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Completed

NCT Number: NCT03062124

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

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.

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Key information

Conditions

Intraductal Papillary Mucinous Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Hospital, Helsinki, Uusimaa, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Malignancy confirmed by previous examinations

Treatment and study plan

SpyGlass pancreatoscopy

Procedure

During the SpyGlass pancreatoscopy procedure visually guided biopsies and flushing liquid are collected from the pancreatic duct

Primary outcomes

  1. Histologic diagnosis given by the collected samples

    Time frame: 1 year

    Pathologists report

  2. Influence in decision-making concerning the patients clinical management

    Time frame: 1 year

    Multidisplinary meeting decision after SpyGlass

Secondary outcomes

  1. Post procedural complications emerged after SpyGlass pancreatoscopy

    Time frame: 1 year

    According to Cotton criteria

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 23, 2017
Registry last updated
May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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