment group) During pancreaticoduodenectomy, the modified Blumgart suture method is used for pancreaticojejunostomy. For anastomosis, 5-0PDS

Sponsors

Tokai University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients scheduled for pancreaticoduodenectomy who have been determined to have a soft pancreas. (2) Preoperative CT images show that the pancreatic duct diameter at the planned site of pancreatic resection is 5mm or less. (3) ECOG Performance Status (PS) is 0-1. (4) Age 18 years or older. (5) Function of major organs (bone marrow, heart, liver, kidneys, lungs, etc.) is maintained. (6) Patients have sufficient judgment to understand the content of the research, and written consent has been obtained from the individual.

Exclusion criteria

Exclusion criteria: (1) Patients with severe ischemic heart disease (2) Patients with liver cirrhosis or active hepatitis (3) Patients with respiratory distress requiring oxygen due to interstitial pneumonia or pulmonary fibrosis (4) Patients undergoing dialysis due to chronic renal failure (5) Patients requiring combined resection of surrounding organs (6) Patients requiring arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc. (7) Patients with active duplicate cancers that may affect adverse events or overall survival (8) Patients taking oral steroids for a long period that may affect adverse events (9) Patients with insufficient decision-making ability (10) Other subjects deemed inappropriate by the principal investigator or investigator

Design outcomes

Primary

MeasureTime frame
Incidence of pancreatic fistula ISGPF grade B or C

Secondary

MeasureTime frame
Surgery-related factors, incidence of postoperative complications, incidence of remnant pancreatitis, pancreatic endocrine function, pancreatic exocrine function

Countries

Japan

Contacts

Public ContactShigenori Ei

Tokai University Department of Gastrointestinal Surgery

ei.shigenori.h@tokai.ac.jp0463931121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026