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临床试验/NCT06167421
NCT06167421尚未招募不适用

Comparison of Kimura Versus Warshaw Technique for Laparoscopic Spleen-Preserving Distal Pancreatectomy: A Multicenter Randomized Controlled Clinical Trial

Fudan University0 个研究点目标入组 240 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
240
主要终点
Unplanned splenectomy rate

研究概览

简要总结

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.

详细描述

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 blood loss, and comparable complication rates. The DIPLOMA international multicenter clinical trial further established the non-inferiority of minimally invasive techniques in terms of curative resection for resectable pancreatic body and tail cancers.

As the spleen plays a crucial role in immune defense, splenectomy is associated with increased postoperative infection risk, significant increase in platelet count, and thrombosis. Therefore, for benign and low-grade malignant tumors of the pancreatic body and tail, minimally invasive spleen-preserving distal pancreatectomy should be the preferred approach.

The Kimura technique is the most commonly used and favored spleen-preserving distal pancreatectomy technique. It involves the complete preservation of splenic vessels, resulting in fewer postoperative complications. However, it is time-consuming and challenging due to the identification and ligation of numerous small and short vessels entering the pancreatic body and tail to preserve the fragile splenic artery and vein. On the other hand, the Warshaw technique involves segmental resection of splenic vessels and relies on the left gastroepiploic artery and short gastric vessels for splenic perfusion. It is a simpler procedure with less intraoperative blood loss and shorter operative time. However, it carries an increased risk of postoperative splenic infarction, gastric varices, and secondary bleeding.

Although a higher incidence of splenic infarction has been observed with the Warshaw technique, its clinical relevance remains controversial. Reports indicate that approximately 25% of patients undergoing Warshaw procedure show radiological evidence of asymptomatic gastric varices, but during a follow-up period of up to 21 years, no clinically relevant consequences of gastric varices were observed. Most cases of postoperative splenic infarction are transient and do not require specific treatment. Data from a large pan-European retrospective study showed no significant differences in the clinical incidence of splenic infarction (0.6% vs. 1.6%, P = 0.127) and major complication rates (11.5% vs. 14.4%, P = 0.308) between minimally invasive Kimura and Warshaw techniques.

While Kimura and Warshaw techniques demonstrate comparability in most postoperative outcomes, the former appears to have an advantage in reducing the risk of splenic infarction and gastric varices. Some experts propose a "Kimura-first" strategy. However, there is currently no prospective study comparing these two techniques. Therefore, this study has designed a multicenter randomized controlled clinical trial, focusing on the rates of unplanned splenectomy, severe complication occurrence, and intraoperative and perioperative outcomes of laparoscopic spleen-preserving distal pancreatectomy using the Kimura versus the Warshaw technique. Long-term follow-up will assess clinically relevant outcomes such as splenic ischemia, splenic hyperfunction, gastric varices, and postoperative quality of life. This study aims to provide higher-level evidence in the selection of laparoscopic spleen-preserving distal pancreatectomy techniques.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Unplanned splenectomy rate

时间窗: Immediately after the surgery.

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

时间窗: Within 90 days after surgery.

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.

次要结局

  • Spleen vessel preservation rate(Immediately after the surgery.)
  • Postoperative quality of life assessment(Through study completion, an average of 3 year.)
  • Postoperative Clinically Relevant Spleen Ischemia (CRSI) rate(Through study completion, an average of 3 year.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xian-Jun Yu

President of Fudan University Shanghai Cancer Center

Fudan University

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