An observational study in Pancreatic Cancer Resectable and Pancreatectomy, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Active, not recruiting at 10 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational
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.
Splenectomy is routinely performed during surgical resection of left-sided pancreatic ductal adenocarcinoma (PDAC) with the primary aim to facilitate adequate lymphadenectomy. However, asplenia is associated with several risks, including overwhelming post-splenectomy sepsis, and an increased risk of the development of cancer. Until several years ago, splenectomy was also routine practice in the surgical treatment of gastric cancer. Recently, several studies have shown that spleen-preservation in patients with gastric cancer is safe and therefore current guidelines advise against splenectomy. The rate of involved lymph nodes (LNs) in the splenic hilum (LN station 10) described in literature differs from 0 to 10% of patients. In these studies, the definition of the splenic hilum is often unclear and therefore these outcomes are difficult to interpret. Spleen-preservation in left-sided pancreatectomy for PDAC is currently not common practice in The Netherlands and goes against treatment guidelines. Two retrospective studies have suggested that spleenpreservation did not impair oncological outcomes and that postoperative complications occurred less after spleen preservation. However, these studies were retrospective, single-center and only included a very small number of patients and are therefore not providing enough evidence to change current practice. The SPLENDID-project focuses on evaluating the oncological safety of spleen-preservation in patients with left-sided PDAC. A prospective cohort study will be performed including all patients who undergo a left-sided pancreatectomy with splenectomy. The specimens will be transected at the precise level were spleen preservation (with resection of splenic vessels) would be performed (after removal of the specimen). Ratio of LN involvement will be collected for both specimen parts. Additionally, oncological patient outcomes, including survival, will be collected. When the pathological assessment confirms a \<9% LN involvement rate in the perihilar space, the next step will be to assess spleen preservation in an international, multicenter randomized controlled trial.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients from hospitals performing pancreatic surgery
Exclusion Criteria:
Lymph node metastasis in spleen-part
Time frame: 1 month
Predictors for the occurrence of lymph node metastasis in the spleen-part
A regression analysis will be performed to determine the predictors for the lymph node metastasis in the spleen part
Time frame: 1 month
Overall and disease-free survival
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.
Time frame: 1 year, 2 years, 5 years
Predictors for overall and disease-free survival
A multivariable regression analysis will determine independent prognostic factors for overall and disease-free survival (including whether lymph node metastases in the spleen part are an independent prognostic factor).
Time frame: 1-year, 2-year, and 5-year
Recurrence
Time frame: 1 year, 2 years, 5 years
Recurrence-free survival
defined as the interval between surgery and recurrence, will be determined.
Time frame: 1 year, 2 years, 5 years
Lymph node metastasis (in pancreas-part and overall)
in pathological assessment
Time frame: 1 month
Identification of left gastroepiploic vessels in spleen-part
in pathological assessment
Time frame: 1 month
Identification of pancreatic tissue in spleen-part
in pathological assessment
Time frame: 1 month
Distance from transection plane to tumor
in pathological assessement
Time frame: 1 month
Tumor deposits
in pathological assessment
Time frame: 1 month
Radical (R0) resection rate
in pathological assessment
Time frame: 1 month
Histopathological diagnosis
in pathological assessment
Time frame: 1 month
Postoperative complications
Time frame: 90 days
Length of hospital stay
Time frame: 90 days
Plan to share: Undecided
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)