About this trial
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 unplanned splenectomy, occurrence of severe complications, as well as intraoperative and perioperative outcomes of both techniques.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique
Procedure/SurgeryThe laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique is defined as a surgical procedure that aims to remove the distal part of the pancreas while preserving the spleen by maintaining the splenic artery and vein (Hepatogastroenterology. 2003;50:2242).
Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique
Procedure/SurgeryWarshaw technique laparoscopic spleen-preserving distal pancreatectomy is defined as a surgical procedure that aims to preserve the spleen while removing the distal part of the pancreas. It involves ligating the splenic artery and vein, while preserving the left gastroepiploic artery and short gastric vessels (Arch Surg. 1988;123:550).
Treatment groups
Trial outcomes
Primary outcomes
Unplanned splenectomy rate
The unplanned splenectomy rate in both groups will be calculated, and detailed records of the specific reasons will be documented, such as adhesions, bleeding, intraoperative splenic infarction.
Severe complication rate
The rate of severe complications will be assessed by evaluating the severity of postoperative complications using the Clavien-Dindo classification system. In this classification system, complications graded as III and above are considered severe complications.
Secondary outcomes
Spleen vessel preservation rate
The spleen vessel preservation rate refers to the rate at which the spleen vessels are successfully preserved during surgery. In cases where the Kimura technique is unable to preserve the spleen vessels, salvage Warshaw procedure or splenectomy may be performed. This can include modified Warshaw procedures that involve the simple removal of the splenic artery or splenic vein.
Postoperative Clinically Relevant Spleen Ischemia (CRSI) rate
CRSI is defined as the occurrence of spleen ischemia requiring splenectomy during either the initial hospitalization or subsequent readmissions. The reasons for the second splenectomy will be recorded.
Postoperative quality of life assessment
The evaluation will be conducted using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). The EORTC QLQ-C30 is a widely used questionnaire to assess the quality of life. It consists of multiple scales and items that cover various aspects of physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, global health status, and symptom scales. Each item in the questionnaire is rated on a four-point Likert scale, ranging from 1 (not at all) to 4 (very much). Some items are reverse-scored, meaning that a higher score indicates a worse outcome. The scores for each scale are then transformed to a 0-100 scale, where a higher score represents a better outcome for functioning scales and a worse outcome for symptom scales.
Locations
Sponsors and contacts
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Fudan University
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
The Third Affiliated Hospital of Soochow University
Collaborator
Tongji Hospital
Collaborator
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