Advanced Endoscopy During COVID-19
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ClinicalTrials.gov Identifier: NCT04385147 |
Recruitment Status :
Completed
First Posted : May 12, 2020
Last Update Posted : July 8, 2020
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Condition or disease | Intervention/treatment |
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Cholangitis, Secondary Biliary Cholangiocarcinoma Obstructive Jaundice Pancreas Cancer COVID-19 SARS-CoV-2 | Other: Endoscopic management according to standard of care |
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:
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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.
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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.
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 |

Group/Cohort | Intervention/treatment |
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ERCP
Patients who will have endoscopic retrograde cholangiopancreatography
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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
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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 |
- Age, gender, nationality [ Time Frame: 3 months ]Investigators will report the baseline demographic data (age, gender, nationality) of all patients.
- 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.
- 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.
- procedure related complications [ Time Frame: 3 months ]Investigators will report the procedure related complications.
- 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
- Effect of COVID-19 precautions on staff number [ Time Frame: 3 months ]Investigators will report wether the precautions affected staff number (increased or decreased)

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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 |
Inclusion Criteria:
- Patients referred for ERCP or EUS during the study period
Exclusion Criteria:
- Patients refusing to participate in the study

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
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Obstructive Jaundice Cholangitis Pancreas Cancer COVID-19 SARS-CoV-2 |
esophagogastroduodenoscopy Endoscopy Endoscopic retrograde cholangiopancreatography Endoscopic ultrasound |
COVID-19 Cholangiocarcinoma Pancreatic Neoplasms Cholangitis Liver Cirrhosis, Biliary Jaundice Jaundice, Obstructive Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases 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 |