A pilot study of the safety and efficacy of stapler for transection of the pancreatic parenchyma during pancreaticoduodenectomy

A pilot study of the safety and efficacy of stapler for transection of the pancreatic parenchyma during pancreaticoduodenectomy - A pilot study of the safety and efficacy of stapler for transection of the pancreatic parenchyma during pancreaticoduodenectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049961

Enrollment

Registered

2023-01-10

Start date

2022-09-01

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients judged to have a normal pancreas among those scheduled for pancreaticoduodenectomy. 2) The thickness of the pancreatic parenchyma can be cut with an automatic suturer. 3) ECOG Performance Status (PS) is 0-1. 4) Age over 20 years old. 5) The functions of major organs (bone marrow, heart, liver, kidney, lung, etc.) are maintained. 6) Has sufficient judgment to understand the content of the research, and has obtained written informed consent from the individual.

Exclusion criteria

Exclusion criteria: 1) Patients with severe ischemic heart disease 2) Patients with cirrhosis or active hepatitis 3) Patients with dyspnea requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis 4) Patients undergoing dialysis for chronic renal failure 5) Cases requiring combined resection of surrounding organs 6) Patients considered to require arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc. 7) Active double cancer that may affect adverse events or overall survival 8) Long-term oral steroid use that may affect adverse events 9) Patients who are complicated by psychosis or psychiatric symptoms and judged to be difficult to participate in the study 10) History of gastrectomy, colectomy or rectal resection 11) Patients who cannot use both iodine-based drugs and gadonium-based drugs due to severe drug allergies

Design outcomes

Primary

Measure	Time frame
the rate of postoperative pancreatic fistula (ISGPF; GradeB or C)	—

Countries

Japan

Contacts

Public ContactYuji Kitahata

Wakayama medical university 2nd department of surgery

yuji-kh@wakayama-med.ac.jp0734410613

Outcome results