Evaluation of Biomechanical Forced During the Practice of Endoscopic Retrograde Cholangiopancreatography
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CAPTIV system.
- Who it may be relevant to
- Registry conditions: ERCP, Biomechanic, Musculoskeletal Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
A number of best practice recommendations have been developed to improve practitioner comfort, similar to those recommended for digestive surgeons. It is recommended to use a height-adjustable examination table, position the screen at eye level, and use a chair during the procedure. The use of lead aprons is essential for certain endoscopic procedures (ERCP drainage of the bile ducts, prosthesis placement, etc.). Several retrospective studies in the surgical and radiological fields have shown an increased risk of MSDs among these populations. To distribute the weight of the apron, several shapes are available to limit stress. An apron weighs approximately 7 kg, due in particular to the amount of lead. The aim of this study is to evaluate the biomechanical forced experienced by the gastroenterologist during ERCP.
Interventions
- Device CAPTIV system
Each practitioner will perform 4 ERCP recorded using the CAPTIV system. In order to know the biomechanical constraints during standard endoscopic examination (upper endoscopy and colonoscopy), an upper endoscopy and a standard colonoscopy examination will also be filmed and monitored.
Primary outcome measures
- measurement of average muscle during ERCP [Time frame: 1 day]
- measurement of angular analysis during ERCP [Time frame: day 1]
Secondary outcome measures (1)
- level of stress during the practice of ERCP [Time frame: day 1]
Eligibility criteria
Inclusion criteria
- Adult subject (age ≥ 18 years)
- hepato-gastroenterologist
- Performing ERCP
- Person who has given consent for participation in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Centre Hospitalier Universitaire d'Amiens — Amiens
Identifiers
NCT: NCT07691580 · PI2026_843_0024