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Phase 1 study evaluating the safety of a new pancreaticojejunostomy for pancreaticoduodenectomy

Phase 1 study evaluating the safety of a new pancreaticojejunostomy for pancreaticoduodenectomy - Phase 1 study evaluating the safety of a new pancreaticojejunostomy for pancreaticoduodenectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042389
Enrollment
10
Registered
2020-11-13
Start date
2020-11-13
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 requiring pancreaticoduodenectomy

Interventions

This is a simple technique of making two 8mm holes in the intestinal tract of the jejunal suture site, and covering the site with the pancreatic stump and placing a decompression tube in Roux Y jejuna

Sponsors

University of Tsukuba
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ASA-PS (American Society of Anesthesiologists physical status): 2 or less

Exclusion criteria

Exclusion criteria: Patients with serious ischemic heart disease Patients with cirrhosis of the liver (Child B or higher) or active hepatitis Patients with dyspnea requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis Patients with chronic kidney failure on dialysis Patients requiring complications of resection of other organs BMI over 30. Other cases deemed inappropriate by the doctor

Design outcomes

Primary

MeasureTime frame
Clavien-Dindo classification Grade 3b or higher (including the occurrence of pancreatic fistula of ISGPF Grade B or C)

Countries

Japan

Contacts

Public ContactShinji Hashimoto

University of Tsukuba GI and HBP Surgery

shinji-H@md.tsukuba.ac.jp0298533221

Outcome results

None listed

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