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

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03062124

Collaborator

(none)

101

Enrollment

Locations

37.4

Actual Duration (Months)

33.7

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraductal Papillary Mucinous Neoplasm	Procedure: SpyGlass pancreatoscopy

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 Design

Study Type:

Observational

Actual Enrollment :

101 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Single-operator Peroral Pancreatoscopy in Preoperative Diagnostics of Presumed Main Duct Intraductal Papillary Mucinous Neoplasms: Efficacy and Novel Insights on Complications

Actual Study Start Date :

Nov 18, 2017

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

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

Post procedural complications emerged after SpyGlass pancreatoscopy [1 year]
According to Cotton criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Malignancy confirmed by previous examinations

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsinki University Hospital	Helsinki	Uusimaa	Finland	00029
2	Skåne University Hospital	Lund		Sweden
3	Karolinska University Hospital	Stockholm		Sweden

Sponsors and Collaborators

Helsinki University Central Hospital

Investigators

Study Chair: Sini M Vehviläinen, MD, Helsinki University Central Hospital
Study Chair: Hanna Seppänen, MD, PhD, Helsinki University Central Hospital
Study Chair: Marianne Udd, MD, PhD, Helsinki University Central Hospital
Study Chair: Outi Lindström, MD, PhD, Helsinki University Central Hospital
Principal Investigator: Leena Kylänpää, MD, PhD, Helsinki University Central Hospital
Study Chair: Urban Arnelo, Karolinska University Hospital
Study Chair: Niklas Fagerström, Karolinska University Hospital
Study Chair: Roberto Valente, Karolinska University Hospital
Study Chair: Harri Mustonen, Helsinki University Central Hospital
Study Chair: Fredrik Swahn, Skane University Hospital