SmartGlass-Guided ERCP with Cannulation of Native Papilla 1.0
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelios Kliniken Schwerin
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged ≥ 18 years without previous papillotomy
Disqualifiers
Cannulation of the minor papilla necessary
Significant comorbidity
Haemodynamic instability
Pregnant women
Trial design
Design model
Parallel
Treatments tested in this trial
Training in presence of the instructor
Other interventionThe instructor gives the trainee instructions for the examination while he/she is present in the examination room.
Telemedically training by an instructor
Other interventionThe trainer gives instructions to the trainee through a telemedical connection to the examiner using SmartGlasses
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Training in presenceActive comparator 1 intervention
Group B: Telemedical trainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 minutesSecondary outcomes
1
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 ERCPSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: