Establishment of Abbreviated Pancreatobiliary MRI Protocol

Not Applicable

Completed

• Conditions: Pancreas Cyst; Intraductal Papillary Mucinous Neoplasm
• Interventions: Diagnostic Test: Abbreviated PB MRI

• Registration Number: NCT03731819
• Lead Sponsor: Seoul National University Hospital

Brief Summary

This study aims to establish abbreviated PB MRI protocol for patients on regular imaging follow-up for pancreas cystic neoplasm.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-03
• Study First Submitted QC: 2018-11-03
• Study Start: 2018-11-05
• Study First Posted: 2018-11-06
• Primary Completion: 2019-11-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Study Completion: 2022-05-04
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• on follow-up for pancreas intraductal mucinous neoplasm
• OR incidentally detected pancreas cyst (equal to or larger than 1cm)
• AND scheduled for CECT or has CECT within a months
• AND sign informed consent

Exclusion Criteria

• Any absolute or relative contra-indication for contrast-enhanced MRI
• No pancreas cystic neoplasm
• History of pancreatectomy
• History of any procedure for pancreatic cyst (ablation, aspiration...) in a year
• Hemosiderosis
• Suspicion of acute pancreatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Follow-up participants	Abbreviated PB MRI	Patients who met eligibility criteria. Participants are going to undergo Abbreviated PB MRI.

Primary Outcome Measures

Name	Time	Method
Table time of Abbreviated PB MRI	1 day after PB MRI acquisition	total scan time

Secondary Outcome Measures

Name	Time	Method
In room time of Abbreviated PB MRI	1 day after PB MRI acquisition	time spent in room by participants (difference between walk-in and walk-out times)
Diagnostic confidence	6 months after participants enrollment	subjective diagnostic confidence for pancreas cystic neoplasm on five point scale
Requirement for re-examination	6 months after participants enrollment	clinical need for re-examination due to suboptimal image quality
Image quality	6 months after participants enrollment	overall image quality of Abbreviated PB MRI

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of