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

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID
NCT07799298
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SPLP — PROCEDURE
    Spleen-preserving Left Pancreatectomy
  • LPS — PROCEDURE
    Left Pancreatectomy with Splenectomy

Study Details

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)

Key Dates

First listed
Sep 2, 2026
Start date
Nov 1, 2026
Status verified
Aug 2026
Primary completion
Nov 1, 2032
Completion
Nov 1, 2034

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Spleen-preservation
  • Active Comparator: Splenectomy

Primary Outcome Measure

Overall survival over a 3-year time period (3-year restricted mean survival time (RMST)) [ Time Frame: Until 3-years after the day of surgery ]

Central Contacts

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