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

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.

Study Overview

• Status: Completed
• Conditions: Intraductal Papillary Mucinous Neoplasm
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00029
      • Helsinki University Hospital
• Sweden
  • Lund, Sweden
    • Skåne University Hospital
  • Stockholm, Sweden
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Malignancy confirmed by previous examinations

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: 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, Skåne University Hospital

Publications and helpful links

General Publications

• Tanaka M, Fernandez-del Castillo C, Adsay V, Chari S, Falconi M, Jang JY, Kimura W, Levy P, Pitman MB, Schmidt CM, Shimizu M, Wolfgang CL, Yamaguchi K, Yamao K; International Association of Pancreatology. International consensus guidelines 2012 for the management of IPMN and MCN of the pancreas. Pancreatology. 2012 May-Jun;12(3):183-97. doi: 10.1016/j.pan.2012.04.004. Epub 2012 Apr 16.
• Arnelo U, Siiki A, Swahn F, Segersvard R, Enochsson L, del Chiaro M, Lundell L, Verbeke CS, Lohr JM. Single-operator pancreatoscopy is helpful in the evaluation of suspected intraductal papillary mucinous neoplasms (IPMN). Pancreatology. 2014 Nov-Dec;14(6):510-4. doi: 10.1016/j.pan.2014.08.007. Epub 2014 Sep 27.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: February 19, 2017
• First Submitted That Met QC Criteria: February 19, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: post-ERCP pancreatitis; SpyGlass; Pancreatoscopy; Single-operator pancreatoscopy
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IPMN SpyGlass

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No