About this trial
Endoscopic Retrograde Cholangiopancreatography (ERCP) is a specialized procedure combining upper GI endoscopy and x-rays to treat hepatopancreaticobiliary diseases. Patient experiences after ERCP has been relatively understudied.
The goal of this prospective observational study is to understand how anxiety before ERCP affects patient experience and tolerance of the procedure.
This study includes adults (18 years and older) undergoing ERCP with conscious sedation at Kingston Health Sciences Centre. Researchers will measure pre-procedure anxiety and examine how it relates to patient comfort, cooperation during the procedure, and overall patient-reported experience.
The main questions are whether higher pre-procedure anxiety is associated with lower procedure tolerability and reduced cooperation during ERCP.
Participants will:
1. Complete a short anxiety questionnaire before the procedure 2. Undergo ERCP with standard sedation as planned by their care team 3. Complete a post-procedure questionnaire about comfort, pain, and other symptoms 4. Have procedure details and outcomes recorded from medical records
Endoscopists will also complete a short survey to state any concerns prior to procedure as well as evaluate patient's cooperation during the procedure.
Patient-reported experience will be compared with physician assessments of cooperation during the procedure.
Findings may help recognize patients at higher risk of distress during ERCP and guide strategies to improve comfort, sedation planning, and overall procedure quality to lead to the best outcomes.
Eligibility criteria
Qualifiers
Adults aged ≥18 years
Undergoing ERCP for any indication with conscious sedation
Able to provide informed consent
Disqualifiers
Age <18 years
Inability or refusal to provide informed consent
Cognitive impairment or language barriers precluding questionnaire completion
Emergent ERCP where pre-procedural questionnaire administration is not feasible
Trial design
Treatments tested in this trial
- Not applicable- observational study
Treatment groups
Locations
1Sponsors and collaborators
Mandip Rai
Lead sponsor
Queen's University
Sponsor institution
Queen's University
Collaborator