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CompletedNCT04385147Updated Jul 8, 2020

Advanced Endoscopy During COVID-19

An observational study in Cholangitis, Secondary Biliary, Cholangiocarcinoma and Obstructive Jaundice, sponsored by Al-Azhar University. Completed at 5 sites in 5 countries. Per ClinicalTrials.gov, last updated 2020-07-08.

Sponsored by Al-Azhar University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
670
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Inclusion criteria

  • Patients referred for ERCP or EUS during the study period

Exclusion criteria

Exclusion Criteria:

  • Patients refusing to participate in the study
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
670 participants (actual)
Patient registry
No

Groups and cohorts

  • ERCP

    Patients who will have endoscopic retrograde cholangiopancreatography

    Other: Endoscopic management according to standard of care

  • EUS

    Patients who will have endoscopic ultrasound

    Other: Endoscopic management according to standard of care

Interventions

  • OtherEndoscopic management according to standard of care

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

05

What researchers measure

Primary outcomes

  1. Age, gender, nationality

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

    Time frame: 3 months

  2. Indication for procedure, status of SARS-CoV-2 infection

    Investigators will report the baseline data clinical data (indication for procedure, status of SARS-CoV-2 infection) of all patients.

    Time frame: 3 months

  3. Complete blood count and liver functions tests

    Investigators will report the baseline laboratory data (complete blood count and liver functions tests) of all patients.

    Time frame: 3 months

  4. procedure related complications

    Investigators will report the procedure related complications.

    Time frame: 3 months

Secondary outcomes

  1. Effect of COVID-19 precautions on procedure time

    Investigators will report wether the precautions lead to increase timing of the procedure

    Time frame: 3 months

  2. Effect of COVID-19 precautions on staff number

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

    Time frame: 3 months

06

Study locations

5 sites
  • Kings County Hospital Center, Brooklyn, NY, USA
    Albertson, New York 11507, United States
  • Al-Azhar Univerisity
    Cairo, 11651, Egypt
  • University Medicine Greifswald
    Greifswald, D-17475, Germany
  • 2- Hospital Guillermo Kaelin De la Fuente - EsSalud
    Lima, Peru
  • Singapore General Hospital
    Singapore, 169856, Singapore
07

References and documents

Individual participant data

Plan to share: Undecided — Investigators may share data after first publication

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04385147
Lead sponsor
Al-Azhar University
Collaborators
Helwan University, National Liver Institute, Egypt
Responsible party
Mohamed Alboraie (Lecturer of medicine and gastroenterology, Al-Azhar University) — Principal investigator
First posted
May 12, 2020
Start date
May 18, 2020
Primary completion
Jul 1, 2020
Completion
Jul 5, 2020
Last update
Jul 8, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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