Effect of Patient Anxiety Level Prior to Undergoing ERCP and Procedure Tolerability and Outcomes.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMandip Rai

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

200 Participants
are divided into 1 treatment group

Locations

1
Kingston Health Sciences Centre KingstonOntario, Canada

Sponsors and collaborators

Mandip Rai

Lead sponsor

Queen's University

Sponsor institution

Queen's University

Collaborator