Pancreatic CancerSPLENDID RCTNCT07799298
Spleen Preservation Versus Splenectomy in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID)
A study testing SPLP and LPS in people with Pancreatic Cancer and Pancreatectomy, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: During left pancreatectomy for pancreatic ductal adenocarcinoma (PDAC), routine en-bloc splenectomy is performed to achieve complete nodal clearance of the splenic hilum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatectomy, Adenocarcinoma Pancreas
- What is being tested?
- SPLP and LPS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2026to 1 Nov 2034
- Phase
- Interventional
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
Who may be able to join
- Age at least 18 years;
- Elective indication for left pancreatectomy for proven or suspected PDAC;
- Upfront resectable or borderline-resectable PDAC in the pancreatic neck, body or tail, according to the National Comprehensive Cancer Network® (NCCN®);
- o Patients receiving neo-adjuvant treatment can be included in the trial, if the tumor was upfront resectable or borderline-resectable before the start of neoadjuvant therapy. Patients receiving induction therapy for locally advanced pancreatic cancer (LAPC) will be excluded.
- Spleen preservation using SPLP with the Warshaw (splenic vessel-resecting) procedure including Gerota's fascia (i.e. circumferentially radical) is feasible according to the local treatment team;
- Fit to undergo left pancreatectomy according to the surgeon and anesthesiologist;
- Written informed consent.
Who cannot join
- Preoperative imaging indicating (possible) tumor involvement of the perisplenic LNs (LN station 10 and perisplenic fat);
- Distance between the left border of the tumor and the center of the splenic hilum is <3cm on preoperative imaging;
- Locally advanced PDAC according to the NCCN definition or distant metastasis;
- Previous abdominal surgery in which the short gastric and/or left gastroepiploic vessels were ligated (e.g. gastrectomy, gastric sleeve, fundoplication), resulting in the impossibility of performing a Warshaw (spleen-vessel resecting) procedure;
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Charlotte Baggerman van Houweninge, MD contact
About this study
Official title: Spleen Preservation Versus Splenectomy in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID): an International Randomized Controlled Trial
Rationale: During left pancreatectomy for pancreatic ductal adenocarcinoma (PDAC), routine en-bloc splenectomy is performed to achieve complete nodal clearance of the splenic hilum. However, evidence that splenectomy improves survival is lacking, while splenectomy may increase postoperative morbidity and has lifelong consequences related to loss of splenic function. Spleen-preserving left pancreatectomy (SPLP) may be a safe alternative, but high-quality evidence is lacking.
Objective: To compare SPLP with left pancreatectomy with splenectomy (LPS) regarding overall survival and major postoperative morbidity in patients with resectable or borderline resectable PDAC.
Read more
Study design: An international, randomized, controlled, multicenter, non-inferiority trial.
Study population: Two groups of 180 patients (360 in total) with proven or suspected resectable or borderline resectable PDAC requiring left pancreatectomy.
Intervention: Spleen-preserving left pancreatectomy (SPLP)
Control: Left pancreatectomy with splenectomy (LPS)
Read the detailed description
Rationale: During left pancreatectomy for pancreatic ductal adenocarcinoma (PDAC), routine en-bloc splenectomy is performed to achieve complete nodal clearance of the splenic hilum. However, there is no evidence that routine splenectomy improves survival. Splenectomy has been associated with increased postoperative morbidity, lifelong vaccination requirements, and risk of overwhelming post-splenectomy infection. In addition, lymph node metastases in the splenic hilum are uncommon (~4%), and preservation of splenic immune function is becoming increasingly important with the emergence of novel immunotherapies. Spleen-preserving left pancreatectomy (SPLP) may therefore be a safe alternative to routine splenectomy, but no randomized trials have evaluated this approach.
Objective: To compare SPLP with left pancreatectomy with splenectomy (LPS) regarding (1) overall survival over a 3-year period, assessed using restricted mean survival time (RMST), and (2) major postoperative complications within 90 days (Clavien-Dindo grade III or higher) in patients with resectable or borderline resectable PDAC.
Study design: An international randomized multicenter non-inferiority trial performed in high-volume pancreatic centers. Participating centers perform at least 15 left pancreatectomies annually, and participating surgeons have completed at least 30 SPLPs (for any indication) and 15 left pancreatectomies for PDAC. Randomization will be performed in a 1:1 ratio using a secure web-based system, stratified for receipt of neoadjuvant therapy (yes/no) and tumor location (body/neck versus tail).
Study population: Two groups of 180 patients (360 in total) with proven or suspected resectable or borderline resectable PDAC requiring left pancreatectomy.
Intervention: Spleen-preserving left pancreatectomy.
Control: Left pancreatectomy with splenectomy.
Main study parameters/endpoints: The primary endpoint is overall survival over a 3-year period, assessed using RMST. The main secondary endpoint is major postoperative morbidity within 90 days (Clavien-Dindo grade III or higher). Other secondary outcomes include quality of life, R0 resection rate, disease-free survival, time to and site of recurrence, receipt, timing and completion of adjuvant therapy, pancreas-specific and general postoperative complications, unplanned splenectomy in the SPLP group, secondary splenectomy, spleen- and asplenia-related complications, time to functional recovery, length of hospital stay, health-care resource utilization, and cost-effectiveness.
- Conditions
- Pancreatic Cancer, Pancreatectomy, Adenocarcinoma Pancreas
- Being tested
- SPLP, LPS
- Keywords
- Left pancreatectomy, Pancreatic Cancer, Spleen-preservation, Warshaw procedure, Splenectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPLPProcedure or surgery
Spleen-preserving Left Pancreatectomy
LPSProcedure or surgery
Left Pancreatectomy with Splenectomy
| Study group | Role | What they receive |
|---|---|---|
| Spleen-preservation | Experimental | Not described Receives: Procedure: SPLP |
| Splenectomy | Active comparator | Not described Receives: Procedure: LPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival over a 3-year time period (3-year restricted mean survival time (RMST))
Measured: Until 3-years after the day of surgery
Secondary outcomes (1)
90-day major postoperative complications
Clavien-Dindo classification grade ≥3
Measured: From the day of surgery until 90-days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2032 (estimated)
- Study completion1 Nov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- 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 UMCMarc G. Besselink, MD, PhD, Principal investigator, Amsterdam UMCMohammad Abu Hilal, MD, PhD, Principal investigator, Jordan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799298
- Sponsor's protocol ID
- NL.012057
- Acronym
- SPLENDID RCT
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided