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Clinical Trials in Spain / NCT07157605
Active, not recruiting Observational

Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID)

NCT07157605 · tracked via the Priya Life Science Spain tracker
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase
Observational
Started
2024-11-28
Last updated
2026-07-22

Condition(s) studied

Pancreatic Cancer ResectablePancreatectomy

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Lymph node metastasis in spleen-part — 1 month

Trial sites (10)

FacilityCityRegionStatus
BenQ Hospital Nanjing China
Konstantopoulio General Hospital Athens Greece
Padova University Hospital Padova Italy
Kyushu University Hospital Fukuoka Japan
Amsterdam UMC Amsterdam Netherlands
OLVG Hospital Amsterdam Netherlands
Leiden University Medical Center Leiden Netherlands
Oslo University Hospital Oslo Norway
Dr. Peset University Hospital Valencia Spain
Linköping University Hospital Linköping Sweden

More Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) trials in Spain

Timing of Comprehensive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma Recruiting
European Multicenter Validation of PCaVision: A Head-to-Head Diagnostic Accuracy Study Comparing Multiparametric Transrectal Ultrasound to MRI for Clinically Significant Prostate Cancer Detection Active, not recruiting
Distribution of Lymph Node Metastases in Esophageal Carcinoma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07157605 on ClinicalTrials.gov ↗ ← All trials in Spain