SmartGlass-Guided ERCP with Cannulation of Native Papilla 1.0

Официальное название

Remote Assistance Via Smart Glasses Compared to In-person Assistance for Cannulation of the Native Papilla During Endoscopic Retrograde Cholangiopancreatography

Обзор

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).

Подробное описание

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.

Вмешательства

• Другое Training in presence of the instructor
  The instructor gives the trainee instructions for the examination while he/she is present in the examination room.
• Другое Telemedically training by an instructor
  The trainer gives instructions to the trainee through a telemedical connection to the examiner using SmartGlasses

Первичные конечные точки

• Papilla cannulation time [Срок оценки: During the intervention: from the stable visualisation of the papilla until the successful cannulation of the papilla, assessed up to 60 minutes]

Вторичные конечные точки (1)

• Adverse events during and after ERCP [Срок оценки: Time interval between insertion of the endoscope through the mouth up to 48 hours after ERCP]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Германия · 1 центр

• Helios Kliniken Schwerin — Schwerin

Публикации

• Pan Y, Zhao L, Leung J, Zhang R, Luo H, Wang X, Liu Z, Wan B, Tao Q, Yao S, Hui N, Fan D, Wu K, Guo X. Appropriate time for selective biliary cannulation by trainees during ERCP--a randomized trial. Endoscopy. 2015 Aug;47(8):688-95. doi: 10.1055/s-0034-1391564. Epub 2015 Mar 6. PMID 25750038
• Testoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 J PMID 27299638
• Biancheri P, Soriani P, Gabbani T, Bonura GF, Manno M. Smart glasses: Taking GI endoscopy to the metaverse era. Dig Liver Dis. 2023 May;55(5):692-693. doi: 10.1016/j.dld.2023.02.001. Epub 2023 Feb 26. No abstract available. PMID 36849287

Идентификаторы

NCT: NCT06683716 · Helios SN GAS 2024-11-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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