NCT04385147

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
670

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

May 18, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2020

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

May 11, 2020

Last Update Submit

July 7, 2020

Conditions

Cholangitis, Secondary BiliaryCholangiocarcinomaObstructive JaundicePancreas CancerCOVID-19SARS-CoV-2

Keywords

Obstructive JaundiceCholangitisPancreas CancerCOVID-19SARS-CoV-2esophagogastroduodenoscopyEndoscopyEndoscopic retrograde cholangiopancreatographyEndoscopic ultrasound

Outcome Measures

Primary Outcomes (4)

  • Age, gender, nationality

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

    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.

    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.

    3 months

  • procedure related complications

    Investigators will report the procedure related complications.

    3 months

Secondary Outcomes (2)

  • Effect of COVID-19 precautions on procedure time

    3 months

  • Effect of COVID-19 precautions on staff number

    3 months

Study Arms (2)

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

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

ERCPEUS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with digestive disorders referred for ERCP or EUS during the study period in the participating centers

You may qualify if:

  • Patients referred for ERCP or EUS during the study period

You may not qualify if:

  • Patients refusing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Kings County Hospital Center, Brooklyn, NY, USA

Albertson, New York, 11507, United States

Location

Al-Azhar Univerisity

Cairo, 11651, Egypt

Location

University Medicine Greifswald

Greifswald, D-17475, Germany

Location

2- Hospital Guillermo Kaelin De la Fuente - EsSalud

Lima, Peru

Location

Singapore General Hospital

Singapore, 169856, Singapore

Location

MeSH Terms

Conditions

Liver Cirrhosis, BiliaryCholangiocarcinomaJaundice, ObstructivePancreatic NeoplasmsCOVID-19Cholangitis

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsJaundiceHyperbilirubinemiaSkin ManifestationsSigns and SymptomsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of medicine and gastroenterology

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 12, 2020

Study Start

May 18, 2020

Primary Completion

July 1, 2020

Study Completion

July 5, 2020

Last Updated

July 8, 2020

Record last verified: 2020-07

Locations

PE(1)US(1)SG(1)EG(1)DE(1)