Effect of Patient Anxiety Level Prior to Undergoing ERCP and Procedure Tolerability and Outcomes.
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Conditions studied: Anxiety, Biliary and Pancreatic Diseases, ERCP
In brief
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.
Key facts
- Study ID
- NCT07699731
- Run by
- Mandip Rai
- People needed
- 200
- Starts
- 2026-08-01
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults aged ≥18 years
- Undergoing ERCP for any indication with conscious sedation
- Able to provide informed consent
You may not qualify if…
- 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
Where it is running
- Kingston Health Sciences Centre — Kingston, Ontario, Canada
Full record on ClinicalTrials.gov
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