Biliary Tract Diseases, Pancreatic Diseases
Conditions
Keywords
Telemedicine, Training Technique, Cholangiopancreatography, Endoscopic Retrograde
Brief summary
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).
Detailed description
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.
Interventions
OTHERTraining in presence of the instructor
The instructor gives the trainee instructions for the examination while he/she is present in the examination room.
OTHERTelemedically training by an instructor
The trainer gives instructions to the trainee through a telemedical connection to the examiner using SmartGlasses
Sponsors
Helios Kliniken Schwerin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective randomised non-inferiority trial comparing two training conditions in gastrointestinal endoscopy (ERCP)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients aged ≥ 18 years without previous papillotomy
Exclusion criteria
* Cannulation of the minor papilla necessary * Significant comorbidity * Haemodynamic instability * Pregnant women * Refusal or inability to give written informed consent for the study * Instructor had to perform the examination himself/herself
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Papilla cannulation time | During the intervention: from the stable visualisation of the papilla until the successful cannulation of the papilla, assessed up to 60 minutes | Time to cannulate the native papilla during ERCP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events during and after ERCP | Time interval between insertion of the endoscope through the mouth up to 48 hours after ERCP | All adverse events that occur during ERCP and after ERCP: number (n) |
Countries
Germany
Contacts
Primary ContactDaniel Schmitz, Dr. med.
Backup ContactMartin Kliment, Dr.med.
Outcome results
None listed