SmartGlass-Guided ERCP with Cannulation of Native Papilla 1.0 (EmeRald)

Helios Kliniken Schwerin

Status: Not yet enrolling

Conditions: Pancreatic Diseases; Biliary Tract Diseases

Treatments: Other: Training in presence of the instructor; Other: Telemedically training by an instructor

Study type: Interventional

Funder types: Other

Identifiers

NCT06683716

Helios SN GAS 2024-11-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Training in presence

Active Comparator group

Description:

The instructor teaches the trainee in physical presence during the ERCP

Treatment:

Other: Training in presence of the instructor

Telemedical training

Experimental group

Description:

The instructor teaches the trainee telemedically by using smartglasses during the ERCP

Treatment:

Other: Telemedically training by an instructor