An interventional study of Training in presence of the instructor and Telemedically training by an instructor in Biliary Tract Diseases and Pancreatic Diseases, sponsored by Helios Kliniken Schwerin. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Helios Kliniken Schwerin · Not applicable, Interventional, and Other
The aim of this prospective randomized study is to evaluate whether telemedical assistance via SmartGlasses is equivalent to physical presence in teaching Endoscopic Retrograde Cholangiopancreaticography (ERCP) in terms of examination success and safety. Endoscopic papilla cannulation is a key skill for successful ERCP and therefore a measurable primary endpoint of the study. This can be measured as the time (in seconds/minutes) between stable visualization of the papilla and successful endoscopic cannulation of the target structure (bile duct or pancreatic duct).
In sparsely populated regions of a country and where there is a lack of experienced specialists, it may not always be possible to have an experienced ERCP examiner present during an examination. Therefore, telemedical examination assistance via a connection to data glasses worn by the examiner is a possible option to replace the physical presence of an instructor or experienced ERCP examiner.
The aim of this prospective randomized study is to evaluate whether telemedical assistance via smart glasses is equivalent to physical presence in terms of examination success and safety. Endoscopic papilla cannulation is a key skill for successful ERCP and therefore a measurable primary endpoint of the study. This can be measured as the time (in seconds/minutes) between stable visualization of the papilla and successful endoscopic cannulation of the target structure (bile duct or pancreatic duct).
In addition to other efficacy endpoints, adverse events, which are expected to be rare, will be documented at 48-hour intervals and calculated as a rate. Telemedical 'live' support of an ERCP via data glasses has not yet been demonstrated or tested in a trial. To ensure the safety of the examination under these circumstances, the training examiner is present in the neighbouring room and can physically assist or take over the examination at any time if necessary.
59 studies on the registry are indexed under Biliary Tract Diseases; 12 are open to participants now.
This study's planned enrollment of 170 is above the median of 84 across 37 interventional studies indexed under Biliary Tract Diseases.
Browse Biliary Tract Diseases studies →Helios Kliniken Schwerin is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The instructor teaches the trainee in physical presence during the ERCP
Other: Training in presence of the instructor
The instructor teaches the trainee telemedically by using smartglasses during the ERCP
Other: Telemedically training by an instructor
The instructor gives the trainee instructions for the examination while he/she is present in the examination room.
The trainer gives instructions to the trainee through a telemedical connection to the examiner using SmartGlasses
Papilla cannulation time
Time to cannulate the native papilla during ERCP
Time frame: During the intervention: from the stable visualisation of the papilla until the successful cannulation of the papilla, assessed up to 60 minutes
Adverse events during and after ERCP
All adverse events that occur during ERCP and after ERCP: number (n)
Time frame: Time interval between insertion of the endoscope through the mouth up to 48 hours after ERCP
Plan to share: Yes — It is planned to share the IPD in a public repository such as re3data.org
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: Immediately after acceptance of the manuscript for publication
Access criteria: No limitation
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Helios Kliniken Schwerin