NCT03062124

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

November 18, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

3.1 years

First QC Date

February 19, 2017

Last Update Submit

May 18, 2021

Conditions

Intraductal Papillary Mucinous Neoplasm

Keywords

SpyGlassPancreatoscopySingle-operator pancreatoscopypost-ERCP pancreatitis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Post procedural complications emerged after SpyGlass pancreatoscopy

    1 year

Interventions

SpyGlass pancreatoscopyPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • \- Malignancy confirmed by previous examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Helsinki University Hospital

Helsinki, Uusimaa, 00029, Finland

Location

Skåne University Hospital

Lund, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 25287157BACKGROUND

  • 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.

    PMID: 22687371BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

* Tissue biopsies collected from suspected IPMN (Intraductal Papillary Mucinous Neoplasm) lesions * Flushing fluid from pancreatic duct

Study Officials

  • Sini M Vehviläinen, MD

    Helsinki University Central Hospital

    STUDY CHAIR

  • Hanna Seppänen, MD, PhD

    Helsinki University Central Hospital

    STUDY CHAIR

  • Marianne Udd, MD, PhD

    Helsinki University Central Hospital

    STUDY CHAIR

  • Outi Lindström, MD, PhD

    Helsinki University Central Hospital

    STUDY CHAIR

  • Leena Kylänpää, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

  • 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

    Skane University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 19, 2017

First Posted

February 23, 2017

Study Start

November 18, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 20, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)SE(2)