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Completed

NCT Number: NCT04385147

Advanced Endoscopy During COVID-19

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

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Key information

Conditions

Cholangitis, Secondary Biliary Adenocarcinoma Bile Duct Diseases Biliary Tract Diseases COVID-19 Carcinoma Cholangiocarcinoma Cholangitis Cholestasis Cholestasis, Intrahepatic Coronaviridae Infections Coronavirus Infections Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fibrosis Hyperbilirubinemia Infections Jaundice Jaundice, Obstructive Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Lung Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nidovirales Infections Obstructive Jaundice Pancreas Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Signs and Symptoms Skin Manifestations Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Al-Azhar Univerisity, Cairo, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients referred for ERCP or EUS during the study period

Exclusion criteria

  • Patients refusing to participate in the study

Treatment and study plan

Endoscopic management according to standard of care

Other

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

Primary outcomes

  1. Age, gender, nationality

    Time frame: 3 months

    Investigators will report the baseline demographic data (age, gender, nationality) of all patients.

  2. 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. 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.

  4. procedure related complications

    Time frame: 3 months

    Investigators will report the procedure related complications.

Secondary outcomes

  1. 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

  2. Effect of COVID-19 precautions on staff number

    Time frame: 3 months

    Investigators will report wether the precautions affected staff number (increased or decreased)

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Collaborators

  • Helwan University
  • National Liver Institute, Egypt

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 12, 2020
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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