Advanced Endoscopy During COVID-19

• Sponsor: Al-Azhar University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04385147
• Collaborator: Helwan University (Other), National Liver Institute, Egypt (Other)
• Enrollment: 670
• Locations: 5
• Actual Duration (Months): 1.6
• Patients Per Site: 134
• Patients Per Site Per Month: 85

Study Details

Study Description

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	Phase
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

• 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: Jul 1, 2020
• Actual Study Completion Date: Jul 5, 2020

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Age, gender, nationality [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 [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 [3 months]

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

4. procedure related complications [3 months]

   Investigators will report the procedure related complications.

Secondary Outcome Measures

1. Effect of COVID-19 precautions on procedure time [3 months]

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

2. Effect of COVID-19 precautions on staff number [3 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients referred for ERCP or EUS during the study period

Exclusion Criteria:

• Patients refusing to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kings County Hospital Center, Brooklyn, NY, USA	Albertson	New York	United States	11507
2	Al-Azhar Univerisity	Cairo		Egypt	11651
3	University Medicine Greifswald	Greifswald		Germany	D-17475
4	2- Hospital Guillermo Kaelin De la Fuente - EsSalud	Lima		Peru
5	Singapore General Hospital	Singapore		Singapore	169856

Sponsors and Collaborators

• Al-Azhar University
• Helwan University
• National Liver Institute, Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Last Update Posted: Jul 8, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohamed Alboraie, Lecturer of medicine and gastroenterology, Al-Azhar University: Obstructive Jaundice; Cholangitis; Pancreas Cancer; COVID-19; SARS-CoV-2; esophagogastroduodenoscopy; Endoscopy; Endoscopic retrograde cholangiopancreatography; Endoscopic ultrasound
• Additional relevant MeSH terms: COVID-19; Cholangiocarcinoma; Pancreatic Neoplasms; Cholangitis; Liver Cirrhosis, Biliary; Jaundice; Jaundice, Obstructive

Study Results

No Results Posted as of Jul 8, 2020