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Active Not Recruiting
NCT07157605
Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID)
Conditions: Pancreatic Cancer Resectable, Pancreatectomy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 94
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Location: BenQ Hospital Nanjing
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 Criteria
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
Source: ClinicalTrials.gov (NCT07157605). StuddyBuddy aggregates publicly available trial information.