Covid-19 Pandemic and Pancreatic Surgery in Italy

Completed

• Conditions: Pancreatic Cancer
• Interventions: Procedure: Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer

• Registration Number: NCT04380766
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-08
• Status Verified: 2020-07
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 730

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID	Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer	All patients with pancreatic cancer diagnosis during COVID-19 pandemic
Pre-COVID	Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer	All patients with pancreatic cancer diagnosis before COVID-19 pandemic

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma; 🇮🇹 Roma, Lazio, Italy