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)
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®);
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;
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;
Parallel
SPLP
Procedure/SurgerySpleen-preserving Left Pancreatectomy
LPS
Procedure/SurgeryLeft Pancreatectomy with Splenectomy
Overall survival over a 3-year time period (3-year restricted mean survival time (RMST))
90-day major postoperative complications
Clavien-Dindo classification grade ≥3
Intraoperative outcomes
\- Diagnostic laparoscopy performed (yes vs no);
Complications
* Postoperative pancreatic fistula (grade B/C); * Post-pancreatectomy hemorrhage (grade B/C); * Delayed gastric emptying (grade B/C); * Post-pancreatectomy acute pancreatitis (grade B/C); * Chyle leak (grade B/C); All reported according to the ISGPS definitions
Pathological outcomes
\- Tumor size; mm
Oncological outcomes
* (Neo-)adjuvant treatment; yes/no * Recurrence: yes/no * Treatment of recurrence: yes/no
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