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NCT04385147 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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