Clinical trial NCT06683716: SmartGlass-Guided ERCP with Cannulation of Native Papilla 1.0
Official title: Remote Assistance Via Smart Glasses Compared to In-person Assistance for Cannulation of the Native Papilla During Endoscopic Retrograde Cholangiopancreatography
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Biliary Tract Diseases
Pancreatic Diseases
Keywords: Telemedicine
Training Technique
Cholangiopancreatography, Endoscopic Retrograde
Lead sponsor: Helios Kliniken Schwerin
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomised non-inferiority trial comparing two training conditions in gastrointestinal endoscopy (ERCP)
Primary purpose: OTHER

Brief summary: 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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Papilla cannulation time
timeFrame: During the intervention: from the stable visualisation of the papilla until the successful cannulation of the papilla, assessed up to 60 minutes
Secondary outcomes:
measure: Adverse events during and after ERCP
timeFrame: Time interval between insertion of the endoscope through the mouth up to 48 hours after ERCP
Other outcomes:
Locations:
city: Schwerin
country: Germany
facility: Helios Kliniken Schwerin
state: Mecklenburg-Vorpommern
Study officials:
affiliation: Helios Kliniken Schwerin
name: Daniel Schmitz, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.