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Advanced Endoscopy During COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04385147
Recruitment Status : Completed
First Posted : May 12, 2020
Last Update Posted : July 8, 2020
Sponsor:
Collaborators:
Helwan University
National Liver Institute, Egypt
Information provided by (Responsible Party):
Mohamed Alboraie, Al-Azhar University

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

Condition or disease Intervention/treatment
Cholangitis, Secondary Biliary Cholangiocarcinoma Obstructive Jaundice Pancreas Cancer COVID-19 SARS-CoV-2 Other: Endoscopic management according to standard of care

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 Design
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Study Type : Observational
Actual Enrollment : 670 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Status of Advanced Endoscopy in the Era of COVID-19: a Multicenter Study
Actual Study Start Date : May 18, 2020
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with digestive disorders referred for ERCP or EUS during the study period in the participating centers
Criteria

Inclusion Criteria:

  • Patients referred for ERCP or EUS during the study period

Exclusion Criteria:

  • Patients refusing to participate in the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385147


Locations
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United States, New York
Kings County Hospital Center, Brooklyn, NY, USA
Albertson, New York, United States, 11507
Egypt
Al-Azhar Univerisity
Cairo, Egypt, 11651
Germany
University Medicine Greifswald
Greifswald, Germany, D-17475
Peru
2- Hospital Guillermo Kaelin De la Fuente - EsSalud
Lima, Peru
Singapore
Singapore General Hospital
Singapore, Singapore, 169856
Sponsors and Collaborators
Al-Azhar University
Helwan University
National Liver Institute, Egypt
More Information
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Responsible Party: Mohamed Alboraie, Lecturer of medicine and gastroenterology, Al-Azhar University
ClinicalTrials.gov Identifier: NCT04385147    
Other Study ID Numbers: Global-Endo-COVID
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Investigators may share data after first publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Alboraie, Al-Azhar University:
Obstructive Jaundice
Cholangitis
Pancreas Cancer
COVID-19
SARS-CoV-2
 esophagogastroduodenoscopy
Endoscopy
Endoscopic retrograde cholangiopancreatography
Endoscopic ultrasound
Additional relevant MeSH terms:
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Cholangiocarcinoma
Pancreatic Neoplasms
Cholangitis
Liver Cirrhosis, Biliary
Jaundice
Jaundice, Obstructive
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
 Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
Liver Cirrhosis