Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID)

NCT07157605 | Recruiting

• 1 other identifier: 2024.0713
• Study Type: observational
• Target: 94
• Locations: 8 countries
• Sites: 10

Brief 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.

Conditions

Pancreatic Cancer Resectable; Pancreatectomy

Keywords

pancreatic adenocarcinoma; PDAC; left pancreatectomy; distal pancreatectomy; splenectomy; splenic hilum

Outcome Measures

Primary Outcomes (1)

• Lymph node metastasis in spleen-part

  1 month

Secondary Outcomes (14)

• Predictors for the occurrence of lymph node metastasis in the spleen-part

  1 month

• Overall and disease-free survival

  1 year, 2 years, 5 years

• Predictors for overall and disease-free survival

  1-year, 2-year, and 5-year

• Recurrence

  1 year, 2 years, 5 years

• Recurrence-free survival

  1 year, 2 years, 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from hospitals performing pancreatic surgery

You may qualify if:

• 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

You may not qualify if:

• Tumor involvement or abutment of the spleen

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (10)

BenQ Hospital

Nanjing, China

RECRUITING

Konstantopoulio General Hospital

Athens, Greece

RECRUITING

Padova University Hospital

Padua, 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

Related Publications (1)

• Bruna CL, van Hilst J, Esposito A, Kleive D, Falconi M, Primrose JN, Korrel M, Bianchi D, Zerbi A, Kokkola A, Butturini G, Bjornsson B, Morone M, Casadei R, Marudanayagam R, Besselink MG, Abu Hilal M; European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). The value of splenectomy during left-sided pancreatectomy for pancreatic ductal adenocarcinoma: predefined subanalysis in the DIPLOMA randomized trial. Br J Surg. 2024 Aug 30;111(9):znae236. doi: 10.1093/bjs/znae236. No abstract available.

  PMID: 39287489 BACKGROUND

Related Links

• Dutch Pancreatic Cancer Group
• E-MIPS consortium (English)

Study Officials

• Jony van Hilst, MD, PhD

  Amsterdam UMC, location University of Amsterdam, Department of Surgery, Amsterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

• Marc G Besselink, MD, PhD, professor

  Amsterdam UMC, location University of Amsterdam, Department of Surgery, Amsterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jony van Hilst, MD, PhD

CONTACT

0031617088813; j.vanhilst@amsterdamumc.nl

Caro L Bruna, MD

CONTACT

0031648515166; c.l.bruna@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: September 5, 2025
• Study Start: November 28, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2031
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

GR (1); NO (1); IT (1); NL (3); CN (1); SE (1); JP (1); ES (1)