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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training in presence | Active Comparator | The instructor teaches the trainee in physical presence during the ERCP |
|
| Telemedical training | Experimental | The instructor teaches the trainee telemedically by using smartglasses during the ERCP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training in presence of the instructor | Other | The instructor gives the trainee instructions for the examination while he/she is present in the examination room. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Papilla cannulation time | Time to cannulate the native papilla during ERCP | During the intervention: from the stable visualisation of the papilla until the successful cannulation of the papilla, assessed up to 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events during and after ERCP | All adverse events that occur during ERCP and after ERCP: number (n) | Time interval between insertion of the endoscope through the mouth up to 48 hours after ERCP |
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Inclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Schmitz, Dr. med. | Contact | +49-385-520-2601 | daniel.schmitz@helios-gesundheit.de | |
| Martin Kliment, Dr.med. | Contact | +49-385-520-2601 | Martin.Kliment@helios-gesundheit.de |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Schmitz, Dr.med. | Helios Kliniken Schwerin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helios Kliniken Schwerin | Schwerin | Mecklenburg-Vorpommern | 19055 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25750038 | Background | 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. | |
| 27299638 | Background | 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 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14. |
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It is planned to share the IPD in a public repository such as re3data.org
Immediately after acceptance of the manuscript for publication
No limitation
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| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D010182 | Pancreatic Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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Prospective randomised non-inferiority trial comparing two training conditions in gastrointestinal endoscopy (ERCP)
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| Telemedically training by an instructor | Other | The trainer gives instructions to the trainee through a telemedical connection to the examiner using SmartGlasses |
|
| 36849287 | Background | 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. |