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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03062124

Enrollment

101

Registered

2017-02-23

Start date

2017-11-18

Completion date

2020-12-31

Last updated

2021-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraductal Papillary Mucinous Neoplasm

Keywords

SpyGlass, Pancreatoscopy, Single-operator pancreatoscopy, post-ERCP pancreatitis

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.

Interventions

PROCEDURESpyGlass pancreatoscopy

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Post procedural complications emerged after SpyGlass pancreatoscopy	1 year	According to Cotton criteria

Countries

Finland, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026