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

Qualifiers

Adult patients aged ≥ 18 years without previous papillotomy

Disqualifiers

Cannulation of the minor papilla necessary

Significant comorbidity

Haemodynamic instability

Pregnant women

Trial design

Treatments tested in this trial

  • Training in presence of the instructor
  • Telemedically training by an instructor

Treatment groups

170 Participants
are divided into 2 treatment groups

Sponsors and collaborators