PanCOVID: Covid-19 Pandemic and Pancreatic Surgery in Italy

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Completed

CT.gov ID

NCT04380766

Collaborator

(none)

730

Enrollment

Location

Actual Duration (Months)

38.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Procedure: Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

730 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Jul 31, 2020

Actual Study Completion Date :

Jul 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Pre-COVID 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 Comparison between the pre-COVID and COVID groups of general, clinical, endoscopic and surgical outcomes
COVID 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 Comparison between the pre-COVID and COVID groups of general, clinical, endoscopic and surgical outcomes

Arm

Intervention/Treatment

Pre-COVID

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

Comparison between the pre-COVID and COVID groups of general, clinical, endoscopic and surgical outcomes

COVID

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

Comparison between the pre-COVID and COVID groups of general, clinical, endoscopic and surgical outcomes

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma	Roma	Lazio	Italy	00168

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sergio Alfieri, Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT04380766

Other Study ID Numbers:

FPGemelliIRCCS

First Posted:

May 8, 2020

Last Update Posted:

Aug 3, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sergio Alfieri, Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Pancreatic cancer

Pancreatic surgery

COVID-19

Additional relevant MeSH terms:

COVID-19

Pancreatic Neoplasms

Study Results

No Results Posted as of Aug 3, 2020