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

Sponsor
Mandip Rai
Study ID
NCT07699731
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Biliary and Pancreatic Diseases
  • ERCP

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Not applicable- observational study — OTHER
    Not applicable - observational study

Study Details

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 Dates

First listed
Jul 13, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Aug 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Patients undergoing ERCP
    Adult (\>18 years old) patients undergoing ERCP will be enrolled prospectively. All procedures will be performed according to standard clinical practice (No study intervention). Clinical, procedural, and patient-reported outcome data will be collected for analysis.

Primary Outcome Measure

Impact of pre-procedural anxiety on patient experience of ERCP [ Time Frame: STAY-Y measured perioperatively/periprocedurally. PROSTEP measured immediately after the procedure once the patient is awake and ready for DC. PROSAS measured immediately post procedure. ]

Central Contacts

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