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

NCT07699731 | Not Yet Recruiting

• 1 other identifier: 6046158
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 1.Complete a short anxiety questionnaire before the procedure
2. 2.Undergo ERCP with standard sedation as planned by their care team
3. 3.Complete a post-procedure questionnaire about comfort, pain, and other symptoms
4. 4.Have procedure details and outcomes recorded from medical records

Conditions

Anxiety; Biliary and Pancreatic Diseases; ERCP

Keywords

ERCP; Endoscopic retrograde cholangiopancreatography; Conscious sedation; Pre-procedural anxiety; Patient experience; STAI-Y; PRO-STEP; Upper endoscopy; Procedural sedation

Outcome Measures

Primary Outcomes (1)

• Impact of pre-procedural anxiety on patient experience of ERCP

  The primary outcome will be the impact of pre-procedural anxiety level measured by the State-Trait Anxiety Inventory (STAI-Y), on the tolerability of ERCP using conscious sedation measured by the patient- reported scale for tolerability of endoscopic procedures (PRO-STEP) and procedure cooperation measured by the Procedural Sedation Assessment Survey (PROSAS).

  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.

Secondary Outcomes (2)

• Factors Associated with Patient Experience

  baseline, pre-procedure

• Procedural Success and Early Termination

  Recorded immediate post procedure

Study Arms (1)

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.

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

Not applicable - observational study

Patients undergoing ERCP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing clinically indicated ERCP at KHSc, who are able to provide informed consent and complete study questionnaires. Participants will be enrolled prospectively during the study period.

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

Sponsors & Collaborators

• Mandip Rai: lead
• Queen's University: collaborator

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Location

Related Publications (10)

• Neilson LJ, Sharp L, Patterson JM, von Wagner C, Hewitson P, McGregor LM, Rees CJ. The Newcastle ENDOPREM: a validated patient reported experience measure for gastrointestinal endoscopy. BMJ Open Gastroenterol. 2021 Oct;8(1):e000653. doi: 10.1136/bmjgast-2021-000653.

  PMID: 34697041 BACKGROUND

• Forbes N, Chau M, Koury HF, Lethebe BC, Smith ZL, Wani S, Keswani RN, Elmunzer BJ, Anderson JT, Heitman SJ, Hilsden RJ. Development and validation of a patient-reported scale for tolerability of endoscopic procedures using conscious sedation. Gastrointest Endosc. 2021 Jul;94(1):103-110.e2. doi: 10.1016/j.gie.2020.12.038. Epub 2020 Dec 30.

  PMID: 33385464 BACKGROUND

• Leffler DA, Bukoye B, Sawhney M, Berzin T, Sands K, Chowdary S, Shah A, Barnett S. Development and validation of the PROcedural Sedation Assessment Survey (PROSAS) for assessment of procedural sedation quality. Gastrointest Endosc. 2015 Jan;81(1):194-203.e1. doi: 10.1016/j.gie.2014.07.062. Epub 2014 Oct 5.

  PMID: 25293829 BACKGROUND

• Areia M, Esposito G, Leclercq P, Romanczyk M, Zessner-Spitzenberg J, Delgado Guillena PG, Monged A, Honrubia Lopez R, Uchima H, Ruiz Ballesteros EJ, Panarese A, Reis de Oliveira LA, Afify S, Bisschops R, Ferlitsch M; External Voting Panel. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative - Update 2025. Endoscopy. 2025 Nov;57(11):1268-1297. doi: 10.1055/a-2674-4912. Epub 2025 Sep 11.

  PMID: 40934951 BACKGROUND

• Anhang Price R, Elliott MN, Zaslavsky AM, Hays RD, Lehrman WG, Rybowski L, Edgman-Levitan S, Cleary PD. Examining the role of patient experience surveys in measuring health care quality. Med Care Res Rev. 2014 Oct;71(5):522-54. doi: 10.1177/1077558714541480. Epub 2014 Jul 15.

  PMID: 25027409 BACKGROUND

• Practice Guidelines for Moderate Procedural Sedation and Analgesia 2018: A Report by the American Society of Anesthesiologists Task Force on Moderate Procedural Sedation and Analgesia, the American Association of Oral and Maxillofacial Surgeons, American College of Radiology, American Dental Association, American Society of Dentist Anesthesiologists, and Society of Interventional Radiology. Anesthesiology. 2018 Mar;128(3):437-479. doi: 10.1097/ALN.0000000000002043. No abstract available.

  PMID: 29334501 BACKGROUND

• Forbes N, Elmunzer BJ, Allain T, Parkins MD, Sheth PM, Waddell BJ, Du K, Douchant K, Oladipo O, Saleem A, Cartwright S, Chau M, Howarth M, McKay J, Nashad T, Ruan Y, Bishay K, Gonzalez-Moreno E, Meng ZW, Bass S, Bechara R, Cole MJ, Jalink DW, Mohamed R, Turbide C, Belletrutti PJ, Kayal A, Kumar PR, Hilsden RJ, Buret AG, Hookey L, Heitman SJ. Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography: The ICECAP Randomized Clinical Trial. JAMA Intern Med. 2023 Mar 1;183(3):191-200. doi: 10.1001/jamainternmed.2022.6394.

  PMID: 36689215 BACKGROUND

• Smith ZL, Mullady DK, Lang GD, Das KK, Hovis RM, Patel RS, Hollander TG, Elsner J, Ifune C, Kushnir VM. A randomized controlled trial evaluating general endotracheal anesthesia versus monitored anesthesia care and the incidence of sedation-related adverse events during ERCP in high-risk patients. Gastrointest Endosc. 2019 Apr;89(4):855-862. doi: 10.1016/j.gie.2018.09.001. Epub 2018 Sep 11.

  PMID: 30217726 BACKGROUND

• Melita G, Tripodi VF, Pallio S, Shahini E, Vitello A, Sinagra E, Facciorusso A, Mazzeo AT, Choudhury A, Dhar J, Samanta J, Maida MF. Moderate Sedation or Deep Sedation for ERCP: What Are the Preferences in the Literature? Life (Basel). 2024 Oct 15;14(10):1306. doi: 10.3390/life14101306.

  PMID: 39459606 BACKGROUND

• Karpuzcu HC, Yarbas G, Catalbas R, Atli NA, Erdogan C. The effect of pre-procedural anxiety level on the quality of upper GI endoscopy in non-sedated patients: "can the need for sedation be predicted?". Ther Adv Gastroenterol. 2025 Apr 16;18:17562848251333025. doi: 10.1177/17562848251333025. eCollection 2025.

  PMID: 40297209 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Pancreatic Diseases

Condition Hierarchy (Ancestors)

Mental Disorders; Digestive System Diseases

Central Study Contacts

Dain R Kim, MSc, MD

CONTACT

4035850249; dain.kim@queensu.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)