Covid-19 Pandemic and Pancreatic Surgery in Italy

Pancreatic Cancer Clinical Trial

— PanCOVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04380766
• Other study ID #: FPGemelliIRCCS
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: July 2020
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 730
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer
Comparison between the pre-COVID and COVID groups of general, clinical, endoscopic and surgical outcomes

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma	Roma	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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