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

NCT ID: NCT03062124

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-18
• Study Completion Date: 2020-12-31

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.

Conditions

Intraductal Papillary Mucinous Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

SpyGlass pancreatoscopy

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Malignancy confirmed by previous examinations

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Leena Kylanpaa

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sini M Vehviläinen, MD

Role: STUDY_CHAIR

Helsinki University Central Hospital

Hanna Seppänen, MD, PhD

Role: STUDY_CHAIR

Helsinki University Central Hospital

Marianne Udd, MD, PhD

Role: STUDY_CHAIR

Helsinki University Central Hospital

Outi Lindström, MD, PhD

Role: STUDY_CHAIR

Helsinki University Central Hospital

Leena Kylänpää, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Urban Arnelo

Role: STUDY_CHAIR

Karolinska University Hospital

Niklas Fagerström

Role: STUDY_CHAIR

Karolinska University Hospital

Roberto Valente

Role: STUDY_CHAIR

Karolinska University Hospital

Harri Mustonen

Role: STUDY_CHAIR

Helsinki University Central Hospital

Fredrik Swahn

Role: STUDY_CHAIR

Skane University Hospital

Locations

Helsinki University Hospital

Helsinki, Uusimaa, Finland

Skåne University Hospital

Lund, , Sweden

Karolinska University Hospital

Stockholm, , Sweden

Countries

Finland; Sweden

References

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.

Reference Type: BACKGROUND

PMID: 25287157 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22687371 (View on PubMed)

Other Identifiers

IPMN SpyGlass

Identifier Type: -

Identifier Source: org_study_id