Clinical trial · Observational
Patient Reported Outcomes Measures to Predict Pancreatic Surgery Outcomes
The PRO-PANC1 Project: Patient Reported Outcomes Measures to Predict Pancreatic Surgery Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective single-center observational study with the mail objective to identify specific subgroups of patients planned for pancreatic resection, at high risk for postoperative morbidity and impaired recovery through preoperative screening of physical, functional, nutritional and psychological risk factors using patient reported questionnaires and performance tests. Consecutive patients planned for pancreatic resection will be enrolled to screen for physical, functional, nutritional and psychological risk factors. The study duration is 3 years: 2 years of recruitment and 1 year of follow-up. The findings of the present study will enable researchers to identify specific risk categories to plan personalized prehabilitation programs and modulate oncologic treatment strategies in cancer patients planned for pancreatic surgery.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nutritional Status | — | UNRESOLVED | — |
| Pancreatectomy | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Patient Reported Outcome Measures | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Recovery of Function | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Textbook outcome
- timeFrame
- 90 days after surgery
- description
- Textbook outcome (TO) is a multidimensional measure for quality assurance, reflecting the "ideal" surgical outcome. TO is defined by the absence of clinically-relevant postoperative pancreatic fistula, bile leak, postpancreatectomy hemorrhage, severe complications (Clavien-Dindo ≥III) including mortality, and readmission. The primary outcome will be the failure to achieve a textbook outcome.
- measure
- Postoperative complications
- timeFrame
- 90 days after surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All adult patients (age \> 18 years) with pancreatic, biliary or duodenal diseases planned for pancreatic resection at San Raffaele Hospital * Signed informed consent Exclusion Criteria: * Patients with American Society of Anesthesiologists (ASA) health status class 4-5. * Patients with co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis), cardiac abnormalities, severe end-organ disease such as cardiac failure, morbid obesity (BMI \>40), anemia (hematocrit \< 30 %) and other conditions interfering with the ability to complete the performance testing procedures. * Inability to read or understand Italian.
References
Publications (0)
Data not yet available