The value of splenectomy during left-sided pancreatectomy for pancreatic ductal adenocarcinoma: predefined subanalysis in the DIPLOMA randomized trial.
Caro L Bruna, Jony van Hilst, Alessandro Esposito...
https://pubmed.ncbi.nlm.nih.gov/39287489Actively Recruiting
Age: 18Years +
All Genders
ID07157605
Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID) Study Protocol for a Prospective Observational International Multicenter Study
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-09-05
94
Participants Needed
10
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how often lymph node metastases occur in the splenic hilum and surrounding fat in patients with left-sided pancreatic cancer. The study aims to find out whether spleen removal is always necessary during surgery or if the risk of metastases in the fat around the spleen is low enough to reconsider this standard practice. This observational study focuses on improving treatment decisions by gathering evidence to potentially change current surgical guidelines. The study will include patients undergoing left-sided pancreatectomy with spleen removal. After surgery, the removed tissue will be carefully examined to measure the rate of lymph node involvement around the spleen and pancreas. Oncological outcomes such as survival and recurrence will also be tracked. If lymph node involvement near the spleen is found to be less than 9%, researchers plan to move forward with a randomized trial to explore spleen preservation during surgery. Participants will be followed with detailed pathological assessments one month after surgery to measure metastasis rates and tumor characteristics. Additional outcomes will include survival rates and recurrence tracked up to five years. Postoperative complications and hospital stays will be recorded for 90 days. This prospective cohort study will provide valuable data on the safety and impact of spleen preservation in left-sided pancreatic cancer surgery over several years.
CONDITIONS
Brief Title
Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Undergoing open or minimally invasive left-sided pancreatectomy with spleen removal
- Diagnosed with primary resectable, borderline resectable, or locally advanced left-sided pancreatic ductal adenocarcinoma
You will not qualify if you...
- Tumor involving or abutting the spleen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Hospital stay plus 90 days post-surgery
Participants undergo a left-sided pancreatectomy with spleen removal followed by initial post-operative care.
Hospital stay with approximately 6 post-operative visits
Long-term Monitoring
Duration - Up to 5 years
Participants are monitored for overall and disease-free survival, recurrence, and other oncological outcomes.
Follow-up visits at 1 month, 1 year, 2 years, and 5 years
Trial Site Locations
Total: 10 locations
1
BenQ Hospital
Nanjing, China
Actively Recruiting
2
Konstantopoulio General Hospital
Athens, Greece
Actively Recruiting
3
Padova University Hospital
Padova, Italy
Actively Recruiting
4
Kyushu University Hospital
Fukuoka, Japan
Actively Recruiting
5
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
6
OLVG Hospital
Amsterdam, Netherlands
Actively Recruiting
7
Leiden University Medical Center
Leiden, Netherlands
Actively Recruiting
8
Oslo University Hospital
Oslo, Norway
Actively Recruiting
9
Dr. Peset University Hospital
Valencia, Spain
Actively Recruiting
10
Linköping University Hospital
Linköping, Sweden
Actively Recruiting
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Research Team
J
Jony van Hilst, MD, PhD
C
Caro L Bruna, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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