A Multicenter Prospective Study on Distal Pancreatectomy Using a Pancreatic Transection Time Reduction Protocol (Three-Minute Method)

UMIN ID: UMIN000056325

Registered date:02/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Pancreatic Diseases Requiring Distal Pancreatectomy
• Date of first enrollment: 2024/12/04
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Application of the Pancreatic Transection Time Reduction Protocol (Three-Minute Method)

Outcome(s)

• Primary Outcome: The incidence rate of Grade B/C postoperative pancreatic fistula (POPF)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Fukushima Medical University
• Source(s) of Monetary Support: Fukushima Medical University