Clinical trial · Observational
Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID)
Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID): Study Protocol for a Prospective Observational International Multicenter Study
- 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)
The goal of this observational study is to determine how often lymph node metastases occur in the splenic hilum and surrounding fat in patients with left-sided pancreatic cancer. The main question the study aims to answer is: Is spleen removal necessary in all cases, or is the risk of lymph node metastases in the fat around the spleen low enough to reconsider this standard practice? Currently, spleen removal is part of the standard treatment for patients with left-sided pancreatic cancer to ensure that any potential lymph node metastases in the surrounding fat are also removed. However, the likelihood of metastases in this area is low, and spleen removal carries risks. This study is a first step toward changing the treatment approach. If the findings show that metastases in the fat around the spleen are rare, the next step will be a randomized trial to further investigate whether spleen removal is necessary.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatectomy | — | UNRESOLVED | — |
| Pancreatic Cancer Resectable | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Lymph node metastasis in spleen-part
- timeFrame
- 1 month
Secondary outcomes (14)
- measure
- Predictors for the occurrence of lymph node metastasis in the spleen-part
- timeFrame
- 1 month
- description
- A regression analysis will be performed to determine the predictors for the lymph node metastasis in the spleen part
- measure
- Overall and disease-free survival
- timeFrame
- 1 year, 2 years, 5 years
- description
- Overall survival was defined as the time interval from surgery to death from any cause, and disease-free survival was defined as the time between surgery to either recurrence or death from any cause. 1-year, 2-year, and 5-year survival rates will be determined. Also the cause of death will be described.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All consecutive adult patients (≥ 18 years) who undergo an open or minimally invasive (i.e., robot-assisted or laparoscopic) left-sided pancreatectomy with concomitant splenectomy for primary resectable, borderline resectable, and locally advanced left-sided PDAC Exclusion Criteria: * Tumor involvement or abutment of the spleen
References
Publications (1)
- BACKGROUNDBruna CL, van Hilst J, Esposito A, Kleive D, Falconi M, Primrose JN, Korrel M, Bianchi D, Zerbi A, Kokkola A, Butturini G, Bjornsson B, Morone M, Casadei R, Marudanayagam R, Besselink MG, Abu Hilal M; European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). The value of splenectomy during left-sided pancreatectomy for pancreatic ductal adenocarcinoma: predefined subanalysis in the DIPLOMA randomized trial. Br J Surg. 2024 Aug 30;111(9):znae236. doi: 10.1093/bjs/znae236. No abstract available. PMID 39287489