Covid-19 Pandemic and Pancreatic Surgery in Italy

Study Overview
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Brief Summary
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Pancreatic cancer (PC) is recognized as one of the most challenging tumors to deal with and it is still characterized by a poor long-term prognosis. However, treatment of PC in high-volume centers with the support of a multidisciplinary approach has widely demonstrated improvement both in terms of short- and long-term outcomes. The recent worldwide spread of Covid-19 pandemic significantly affected the healthcare systems of most countries in the world, particularly in red areas such as Italy, with more than 100.000 cases in a two-month time lapse. This inevitably reflected in a reorganization of hospital activities, including the diagnostic and therapeutic pathways for PC treatment. With the aim of giving an objective and real representation of the impact of Covid-19 on PC treatment, the investigator here propose a multicenter Italian observational study comparing a 6-month period before and during the Covid-19 pandemic. Only high-volume centers will be involved in the study. A comparison between the general, clinical, endoscopic and surgical outcomes will be performed by means of a global and month-by-month analysis between the two study periods.

Official Title
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Effects of Covid-19 Pandemic on Pancreatic Surgery in Italy. A Multicenter Observational Clinical Study

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Procedure: Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients with a diagnosis of pancreatic cancer referred to one of the centers involved in the study during the two study periods Exclusion Criteria: patients under the age of 18 inability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-COVID<br>All patients with pancreatic cancer diagnosis before COVID-19 pandemic | Procedure: Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer<br>* Comparison between the pre-COVID and COVID groups of general, clinical, endoscopic and surgical outcomes<br>|
| COVID<br>All patients with pancreatic cancer diagnosis during COVID-19 pandemic | Procedure: Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer<br>* Comparison between the pre-COVID and COVID groups of general, clinical, endoscopic and surgical outcomes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pancreatic cancer management during the COVID-19 pandemic |  | From admission to discharge/last outpatient visit, whichever comes first, assessed up to the 30th of June 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, Pancreatic surgery, COVID-19