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

Status: Recruiting
Location: See all (10) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
BenQ Hospital
RECRUITING
Nanjing
Greece
Konstantopoulio General Hospital
RECRUITING
Athens
Italy
Padova University Hospital
RECRUITING
Padua
Japan
Kyushu University Hospital
RECRUITING
Fukuoka
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
OLVG Hospital
RECRUITING
Amsterdam
Leiden University Medical Center
RECRUITING
Leiden
Norway
Oslo University Hospital
RECRUITING
Oslo
Spain
Dr. Peset University Hospital
RECRUITING
Valencia
Sweden
Linköping University Hospital
RECRUITING
Linköping
Contact Information
Primary
Jony van Hilst, MD, PhD
j.vanhilst@amsterdamumc.nl
0031617088813
Backup
Caro L Bruna, MD
c.l.bruna@amsterdamumc.nl
0031648515166
Time Frame
Start Date: 2024-11-28
Estimated Completion Date: 2031-01-01
Participants
Target number of participants: 94
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov