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Prehabilitation in Pancreatic Surgery

Study acronym: PIPS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 1, 2025 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jul 13, 2025 to May 31, 2026 Primary endpoints: 4 to 1 · Enrollment target: 226 to 238 · Completion date: Jul 13, 2026 to May 31, 2027 · 3 morev2 Show 6 more changesShow less
    • Primary endpoints: 4 to 1
    • Enrollment target: 226 to 238
    • Completion date: Jul 13, 2026 to May 31, 2027
    • Secondary endpoints: 6 to 12
    • Study description expanded, about 544 words
    • Collaborator revised

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In patients with pancreatic cancer, older age, multiple comorbidities, frailty, malnutrition and poor functional status are common, especially in individuals receiving neoadjuvant chemotherapy. These characteristics represent potentially modifiable risk factors for poor postoperative outcomes. The goal of this clinical randomized controlled trial is to evaluate the extent to which a four-week multimodal prehabilitation program impacts on postoperative morbidity, functional and nutritional status and health-related quality of life in patients with localized pancreatic or periampullary cancer scheduled for curative surgery. In addition, the impact of prehabilitation on circulating sarcopenia and cancer cachexia biomarkers in PDAC patients will be explored. Included patients will be randomized (ratio 1:1) and allocated either to the intervention group (Multimodal Prehabilitation), which will receive prehabilitation, or to the control group, which will receive no prehabilitation.
Trial Details
NCT Number NCT06069297
Lead Sponsor IRCCS San Raffaele
Collaborators: Ministero della Salute, Italy
Conditions Pancreatic Cancer, Periampullary Cancer, Frailty Syndrome, Malnutrition, Perioperative/Postoperative Complications
Enrollment 238 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov