An observational study in Intraductal Papillary Mucinous Neoplasm, sponsored by Helsinki University Central Hospital. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by Helsinki University Central Hospital · Observational
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.
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.
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Multicenter study, patients from Helsinki University Hospital, Skåne University Hospital and Karolinska University Hospital. All patients underwent single-operator peroral pancreatoscopy due to presumed main duct IPMNs
Exclusion Criteria:
During the SpyGlass pancreatoscopy procedure visually guided biopsies and flushing liquid are collected from the pancreatic duct
Histologic diagnosis given by the collected samples
Pathologists report
Time frame: 1 year
Influence in decision-making concerning the patients clinical management
Multidisplinary meeting decision after SpyGlass
Time frame: 1 year
Post procedural complications emerged after SpyGlass pancreatoscopy
According to Cotton criteria
Time frame: 1 year
Plan to share: No
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Helsinki University Central Hospital