Cholangitis, Secondary BiliaryNCT04385147
Advanced Endoscopy During COVID-19
An observational study of Cholangitis, Secondary Biliary and Cholangiocarcinoma, run by Al-Azhar University at 5 sites in 5 countries.
Trial summary
In this study, investigators aim to explore the status of advanced endoscopy in different endoscopy units all over the world. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholangitis, Secondary Biliary, Cholangiocarcinoma, Obstructive Jaundice
- How many people
- 670 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 18 May 2020to 5 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with digestive disorders referred for ERCP or EUS during the study period in the participating centers
Who may be able to join
- Patients referred for ERCP or EUS during the study period
Who cannot join
- Patients refusing to participate in the study
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
Kings County Hospital Center, Brooklyn, NY, USA
Albertson, New York, 11507
About this study
Official title: The Status of Advanced Endoscopy in the Era of COVID-19: a Multicenter Study
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:
- 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.
- Conditions
- Cholangitis, Secondary Biliary, Cholangiocarcinoma, Obstructive Jaundice, Pancreas Cancer, COVID-19, SARS-CoV-2
- Being tested
- Endoscopic management according to standard of care
- Keywords
- Obstructive Jaundice, Cholangitis, Pancreas Cancer, COVID-19, SARS-CoV-2, esophagogastroduodenoscopy, Endoscopy, Endoscopic retrograde cholangiopancreatography, Endoscopic ultrasound
- Medical subject headings
- Liver Cirrhosis, Biliary, Cholangiocarcinoma, Jaundice, Obstructive, Pancreatic Neoplasms, COVID-19, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic management according to standard of careOther
Endoscopic management according to standard of care by ERCP or EUS according to the indication in each case
| Study group | Role | What they receive |
|---|---|---|
| ERCP | Patients who will have endoscopic retrograde cholangiopancreatography Receives: Other: Endoscopic management according to standard of care | |
| EUS | Patients who will have endoscopic ultrasound Receives: Other: Endoscopic management according to standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age, gender, nationality
Investigators will report the baseline demographic data (age, gender, nationality) of all patients.
Measured: 3 months
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.
Measured: 3 months
Complete blood count and liver functions tests
Investigators will report the baseline laboratory data (complete blood count and liver functions tests) of all patients.
Measured: 3 months
procedure related complications
Investigators will report the procedure related complications.
Measured: 3 months
Secondary outcomes (2)
Effect of COVID-19 precautions on procedure time
Investigators will report wether the precautions lead to increase timing of the procedure
Measured: 3 months
Effect of COVID-19 precautions on staff number
Investigators will report wether the precautions affected staff number (increased or decreased)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start18 May 2020
- Primary completion1 Jul 2020
- Study completion5 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangitis, Secondary BiliaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Helwan University, National Liver Institute, Egypt
- Responsible party
- Principal investigator, Mohamed Alboraie, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385147
- Sponsor's protocol ID
- Global-Endo-COVID
- Status last verified
- Jul 2020
- First submitted
- 11 May 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Investigators may share data after first publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Status of Advanced Endoscopy in the Era of COVID-19: a Multicenter Study
- ClinicalTrials.gov ID
- NCT04385147
- Acronym / sponsor ID
- Global-Endo-COVID
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Helwan University, National Liver Institute, Egypt
- Study start
- 18 May 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 5 Jul 2020 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP | – | Other: Endoscopic management according to standard of carePatients who will have endoscopic retrograde cholangiopancreatography |
| EUS | – | Other: Endoscopic management according to standard of carePatients who will have endoscopic ultrasound |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with digestive disorders referred for ERCP or EUS during the study period in the participating centers
Key inclusion criteria (1 listed)
- Patients referred for ERCP or EUS during the study period
Key exclusion criteria (1 listed)
- Patients refusing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic management according to standard of careEndoscopic management according to standard of care by ERCP or EUS according to the indication in each case | Other | ERCP, EUS |
Primary outcome
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.
2 secondary outcomes
Effect of COVID-19 precautions on procedure time
Time frame: 3 months
Effect of COVID-19 precautions on staff number
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: Undecided. Investigators may share data after first publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangitis, Secondary Biliary and Cholangiocarcinoma, run by Al-Azhar University at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Egypt, Germany, Peru, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age, gender, nationality (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.