Not Yet RecruitingNot Applicable

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

240 participantsStarted 2024-01-01

Plain-language 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 unplanned splenectomy, occurrence of severe complications, as well as intraoperative and perioperative outcomes of both techniques.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compares two surgical techniques — the Kimura and Warshaw methods — for removing part of the pancreas while keeping the spleen; can you explain what the main difference is between these two approaches and which one you currently use for cases like mine?
2Since this trial is not yet recruiting, how long might it be before I could actually enroll, and would waiting for it delay my treatment in a way that could affect my outcome?
3The trial is measuring 'unplanned splenectomy rate,' meaning the spleen sometimes has to be removed unexpectedly during this type of surgery — how common is that risk, and what would losing my spleen mean for my long-term health?
4This study is listed as 'Phase NA,' which suggests it's a surgical technique comparison rather than a drug trial — does that mean the safety profile of the surgery itself is already well understood, or are there still unknowns about how these two techniques compare?
5Given that my diagnosis involves a benign or low-grade tumor, is a spleen-preserving approach definitely the right goal for my specific situation, and would standard surgery outside of a trial be a reasonable alternative to consider first?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Unplanned splenectomy rate

Timeframe: Immediately after the surgery.

Severe complication rate

Timeframe: Within 90 days after surgery.

Trial details

NCT IDNCT06167421

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Xianjun Yu, MD, PhD

+86-13801669875 yuxianjun@fudanpci.org

View on ClinicalTrials.gov More Pancreatic Tumor, Benign trials