Status:
NOT_YET_RECRUITING
Comparison of Kimura Versus Warshaw Technique for Laparoscopic Spleen-Preserving Distal Pancreatectomy
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Tianjin Medical University Cancer Institute and Hospital
Qilu Hospital of Shandong University
Conditions:
Pancreatic Tumor, Benign
Pancreatic Neuroendocrine Tumor
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study aims to compare the surgical outcomes of laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique versus the Warshaw technique. The primary focus is on the rates of u...
Detailed Description
For benign and low-grade malignant tumors of the pancreatic body and tail, laparoscopic distal pancreatosplenectomy (LDP) is commonly recommended due to its shorter hospital stay, lower intraoperative...
Eligibility Criteria
Inclusion
- Age between 18 and 70 years, regardless of gender.
- Preoperative clinical diagnosis of benign or low-grade malignant pancreatic tumors.
- Meeting the recommended surgical indications as per guidelines.
- Feasibility of imaging assessment for either Kimura or Warshaw technique laparoscopic spleen-preserving distal pancreatectomy.
- Performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) score.
- Willingness to comply with the study treatment plan, follow-up schedule, and other protocol requirements.
- Voluntarily participating in the study and signing an informed consent form.
Exclusion
- Body Mass Index (BMI) \> 28 kg/m2 (Chinese obesity standard).
- History of blood disorders, acute or chronic pancreatitis, gastrointestinal bleeding, splenic rupture, or gastric varices (preoperative CT indicating curved vessel structures along the gastric wall with a diameter \> 5mm).
- History of abdominal surgery.
- Concomitant primary malignant tumors.
- Suspicion of malignancy based on PET-CT or other imaging examinations.
- Severe impairment of cardiac, liver, or kidney function (NYHA class 3-4, ALT and/or AST exceeding three times the upper limit of normal, Creatinine exceeding the upper limit of normal).
- Planned pregnancy or pregnancy and lactating women.
- Participants currently involved in other clinical trials.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06167421
Start Date
January 1 2024
End Date
December 31 2027
Last Update
December 12 2023
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