Status:
RECRUITING
Prehabilitation in Pancreatic Surgery
Lead Sponsor:
IRCCS San Raffaele
Collaborating Sponsors:
Ministero della Salute, Italy
Conditions:
Pancreatic Cancer
Periampullary Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal cancer, with 5-year survival around 10%. The combination of surgical resection and chemotherapy represents the most efficacious ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Indication for curative resection for pancreatic or periampullary cancer
- Signed Informed consent
Exclusion
- 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)
Key Trial Info
Start Date :
July 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT06069297
Start Date
July 14 2023
End Date
May 31 2027
Last Update
August 1 2025
Active Locations (1)
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1
San Raffaele Hospital
Milan, Lombardy, Italy, 20132