Comparison of Kimura Versus Warshaw Technique for Laparoscopic Spleen-Preserving Distal Pancreatectomy

Launched by FUDAN UNIVERSITY · Dec 4, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to compare two different surgical methods, called the Kimura technique and the Warshaw technique, for a specific type of surgery known as laparoscopic spleen-preserving distal pancreatectomy. This surgery is done to remove tumors from the pancreas while trying to keep the spleen intact. The study aims to find out which technique results in fewer unexpected spleen removals and severe complications, as well as to assess the overall outcomes during and after the surgery.

To participate in this trial, candidates must be between 18 and 70 years old and have a diagnosis of benign or low-grade pancreatic tumors. They should be in good overall health and willing to follow the study's treatment plan and check-up schedule. However, individuals with certain health conditions, a high body weight, or those who have had previous abdominal surgeries or serious health issues may not be eligible. The trial is not yet recruiting participants, but it's an important step toward improving surgical options for patients with specific pancreatic tumors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.