Clinical trial · Interventional
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
NCT06167421CI-TRIAL-00072170not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neuroendocrine Tumor | Pancreatic Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Tumor, Benign | Benign Pancreatic Neoplasm | ALIAS | 0.90 |
| Solid Pseudopapillary Tumor of the Pancreas | Solid Pseudopapillary Neoplasm of the Pancreas | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique | Procedure | — | UNRESOLVED |
| Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Kimura group
- description
- Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique.
- interventionNames
- Procedure: Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique
- type
- ACTIVE_COMPARATOR
- label
- Warshaw group
- description
- Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique.
- interventionNames
- Procedure: Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique
Primary outcomes (2)
- measure
- Unplanned splenectomy rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDde Rooij T, van Hilst J, van Santvoort H, Boerma D, van den Boezem P, Daams F, van Dam R, Dejong C, van Duyn E, Dijkgraaf M, van Eijck C, Festen S, Gerhards M, Groot Koerkamp B, de Hingh I, Kazemier G, Klaase J, de Kleine R, van Laarhoven C, Luyer M, Patijn G, Steenvoorde P, Suker M, Abu Hilal M, Busch O, Besselink M; Dutch Pancreatic Cancer Group. Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD): A Multicenter Patient-blinded Randomized Controlled Trial. Ann Surg. 2019 Jan;269(1):2-9. doi: 10.1097/SLA.0000000000002979. PMID 30080726
- BACKGROUNDAsbun HJ, Moekotte AL, Vissers FL, Kunzler F, Cipriani F, Alseidi A, D'Angelica MI, Balduzzi A, Bassi C, Bjornsson B, Boggi U, Callery MP, Del Chiaro M, Coimbra FJ, Conrad C, Cook A, Coppola A, Dervenis C, Dokmak S, Edil BH, Edwin B, Giulianotti PC, Han HS, Hansen PD, van der Heijde N, van Hilst J, Hester CA, Hogg ME, Jarufe N, Jeyarajah DR, Keck T, Kim SC, Khatkov IE, Kokudo N, Kooby DA, Korrel M, de Leon FJ, Lluis N, Lof S, Machado MA, Demartines N, Martinie JB, Merchant NB, Molenaar IQ, Moravek C, Mou YP, Nakamura M, Nealon WH, Palanivelu C, Pessaux P, Pitt HA, Polanco PM, Primrose JN, Rawashdeh A, Sanford DE, Senthilnathan P, Shrikhande SV, Stauffer JA, Takaori K, Talamonti MS, Tang CN, Vollmer CM, Wakabayashi G, Walsh RM, Wang SE, Zinner MJ, Wolfgang CL, Zureikat AH, Zwart MJ, Conlon KC, Kendrick ML, Zeh HJ, Hilal MA, Besselink MG; International Study Group on Minimally Invasive Pancreas Surgery (I-MIPS). The Miami International Evidence-based Guidelines on Minimally Invasive Pancreas Resection. Ann Surg. 2020 Jan;271(1):1-14. doi: 10.1097/SLA.0000000000003590. PMID 31567509
- BACKGROUNDKorrel M, Jones LR, van Hilst J, Balzano G, Bjornsson B, Boggi U, Bratlie SO, Busch OR, Butturini G, Capretti G, Casadei R, Edwin B, Emmen AMLH, Esposito A, Falconi M, Groot Koerkamp B, Keck T, de Kleine RHJ, Kleive DB, Kokkola A, Lips DJ, Lof S, Luyer MDP, Manzoni A, Marudanayagam R, de Pastena M, Pecorelli N, Primrose JN, Ricci C, Salvia R, Sandstrom P, Vissers FLIM, Wellner UF, Zerbi A, Dijkgraaf MGW, Besselink MG, Abu Hilal M; European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trial. Lancet Reg Health Eur. 2023 Jul 6;31:100673. doi: 10.1016/j.lanepe.2023.100673. eCollection 2023 Aug.