Pancreatic Cancer ResectableSPLENDIDNCT07157605
Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID)
An observational study of Pancreatic Cancer Resectable and Pancreatectomy, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 10 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer Resectable, Pancreatectomy
- How many people
- 94 participants
- Where
- 10 sitesin 8 countries
- Study dates
- 28 Nov 2024to 1 Jan 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from hospitals performing pancreatic surgery
Who may be able to join
- 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
Who cannot join
- Tumor involvement or abutment of the spleen
Trial locations and contacts
10 sites in 8 countries.
10 sites in 8 countries
Netherlands3 sites
Amsterdam UMC
Amsterdam
OLVG Hospital
Amsterdam
Leiden University Medical Center
Leiden
About this study
Official title: Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID): Study Protocol for a Prospective Observational International Multicenter Study
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:
Read more
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.
Read the detailed description
Splenectomy is routinely performed during surgical resection of left-sided pancreatic ductal adenocarcinoma (PDAC) with the primary aim to facilitate adequate lymphadenectomy. However, asplenia is associated with several risks, including overwhelming post-splenectomy sepsis, and an increased risk of the development of cancer. Until several years ago, splenectomy was also routine practice in the surgical treatment of gastric cancer. Recently, several studies have shown that spleen-preservation in patients with gastric cancer is safe and therefore current guidelines advise against splenectomy. The rate of involved lymph nodes (LNs) in the splenic hilum (LN station 10) described in literature differs from 0 to 10% of patients. In these studies, the definition of the splenic hilum is often unclear and therefore these outcomes are difficult to interpret. Spleen-preservation in left-sided pancreatectomy for PDAC is currently not common practice in The Netherlands and goes against treatment guidelines. Two retrospective studies have suggested that spleenpreservation did not impair oncological outcomes and that postoperative complications occurred less after spleen preservation. However, these studies were retrospective, single-center and only included a very small number of patients and are therefore not providing enough evidence to change current practice. The SPLENDID-project focuses on evaluating the oncological safety of spleen-preservation in patients with left-sided PDAC. A prospective cohort study will be performed including all patients who undergo a left-sided pancreatectomy with splenectomy. The specimens will be transected at the precise level were spleen preservation (with resection of splenic vessels) would be performed (after removal of the specimen). Ratio of LN involvement will be collected for both specimen parts. Additionally, oncological patient outcomes, including survival, will be collected. When the pathological assessment confirms a <9% LN involvement rate in the perihilar space, the next step will be to assess spleen preservation in an international, multicenter randomized controlled trial.
- Conditions
- Pancreatic Cancer Resectable, Pancreatectomy
- Keywords
- pancreatic adenocarcinoma, PDAC, left pancreatectomy, distal pancreatectomy, splenectomy, splenic hilum
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph node metastasis in spleen-part
Measured: 1 month
Secondary outcomes (14)
Predictors for the occurrence of lymph node metastasis in the spleen-part
A regression analysis will be performed to determine the predictors for the lymph node metastasis in the spleen part
Measured: 1 month
Overall and disease-free survival
Overall survival was defined as the time interval from surgery to death from any cause, and disease-free survival was defined as the time between surgery to either recurrence or death from any cause. 1-year, 2-year, and 5-year survival rates will be determined. Also the cause of death will be described.
Measured: 1 year, 2 years, 5 years
Predictors for overall and disease-free survival
A multivariable regression analysis will determine independent prognostic factors for overall and disease-free survival (including whether lymph node metastases in the spleen part are an independent prognostic factor).
Measured: 1-year, 2-year, and 5-year
Recurrence
Measured: 1 year, 2 years, 5 years
Recurrence-free survival
defined as the interval between surgery and recurrence, will be determined.
Measured: 1 year, 2 years, 5 years
Lymph node metastasis (in pancreas-part and overall)
in pathological assessment
Measured: 1 month
Identification of left gastroepiploic vessels in spleen-part
in pathological assessment
Measured: 1 month
Identification of pancreatic tissue in spleen-part
in pathological assessment
Measured: 1 month
Distance from transection plane to tumor
in pathological assessement
Measured: 1 month
Tumor deposits
in pathological assessment
Measured: 1 month
Radical (R0) resection rate
in pathological assessment
Measured: 1 month
Histopathological diagnosis
in pathological assessment
Measured: 1 month
Postoperative complications
Measured: 90 days
Length of hospital stay
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start28 Nov 2024
- Primary completion1 Jan 2026
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Cancer ResectableStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.G. Besselink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jony van Hilst, MD, PhD, Principal investigator, Amsterdam UMC, location University of Amsterdam, Department of Surgery, Amsterdam, The NetherlandsMarc G Besselink, MD, PhD, professor, Principal investigator, Amsterdam UMC, location University of Amsterdam, Department of Surgery, Amsterdam, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157605
- Sponsor's protocol ID
- 2024.0713
- Acronym
- SPLENDID
- Status last verified
- Jul 2026
- First submitted
- 2 Apr 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39287489
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID): Study Protocol for a Prospective Observational International Multicenter Study
- ClinicalTrials.gov ID
- NCT07157605
- Acronym / sponsor ID
- SPLENDID / 2024.0713
- Conditions
- Pancreatic Cancer Resectable, Pancreatectomy
- Keywords
- pancreatic adenocarcinoma, PDAC, left pancreatectomy, distal pancreatectomy, splenectomy, splenic hilum
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Splenectomy is routinely performed during surgical resection of left-sided pancreatic ductal adenocarcinoma (PDAC) with the primary aim to facilitate adequate lymphadenectomy. However, asplenia is associated with several risks, including overwhelming post-splenectomy sepsis, and an increased risk of the development of cancer. Until several years ago, splenectomy was also routine practice in the surgical treatment of gastric cancer. Recently, several studies have shown that spleen-preservation in patients with gastric cancer is safe and therefore current guidelines advise against splenectomy. The rate of involved lymph nodes (LNs) in the splenic hilum (LN station 10) described in literature differs from 0 to 10% of patients. In these studies, the definition of the splenic hilum is often unclear and therefore these outcomes are difficult to interpret. Spleen-preservation in left-sided pancreatectomy for PDAC is currently not common practice in The Netherlands and goes against treatment guidelines. Two retrospective studies have suggested that spleenpreservation did not impair oncological outcomes and that postoperative complications occurred less after spleen preservation. However, these studies were retrospective, single-center and only included a very small number of patients and are therefore not providing enough evidence to change current practice. The SPLENDID-project focuses on evaluating the oncological safety of spleen-preservation in patients with left-sided PDAC. A prospective cohort study will be performed including all patients who undergo a left-sided pancreatectomy with splenectomy. The specimens will be transected at the precise level were spleen preservation (with resection of splenic vessels) would be performed (after removal of the specimen). Ratio of LN involvement will be collected for both specimen parts. Additionally, oncological patient outcomes, including survival, will be collected. When the pathological assessment confirms a <9% LN involvement rate in the perihilar space, the next step will be to assess spleen preservation in an international, multicenter randomized controlled trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from hospitals performing pancreatic surgery
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Tumor involvement or abutment of the spleen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lymph node metastasis in spleen-part
Time frame: 1 month
14 secondary outcomes
Predictors for the occurrence of lymph node metastasis in the spleen-part
Time frame: 1 month
Overall and disease-free survival
Time frame: 1 year, 2 years, 5 years
Predictors for overall and disease-free survival
Time frame: 1-year, 2-year, and 5-year
Recurrence
Time frame: 1 year, 2 years, 5 years
Recurrence-free survival
Time frame: 1 year, 2 years, 5 years
Lymph node metastasis (in pancreas-part and overall)
Time frame: 1 month
Identification of left gastroepiploic vessels in spleen-part
Time frame: 1 month
Identification of pancreatic tissue in spleen-part
Time frame: 1 month
Distance from transection plane to tumor
Time frame: 1 month
Tumor deposits
Time frame: 1 month
Radical (R0) resection rate
Time frame: 1 month
Histopathological diagnosis
Time frame: 1 month
Postoperative complications
Time frame: 90 days
Length of hospital stay
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 39287489Bruna 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.
- Dutch Pancreatic Cancer GroupLink provided by the sponsor.
- E-MIPS consortium (English)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jony van Hilst, MD, PhD principal investigator
Amsterdam UMC, location University of Amsterdam, Department of Surgery, Amsterdam, The Netherlands
Marc G Besselink, MD, PhD, professor principal investigator
Amsterdam UMC, location University of Amsterdam, Department of Surgery, Amsterdam, The Netherlands
10 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer Resectable and Pancreatectomy, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 10 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands, China, Greece, Italy, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymph node metastasis in spleen-part (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07157605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.