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

NCT07699731 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-07-13

No results posted yet for this study

Summary

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.

Conditions

  • Anxiety
  • Biliary and Pancreatic Diseases
  • ERCP

Interventions

OTHER

Not applicable- observational study

Not applicable - observational study

Sponsors & Collaborators

  • Queen's University

    collaborator OTHER

  • Mandip Rai

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-08-01
Completion
2027-10-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07699731 on ClinicalTrials.gov