SpyGlass in Preoperative Diagnostics of Presumed Main Duct IPMNs: Efficacy and Novel Insights on Complications

Completed

• Conditions: Intraductal Papillary Mucinous Neoplasm

• Registration Number: NCT03062124
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

Distinguishing intraductal papillary mucinous neoplasms (IPMNs) from other pancreatic cystic lesions is essential as IPMNs bear risk of becoming malignant. Differentiating the main pancreatic duct involving IPMNs (MD-IPMNs) with imaging can be difficult. Single-operator peroral pancreatoscopy (SOPP) has shown to be a promising method offering additional information on suspected lesions in the main pancreatic duct (MD). We aimed to establish the role of SOPP in preoperative diagnostics of presumed MD-IPMNs. A secondary objective was to identify factors that contribute to SOPP-related complications.

Detailed Description

In this multicenter, partly prospective, but mostly retrospective cohort study, 101 SOPPs were performed due to presumed MD-IPMNs in three centers. As a key outcome, the rate of how often visual appearance of MD, and/or MD flushing liquid samples and biopsies taken during SOPP affected further clinical care, was determined. Secondly, post-SOPP complications according to Cotton consensus criteria, diameter of MD, use of prophylactic nonsteroidal anti-inflammatory drugs (NSAIDs) and pancreatic stents, duration of SOPP and timing of pancreatic sphincterotomy (PS) were documented.

Study Timeline

• Study First Submitted: 2017-02-19
• Study First Submitted QC: 2017-02-19
• Study First Posted: 2017-02-23
• Study Start: 2017-11-18
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Medical imaging showing suspision of IPMN,.
• Medical imaging showing dilatation of the pancreatic duct

Exclusion Criteria

• Malignancy confirmed by previous examinations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histologic diagnosis given by the collected samples	1 year	Pathologists report
Influence in decision-making concerning the patients clinical management	1 year	Multidisplinary meeting decision after SpyGlass

Secondary Outcome Measures

Name	Time	Method
Post procedural complications emerged after SpyGlass pancreatoscopy	1 year	According to Cotton criteria

Trial Locations

Locations (3)

Skåne University Hospital; 🇸🇪 Lund, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Helsinki University Hospital; 🇫🇮 Helsinki, Uusimaa, Finland