Advanced Endoscopy During COVID-19

COVID-19 Clinical Trial

Official title:

The Status of Advanced Endoscopy in the Era of COVID-19: a Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385147
• Other study ID #: Global-Endo-COVID
• Status: Completed
• Start date: May 18, 2020
• Est. completion date: July 5, 2020

Study information

• Verified date: July 2020
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, investigators aim to explore the status of advanced endoscopy in different endoscopy units all over the world.

Description:

In this study, investigators aim to explore the status of advanced endoscopy (endoscopic retrograde cholangiopancreatography and endoscopic ultrasound on a global level) in different endoscopy units all over the world, to report the characteristics of patients presented to these units and their procedure details.

evaluate the validity of different GI societies recommendations applied in different GI endoscopy units on the prevention of SARS-CoV-2 nosocomial transmission and the overall impact of this recommendations on the service provided by each GI unit.

Target audience:

• Physicians performing advanced gastrointestinal endoscopies in different countries.

Objectives:

• Primary objective:

1- To explore the status of advanced endoscopy (endoscopic retrograde cholangiopancreatography and endoscopic ultrasound on a global level) in different endoscopy units all over the world, to report the characteristics of patients presented to these units and their procedure details.

• Secondary objectives:

1. Effect of COVID-19 precautions on procedure time, procedure success, complications and patient outcomes

2. Effect of COVID-19 on working time and staff number

Process:

A questionnaire containing advanced endoscopy procedure details in different countries will be distributed via emails. Responses will be collected in an online platform and data will be analyzed to reveal the effect of SARS-CoV-2 pandemic on different aspects of advanced endoscopy practice in the studied countries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 670
• Est. completion date: July 5, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients referred for ERCP or EUS during the study period

Exclusion Criteria:

• Patients refusing to participate in the study

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Cholangitis
• Cholangitis, Secondary Biliary
• COVID-19
• Jaundice
• Jaundice, Obstructive
• Liver Cirrhosis, Biliary
• Obstructive Jaundice
• Pancreas Cancer
• Pancreatic Neoplasms
• SARS-CoV-2

Intervention

Other:
• Endoscopic management according to standard of care
Endoscopic management according to standard of care by ERCP or EUS according to the indication in each case

Locations

Country	Name	City	State
Egypt	Al-Azhar Univerisity	Cairo
Germany	University Medicine Greifswald	Greifswald
Peru	2- Hospital Guillermo Kaelin De la Fuente - EsSalud	Lima
Singapore	Singapore General Hospital	Singapore
United States	Kings County Hospital Center, Brooklyn, NY, USA	Albertson	New York

Sponsors (3)

Lead Sponsor	Collaborator
Al-Azhar University	Helwan University, National Liver Institute, Egypt

Countries where clinical trial is conducted

United States,  Egypt,  Germany,  Peru,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age, gender, nationality	Investigators will report the baseline demographic data (age, gender, nationality) of all patients.	3 months
Primary	Indication for procedure, status of SARS-CoV-2 infection	Investigators will report the baseline data clinical data (indication for procedure, status of SARS-CoV-2 infection) of all patients.	3 months
Primary	Complete blood count and liver functions tests	Investigators will report the baseline laboratory data (complete blood count and liver functions tests) of all patients.	3 months
Primary	procedure related complications	Investigators will report the procedure related complications.	3 months
Secondary	Effect of COVID-19 precautions on procedure time	Investigators will report wether the precautions lead to increase timing of the procedure	3 months
Secondary	Effect of COVID-19 precautions on staff number	Investigators will report wether the precautions affected staff number (increased or decreased)	3 months