SmartGlass-Guided ERCP with Cannulation of Native Papilla 1.0

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-02

Study Completion Date

2026-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Biliary Tract Diseases Pancreatic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomised non-inferiority trial comparing two training conditions in gastrointestinal endoscopy (ERCP)

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Training in presence

The instructor teaches the trainee in physical presence during the ERCP

Group Type ACTIVE_COMPARATOR

Training in presence of the instructor

Intervention Type OTHER

The instructor gives the trainee instructions for the examination while he/she is present in the examination room.

Telemedical training

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

Group Type EXPERIMENTAL

Telemedically training by an instructor

Intervention Type OTHER

The trainer gives instructions to the trainee through a telemedical connection to the examiner using SmartGlasses

Interventions

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Training in presence of the instructor

The instructor gives the trainee instructions for the examination while he/she is present in the examination room.

Intervention Type OTHER

Telemedically training by an instructor

The trainer gives instructions to the trainee through a telemedical connection to the examiner using SmartGlasses

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No