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2024-01-01
2026-12-31
2027-12-31
240
NCT06167421
Fudan University
Fudan University
INTERVENTIONAL
Comparison of Kimura Versus Warshaw Technique for Laparoscopic Spleen-Preserving Distal Pancreatectomy
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-11-20 | N/A | 2023-12-04 |
2023-12-04 | N/A | 2023-12-12 |
2023-12-12 | N/A | 2023-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Kimura group Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique. | PROCEDURE: Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique
|
| ACTIVE_COMPARATOR: Warshaw group Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique. | PROCEDURE: Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | Immediately after the surgery. |
| 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. | Within 90 days after surgery. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | Immediately after the surgery. |
| 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. | Through study completion, an average of 3 year. |
| 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. | Through study completion, an average of 3 year. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Xianjun Yu, MD, PhD Phone Number: +86-13801669875 Email: yuxianjun@fudanpci.org |
Study Contact Backup Name: Zheng Li, MD Phone Number: +86-18521097686 Email: lizheng@fudanpci.org |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
