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RECRUITING
NCT07157605

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

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

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.

Official title: Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID): Study Protocol for a Prospective Observational International Multicenter Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

94

Start Date

2024-11-28

Completion Date

2031-01-01

Last Updated

2025-09-05

Healthy Volunteers

No

Locations (10)

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