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

NCT07799298 | Not Yet Recruiting DMC

• 1 other identifier: NL.012057
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Pancreatic Cancer; Pancreatectomy; Adenocarcinoma Pancreas

Keywords

Left pancreatectomy; Pancreatic Cancer; Spleen-preservation; Warshaw procedure; Splenectomy

Outcome Measures

Primary Outcomes (1)

• Overall survival over a 3-year time period (3-year restricted mean survival time (RMST))

  Until 3-years after the day of surgery

Secondary Outcomes (1)

• 90-day major postoperative complications

  From the day of surgery until 90-days postoperative

Other Outcomes (24)

• Intraoperative outcomes

  Day of operation

• Complications

  Day of surgery until 90-days postoperative

• Pathological outcomes

  When pathology report available postoperative

Study Arms (2)

Spleen-preservation

EXPERIMENTAL

Procedure: SPLP

Splenectomy

ACTIVE COMPARATOR

Procedure: LPS

Interventions

SPLP PROCEDURE

Spleen-preserving Left Pancreatectomy

Spleen-preservation

LPS PROCEDURE

Left Pancreatectomy with Splenectomy

Splenectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Jony van Hilst, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

• Marc G. Besselink, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

• Mohammad Abu Hilal, MD, PhD

  Jordan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Baggerman van Houweninge, MD

CONTACT

031 020 444 4444; c.e.baggermanvanhouweninge@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. M.G. Besselink

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: September 2, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): November 1, 2034
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

NL (1)