Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID)
NCT07157605 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 94
Last updated 2025-09-05
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.
Conditions
- Pancreatic Cancer Resectable
- Pancreatectomy
Sponsors & Collaborators
-
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
lead OTHER
Principal Investigators
-
Jony van Hilst, MD, PhD · Amsterdam UMC, location University of Amsterdam, Department of Surgery, Amsterdam, The Netherlands
-
Marc G Besselink, MD, PhD, professor · Amsterdam UMC, location University of Amsterdam, Department of Surgery, Amsterdam, The Netherlands
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-28
- Primary Completion
- 2026-01-01
- Completion
- 2031-01-01
Countries
- China
- Greece
- Italy
- Japan
- Netherlands
- Norway
- Spain
- Sweden
Study Locations
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