SmartGlass-Guided ERCP with Cannulation of Native Papilla 1.0

NCT06683716 | Not Yet Recruiting

• 1 other identifier: Helios SN GAS 2024-11-01
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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).

Conditions

Biliary Tract Diseases; Pancreatic Diseases

Keywords

Telemedicine; Training Technique; Cholangiopancreatography, Endoscopic Retrograde

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Adverse events during and after ERCP

  Time interval between insertion of the endoscope through the mouth up to 48 hours after ERCP

Study Arms (2)

Training in presence

ACTIVE COMPARATOR

The instructor teaches the trainee in physical presence during the ERCP

Other: Training in presence of the instructor

Telemedical training

EXPERIMENTAL

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

Other: Telemedically training by an instructor

Interventions

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.

Training in presence

Telemedically training by an instructor OTHER

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

Telemedical training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Helios Kliniken Schwerin: lead

Study Sites (1)

Helios Kliniken Schwerin

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

Related Publications (3)

• 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 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.

  PMID: 27299638 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.

  PMID: 36849287 BACKGROUND

MeSH Terms

Conditions

Biliary Tract Diseases; Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Daniel Schmitz, Dr.med.

  Helios Kliniken Schwerin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head physician of the Department of Gastroenterology

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

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 12, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Immediately after acceptance of the manuscript for publication
• Access Criteria: No limitation

Locations

DE (1)