Evaluation of Biomechanical Forced During the Practice of Endoscopic Retrograde Cholangiopancreatography

NCT07691580 | Recruiting

• 1 other identifier: PI2026_843_0024
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ERCP; Musculoskeletal Disorders; Biomechanic

Keywords

musculoskeletal disorders; ERCP; biomechanic; physiology

Outcome Measures

Primary Outcomes (2)

• measurement of average muscle during ERCP

  measurement of average muscle during ERCP

  1 day

• measurement of angular analysis during ERCP

  day 1

Secondary Outcomes (1)

• level of stress during the practice of ERCP

  day 1

Study Arms (1)

CAPTIV system

EXPERIMENTAL

• 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.

Device: CAPTIV system

Interventions

CAPTIV system DEVICE

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.

CAPTIV system

Eligibility Criteria

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

You may qualify if:

• Adult subject (age ≥ 18 years)
• hepato-gastroenterologist
• Performing ERCP
• Person who has given consent for participation in the study

Sponsors & Collaborators

• Central Hospital, Nancy, France: collaborator
• University Hospital, Caen: collaborator
• Centre Hospitalier Universitaire, Amiens: lead
• Clinique de l'Europe, Amiens: collaborator
• Hôpital Privé Saint-Claude, Saint Quentin: collaborator

Study Sites (1)

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, 80000, France

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Central Study Contacts

Clara YZET, DR

CONTACT

33+3 22 08 88 50; yzet.clara@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)