Keeping the spleen during left-sided pancreatic cancer surgery
Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID): Study Protocol for a Prospective Observational International Multicenter Study
This observational study will test whether keeping the spleen during left-sided pancreatic cancer surgery is safe by checking for cancer spread to lymph nodes at the splenic hilum in adults having a left pancreatectomy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 94 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 10 sites (Nanjing and 9 other locations) |
| Trial ID | NCT07157605 on ClinicalTrials.gov |
What this trial studies
This multicenter observational project collects data from adults who undergo open or minimally invasive left-sided pancreatectomy with planned splenectomy for pancreatic ductal adenocarcinoma to determine how often lymph node metastases occur in the splenic hilum and surrounding fat. Pathology of the splenic hilum and perisplenic fat will be reviewed to quantify the frequency of nodal involvement in that region. Patients with tumor invasion or abutment of the spleen are excluded to focus on cases where spleen preservation might be technically feasible. These results will inform whether a randomized trial testing spleen preservation versus routine splenectomy is justified.
Who should consider this trial
Good fit: Adults (≥18) undergoing open or minimally invasive left-sided pancreatectomy with concomitant splenectomy for primary resectable, borderline resectable, or locally advanced pancreatic ductal adenocarcinoma without tumor involvement of the spleen.
Not a fit: Patients whose tumor directly involves or abuts the spleen, those with non-PDAC diagnoses, or patients not undergoing splenectomy are unlikely to benefit from the study's findings.
Why it matters
Potential benefit: If keeping the spleen is shown to be safe, patients could avoid spleen removal and its associated risks such as overwhelming post-splenectomy infections and possibly reduced postoperative complications.
How similar studies have performed: Small retrospective single-center series and evidence from gastric cancer surgery suggest spleen preservation can be safe, but data specific to PDAC are limited and not definitive.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nanjing and 9 other locations
- BenQ Hospital — Nanjing, China (Recruiting)
- Konstantopoulio General Hospital — Athens, Greece (Recruiting)
- Padova University Hospital — Padova, Italy (Recruiting)
- Kyushu University Hospital — Fukuoka, Japan (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- OLVG Hospital — Amsterdam, Netherlands (Recruiting)
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- Dr. Peset University Hospital — Valencia, Spain (Recruiting)
- Linköping University Hospital — Linköping, Sweden (Recruiting)
Study contacts
- Principal investigator: Jony van Hilst, MD, PhD — Amsterdam UMC, location University of Amsterdam, Department of Surgery, Amsterdam, The Netherlands
- Study coordinator: Jony van Hilst, MD, PhD
- Email: j.vanhilst@amsterdamumc.nl
- Phone: 0031617088813
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.