Advanced Endoscopy During COVID-19

July 7, 2020 updated by: Mohamed Alboraie, Al-Azhar University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

670

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11651
        • Al-Azhar Univerisity
  • Germany
      • Greifswald, Germany, D-17475
        • University Medicine Greifswald
  • Peru
      • Lima, Peru
        • 2- Hospital Guillermo Kaelin De la Fuente - EsSalud
  • Singapore
      • Singapore, Singapore, 169856
        • Singapore General Hospital
  • United States
    • New York
      • Albertson, New York, United States, 11507
        • Kings County Hospital Center, Brooklyn, NY, USA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients with digestive disorders referred for ERCP or EUS during the study period in the participating centers

Description

Inclusion Criteria:

  • Patients referred for ERCP or EUS during the study period

Exclusion Criteria:

  • Patients refusing to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ERCP
Patients who will have endoscopic retrograde cholangiopancreatography
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
EUS
Patients who will have endoscopic ultrasound
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age, gender, nationality
Time Frame: 3 months
Investigators will report the baseline demographic data (age, gender, nationality) of all patients.
3 months
Indication for procedure, status of SARS-CoV-2 infection
Time Frame: 3 months
Investigators will report the baseline data clinical data (indication for procedure, status of SARS-CoV-2 infection) of all patients.
3 months
Complete blood count and liver functions tests
Time Frame: 3 months
Investigators will report the baseline laboratory data (complete blood count and liver functions tests) of all patients.
3 months
procedure related complications
Time Frame: 3 months
Investigators will report the procedure related complications.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of COVID-19 precautions on procedure time
Time Frame: 3 months
Investigators will report wether the precautions lead to increase timing of the procedure
3 months
Effect of COVID-19 precautions on staff number
Time Frame: 3 months
Investigators will report wether the precautions affected staff number (increased or decreased)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Collaborators

Helwan University
National Liver Institute, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2020

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 5, 2020

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Global-Endo-COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Investigators may share data after first publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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