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NCT06167421Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 12 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
240 (estimated)
First submitted
20 Nov 2023
Start date
1 Jan 2024
Primary completion date
31 Dec 2026
Lead sponsor
Fudan University
NCT number
NCT06167421

What you commit to

  • Study type: Interventional
  • Planned participants: 240
  • From 1 Jan 2024 to the primary completion date, 31 Dec 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant primary malignant tumors.

Other illness

  • 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.
  • Suspicion of malignancy based on PET-CT or other imaging examinations.

Lab values

  • 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).

Other

  • Body Mass Index (BMI) \> 28 kg/m2 (Chinese obesity standard).
  • Planned pregnancy or pregnancy and lactating women.
  • Participants currently involved in other clinical trials.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.