RecruitingNCT07157605

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


Sponsor

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

Enrollment

94 participants

Start Date

Nov 28, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • 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 Criteria1

  • Tumor involvement or abutment of the spleen

Locations(10)

BenQ Hospital

Nanjing, China

Konstantopoulio General Hospital

Athens, Greece

Padova University Hospital

Padua, 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

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NCT07157605


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