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.
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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Overall survival over a 3-year time period (3-year restricted mean survival time (RMST)) — Until 3-years after the day of surgery
Trial sites (1)
Facility
City
Region
Status
Amsterdam UMC
Amsterdam
Netherlands
More Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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