Spleen Preservation Versus Splenectomy in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID)

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. 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)

Interventions

• SPLP · PROCEDURE

  Spleen-preserving Left Pancreatectomy

• LPS · PROCEDURE

  Left Pancreatectomy with Splenectomy

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (1)

• Amsterdam UMC, Amsterdam, Netherlands