Patient Reported Outcomes Measures to Predict Pancreatic Surgery Outcomes

NCT04431076 | Unknown

• 1 other identifier: PRO-PANC1
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Cancer; Patient Reported Outcome Measures; Quality of Life; Pancreatectomy; Nutritional Status; Recovery of Function

Keywords

Pancreatic cancer; Patient Reported Outcome Measures; Pancreatectomy

Outcome Measures

Primary Outcomes (3)

• Textbook outcome

  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.

  90 days after surgery

• Postoperative complications

  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

• Pancreatic fistula

  Occurrence of clinically-relevant postoperative pancreatic fistula defined as grade B or C POPF according to the 2016 International Study Group in Pancreatic Surgery (ISGPS) definition.

  90 days after surgery

Secondary Outcomes (4)

• Time to functional recovery

  90 days after surgery

• Generic health related quality of life measured by Patient Reported Outcome Measure Information System (PROMIS)-29+2 Profile version 2.1

  30 and 90 days after surgery

• Self reported physical activity - Duke Activity Status Index (DASI)

  30 and 90 days after surgery

• Return to preoperative exercise capacity

  30 days after surgery

Eligibility Criteria

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

Study Population

Consecutive patients planned for pancreatic resection will be enrolled and screened for physical, functional, nutritional and psychological risk factors. The study duration is 3 years, patients will be recruited for 24 months.

You may qualify if:

• All adult patients (age \> 18 years) with pancreatic, biliary or duodenal diseases planned for pancreatic resection at San Raffaele Hospital
• Signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massimo Falconi: lead

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Nicolò Pecorelli, Surgeon

  Ospedale San Raffaele IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 16, 2020
• Study Start: May 7, 2020
• Primary Completion: August 30, 2022
• Study Completion: June 30, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

IT (1)