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Evaluating Suspected Intraductal Papillary Mucinous Neoplasms (IPMN) With SpyGlass Pancreatoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03062124
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : August 5, 2020
Information provided by (Responsible Party):
Leena Kylanpaa, Helsinki University Central Hospital

Brief Summary:
Intraductal papillary mucinous neoplasms (IPMN) have a potential to develop into a malignant disease with varying severity. Decision making on when and how to make a therapeutic intervention is not simple. Endoscopic equipment that can enter the pancreatic duct itself can provide the much needed additional information on the cystic condition. Visual inspection, direct visual guided biopsies from the target and the cytology of the flushing fluid of the pancreatic duct may be helpful in the decision making process of when and how to treat the condition. We study whether SpyGlass pancreatoscopy brings accuracy to the diagnostic process concerning IPMNs and does it provide additional information to help make decisions about therapeutical interventions. We also document complications related to the procedure itself in the following weeks after the procedure.

Condition or disease Intervention/treatment
Intraductal Papillary Mucinous Neoplasm Procedure: SpyGlass pancreatoscopy

Detailed Description:

In this part retrospective, part prospective single-center study we look in to the patients who have undergone SpyGlass pancreatoscopy in Helsinki University Hospital in the recent years, and recruit patients continuously to obtain a significant amount of study subjects. We investigate the radiological findings and diagnoses before the SpyGlass procedure, and if ERCP (endoscopic retrograde cholangiopancreatography) has been performed, also brush cytology.

During the SpyGlass procedure we collect direct visual guided biopsies of the suspected IPMN area and the flushing liquid used in the pancreatic duct. We then compare the diagnosis given by the collected samples to the ones the patients had based on examinations before the SpyGlass pancreatoscopy.

Our SpyGlass pancreatoscopy technique is different compared to previous studies. With our equipment we are able to provide pancreatoscopy to patients, who previously have had an endoscopic stenting procedure affecting their pancreatic duct. We also collect and analyze the flushing fluid for malignant cells, which haven't been done before. With these new means we hope to get more accurate results.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluating Suspected Intraductal Papillary Mucinous Neoplasms (IPMN) With SpyGlass Pancreatoscopy
Actual Study Start Date : November 18, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Intervention Details:
  • Procedure: SpyGlass pancreatoscopy
    During the SpyGlass pancreatoscopy procedure visually guided biopsies and flushing liquid are collected from the pancreatic duct

Primary Outcome Measures :
  1. Histologic diagnosis given by the collected samples [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Influence in decision-making concerning the patients clinical management [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Post procedural complications emerged after SpyGlass pancreatoscopy [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
  • Tissue biopsies collected from suspected IPMN (Intraductal Papillary Mucinous Neoplasm) lesions
  • Flushing fluid from pancreatic duct

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients is this study are being examined or treated in Helsinki University Central Hospital for cystic lesions of the pancreas.

Inclusion Criteria:

  • Medical imaging showing cystic pancreatic lesions.
  • Medical imaging showing dilatation of the pancreatic duct

Exclusion Criteria:

- Malignancy confirmed by previous examinations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03062124

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Contact: Leena Kylänpää, MD, PhD +358 50 4272869

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Helsinki University Hospital Recruiting
Helsinki, Uusimaa, Finland, 00029
Contact: Leena Kylänpää   
Sponsors and Collaborators
Helsinki University Central Hospital
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Study Chair: Sini Vehviläinen, MD Päijänne Tavastia 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: Arto Kokkola, MD, PhD Helsinki University Central Hospital
Principal Investigator: Leena Kylänpää, MD, PhD Helsinki University Central Hospital
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Responsible Party: Leena Kylanpaa, MD, PhD, Helsinki University Central Hospital Identifier: NCT03062124    
Other Study ID Numbers: IPMN SpyGlass
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leena Kylanpaa, Helsinki University Central Hospital:
Additional relevant MeSH terms:
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