Prehabilitation in Pancreatic Surgery

NCT06069297 | Recruiting DMC

• 1 other identifier: GR-2021-12374985
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer; Periampullary Cancer; Frailty Syndrome; Malnutrition; Perioperative/Postoperative Complications

Keywords

Prehabilitation; Physical function; Nutritional status; Functional capacity; Pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Comprehensive Complication Index (CCI)

  Postoperative complications occurring during the index admission or in a subsequent readmission, when related to surgery, will be recorded up to 90 days after surgery and graded by severity using the Dindo-Clavien classification and the Comprehensive Complication index (CCI). The Dindo-Clavien system grades complications according to the therapy needed for treatment: Grade I, are complications that require bedside management; Grade II, are complications that require pharmacologic treatment; Grade III, are complications that require surgical or radiologic intervention and; Grade IV, are complications that require intensive care treatment. Dindo-Clavien Grade III or above are considered severe postoperative complications. The CCI, derived from the Dindo-Clavien system, is a validated metric summarizing the complete spectrum of complications that occurred and their severity in a single score ranging from 0 to 100.

  90 days after surgery

Secondary Outcomes (12)

• Time to patient functional recovery (TFR)

  90 days after surgery

• Lenght of stay (LOS)

  90 days after surgery

• Functional capacity

  One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery

• Nutritional status

  One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery.

• Bioimpedance analysis (BIA) derived body composition

  One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery

Other Outcomes (1)

• Hospital costs

  90 days after surgery

Study Arms (2)

Multimodal Prehabilitation

EXPERIMENTAL

The intervention consists of a supervised multimodal prehabilitation program (exercise, nutritional support, and psychosocial counseling) conducted for a minimum of four weeks prior to surgery, during the waiting time following patient enrolment.

Other: Multimodal Prehabilitation

Usual care

NO INTERVENTION

Usual preoperative care. Patients in the control group will be treated according to usual care and will be given informative material regarding a healthy lifestyle and how to best prepare for surgery.

Interventions

Multimodal Prehabilitation OTHER

Preoperative multimodal intervention including exercise training, nutritional therapy and psychosocial counseling, aimed at preventing or attenuating surgery-driven functional decline. A personalized intervention program will be prescribed based on specific physical, nutritional and psychological conditions recognized during the multimodal assessment. Patients will follow a 2 to 3-day per week exercise program for 4-6 weeks including endurance, resistance, and inspiratory muscle training, tailored to individual preferences and clinical conditions. Based on dietary habits and nutritional status, a certified nutritionist will provide a comprehensive diet management program. A food-based intervention with a balanced macronutrient composition coupled with oral nutritional supplements will be prescribed to achieve the estimated daily energy and protein requirements. Patients will meet with a psychologist to explore their emotional and psychosocial needs related to their current situation.

Multimodal Prehabilitation

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Indication for curative resection for pancreatic or periampullary cancer
• Signed Informed consent

You may not qualify if:

• Metastatic or unresectable disease found preoperatively
• Comorbidities contraindicating prehabilitation regimen (exercise and nutritional intervention) such as orthopedic, cognitive disabilities, chronic renal failure (dialysis or creatinine \>250 mmol)
• ASA score 4-5
• Pregnancy
• Illiteracy (inability to read and understand Italian language)

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Ministero della Salute, Italy: collaborator

Study Sites (1)

San Raffaele Hospital

Milan, Lombardy, 20132, Italy

RECRUITING

Related Publications (4)

• Mizrahi JD, Surana R, Valle JW, Shroff RT. Pancreatic cancer. Lancet. 2020 Jun 27;395(10242):2008-2020. doi: 10.1016/S0140-6736(20)30974-0.

  PMID: 32593337 BACKGROUND

• Lambert JE, Hayes LD, Keegan TJ, Subar DA, Gaffney CJ. The Impact of Prehabilitation on Patient Outcomes in Hepatobiliary, Colorectal, and Upper Gastrointestinal Cancer Surgery: A PRISMA-Accordant Meta-analysis. Ann Surg. 2021 Jul 1;274(1):70-77. doi: 10.1097/SLA.0000000000004527.

  PMID: 33201129 BACKGROUND

• Pecorelli N, Guarneri G, Vallorani A, Limongi C, Licinio AW, Di Salvo F, Tamburrino D, Partelli S, Crippa S, Falconi M. Validation of the PROMIS-29 Questionnaire as a Measure of Recovery After Pancreatic Surgery. Ann Surg. 2023 Nov 1;278(5):732-739. doi: 10.1097/SLA.0000000000006020. Epub 2023 Jul 19.

  PMID: 37465965 BACKGROUND

• Pecorelli N, Fermi F, Abati M, Bonomi B, Fossati L, Corti G, Guarneri G, Macchini M, Damascelli A, Palumbo D, Gaviraghi S, Di Mattei V, De Cobelli F, Tettamanti A, Falconi M. Multimodal Prehabilitation In Pancreatic cancer Patients undergoing surgery (PIPS): study protocol for a randomized controlled trial. Trials. 2026 Jan 31. doi: 10.1186/s13063-026-09467-z. Online ahead of print.

  PMID: 41618415 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Frailty; Malnutrition; Postoperative Complications

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Massimo Falconi, MD

  San Raffaele Hospital

  STUDY CHAIR

Central Study Contacts

Nicolò Pecorelli, MD

CONTACT

+390226432111; pecorelli.nicolo@hsr.it

Francesca Di Salvo, PhD

CONTACT

+390226436046; disalvo.francesca@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The trial is designed as a randomized, controlled, assessor-blind trial. Patient and investigator blinding will not be feasible due to the nature of the intervention and the direct involvement of the prehabilitation team. However, to minimize potential blinding and performance biases, enrolled patients will be informed that we will compare two types of strategies (prehabilitation and usual care), both aiming at improving their health conditions and fitness before surgery, and neither will be presented as potentially superior.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Enrolled patients will be randomized (ratio 1:1) and allocated either to the intervention group (Multimodal Prehabilitation) or to the usual care group

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: October 5, 2023
• Study Start: July 14, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

IT (1)