Pancreatic Diseases Requiring Distal Pancreatectomy
Conditions
Interventions
Application of the Pancreatic Transection Time Reduction Protocol (Three-Minute Method)
Sponsors
Fukushima Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Indication for Distal Pancreatectomy *Patients with diseases requiring distal pancreatectomy based on abdominal contrast-enhanced CT, regardless of the underlying condition. *A pathological diagnosis is not mandatory. *Variations in surgical methods, such as spleen preservation or lymphadenectomy, are acceptable. *Prior neoadjuvant chemotherapy or radiation therapy does not exclude participation. *The thickness of the pancreas at the planned transection site is not a limitation. 2) No Involvement of Specific Organs *No evidence of invasion into organs other than the adrenal gland and spleen. No invasion into the portal vein. 3) No Gastrointestinal Resection *Procedures requiring resection of the gastrointestinal tract are excluded. 4) No Prior Pancreatic Surgery *Patients with a history of pancreatic surgery are excluded. 5) Age Requirement *Patients aged 18 years or older on the date of obtaining consent. 6) Performance Status (PS) *PS of 0 or 1 based on the Eastern Cooperative Oncology Group (ECOG) criteria. 7) Laboratory Test Results *The most recent test results within 28 days prior to registration meet the following criteria: - Neutrophil count >= 1200/mm3 - Hemoglobin >= 9.0 g/dL - Platelet count >= 75000/mm3 - Total bilirubin <= 2.5 mg/dL - AST <= 150 U/L
Exclusion criteria
Exclusion criteria: 1. Severe Infections *Patients with infections requiring systemic treatment. 2. Fever *Patients with a body temperature of >=38.0C at the time of registration. 3. Pregnancy and Related Conditions *Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding. *Men whose partners are planning to become pregnant. 4. Mental Health Conditions *Patients with mental illness or psychiatric symptoms that interfere with daily life and are deemed unsuitable for study participation. 5. Use of Immunosuppressive Therapy *Patients receiving continuous systemic administration of steroids or other immunosuppressive agents (oral or intravenous). 6. Severe Comorbidities *Patients with severe complications such as: - Heart failure: ACCF/AHA Stage C or higher. - Renal failure: Patients undergoing maintenance dialysis. - Liver failure: Child-Pugh classification Grade B or higher. - Uncontrolled hypertension: Systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg, even with antihypertensive medication. - Other conditions: Hemorrhagic peptic ulcers, bowel obstruction, etc. 7. Allergy to Iodine-Based Contrast Agents *Patients unable to use iodine-based contrast agents due to drug allergies, renal dysfunction, or bronchial asthma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of Grade B/C postoperative pancreatic fistula (POPF) | — |
Countries
Japan
Contacts
Public ContactTeruhide Ishigame
Fukushima Medical University Department of Hepato-Biliary-Pancreatic and Transplant Surgery
Outcome results
None listed