Advanced Endoscopy During COVID-19

Completed

• Conditions: Cholangiocarcinoma; Obstructive Jaundice; Pancreas Cancer; SARS-CoV-2; Cholangitis, Secondary Biliary; COVID-19
• Interventions: Other: Endoscopic management according to standard of care

• Registration Number: NCT04385147
• Lead Sponsor: Al-Azhar University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Study Start: 2020-05-18
• Status Verified: 2020-07
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-05
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 670

Inclusion Criteria

• Patients referred for ERCP or EUS during the study period

Exclusion Criteria

• Patients refusing to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ERCP	Endoscopic management according to standard of care	Patients who will have endoscopic retrograde cholangiopancreatography
EUS	Endoscopic management according to standard of care	Patients who will have endoscopic ultrasound

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Kings County Hospital Center, Brooklyn, NY, USA; 🇺🇸 Albertson, New York, United States

Al-Azhar Univerisity; 🇪🇬 Cairo, Egypt

Singapore General Hospital; 🇸🇬 Singapore, Singapore

University Medicine Greifswald; 🇩🇪 Greifswald, Germany

2- Hospital Guillermo Kaelin De la Fuente - EsSalud; 🇵🇪 Lima, Peru