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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000056625
Enrollment
20
Registered
2025-01-04
Start date
2024-04-01
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

Diseases in the pancreatic head region

Interventions

None listed

Sponsors

Tokai University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients judged to have soft pancreas among those scheduled for pancreaticoduodenectomy. 2) The diameter of the main pancreatic duct at the planned pancreatic resection site is 5 mm or less on preoperative CT images. 3) ECOG-PS is 0-1. 4) Age 18 years or older. 5) The functions of major organs (bone marrow, heart, liver, kidneys, lungs, etc.) are maintained. 6) Sufficient judgment to understand the content of the research and providing written informed consent.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
the rate of postoperative pancreatic fistula (ISGPF; GradeB or C)

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