Clinical trial NCT03062124: SpyGlass in Preoperative Diagnostics of Presumed Main Duct IPMNs: Efficacy and Novel Insights on Complications
Official title: Single-operator Peroral Pancreatoscopy in Preoperative Diagnostics of Presumed Main Duct Intraductal Papillary Mucinous Neoplasms: Efficacy and Novel Insights on Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraductal Papillary Mucinous Neoplasm
Keywords: SpyGlass
Pancreatoscopy
Single-operator pancreatoscopy
post-ERCP pancreatitis
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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

Primary outcomes:
measure: Histologic diagnosis given by the collected samples
timeFrame: 1 year
measure: Influence in decision-making concerning the patients clinical management
timeFrame: 1 year
Secondary outcomes:
measure: Post procedural complications emerged after SpyGlass pancreatoscopy
timeFrame: 1 year
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Sini M Vehviläinen, MD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Hanna Seppänen, MD, PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Marianne Udd, MD, PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Outi Lindström, MD, PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Leena Kylänpää, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Urban Arnelo
role: STUDY_CHAIR
affiliation: Karolinska University Hospital
name: Niklas Fagerström
role: STUDY_CHAIR
affiliation: Karolinska University Hospital
name: Roberto Valente
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Harri Mustonen
role: STUDY_CHAIR
affiliation: Skane University Hospital
name: Fredrik Swahn
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.