Clinical trial NCT04385147: Advanced Endoscopy During COVID-19
Official title: The Status of Advanced Endoscopy in the Era of COVID-19: a Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholangitis, Secondary Biliary
Cholangiocarcinoma
Obstructive Jaundice
Pancreas Cancer
COVID-19
SARS-CoV-2
Keywords: Obstructive Jaundice
Cholangitis
Pancreas Cancer
COVID-19
SARS-CoV-2
esophagogastroduodenoscopy
Endoscopy
Endoscopic retrograde cholangiopancreatography
Endoscopic ultrasound
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Helwan University
name: National Liver Institute, Egypt
First posted: 2020-05-12
Enrollment: 670
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with digestive disorders referred for ERCP or EUS during the study period in the participating centers

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.

Eligibility criteria: Inclusion Criteria:

* Patients referred for ERCP or EUS during the study period

Exclusion Criteria:

* Patients refusing to participate in the study

Primary outcomes:
measure: Age, gender, nationality
timeFrame: 3 months
measure: Indication for procedure, status of SARS-CoV-2 infection
timeFrame: 3 months
measure: Complete blood count and liver functions tests
timeFrame: 3 months
measure: procedure related complications
timeFrame: 3 months
Secondary outcomes:
measure: Effect of COVID-19 precautions on procedure time
timeFrame: 3 months
measure: Effect of COVID-19 precautions on staff number
timeFrame: 3 months
Other outcomes:
Locations:
city: Albertson
country: United States
facility: Kings County Hospital Center, Brooklyn, NY, USA
state: New York
city: Cairo
country: Egypt
facility: Al-Azhar Univerisity
city: Greifswald
country: Germany
facility: University Medicine Greifswald
city: Lima
country: Peru
facility: 2- Hospital Guillermo Kaelin De la Fuente - EsSalud
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References: