Intraductal Papillary Mucinous NeoplasmNCT03729453
Intra-operative Pancreatoscopy in Patients With IPMN
An observational study of Intraductal Papillary Mucinous Neoplasm, run by Boston Scientific Corporation at 8 sites in 6 countries.
Trial summary
To demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas; to generate a hypothesis for a subsequent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraductal Papillary Mucinous Neoplasm
- What is being tested?
- SpyGlass
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 20 Mar 2019to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for surgery for suspected MD-IPMN or Mixed IPMN resection.
Who may be able to join
- Patient scheduled for surgery for suspected MD-IPMN or Mixed IPMN within 4-6 weeks of enrollment
- Diameter of pancreatic main duct >5mm on pre-operative MRI or CT
- Written informed consent from patient to participate in the study, including compliance with study procedures
Who cannot join
- Contraindication for pancreatoscopy
- Age: less than 18 years
- Pregnant women, evaluated per local clinical standard
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
United States3 sites
Johns Hopkins Hospital University
Baltimore, Maryland, 21287
University of Colorado Hospital
Denver, Colorado, 80045
Indiana University Health
Indianapolis, Indiana, 46202
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, 210029
About this study
Official title: Intra-operative Pancreatoscopy in Patients With Intraductal Papillary Mucinous Neoplasm (IPMN)
To demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas; to generate a hypothesis for a subsequent randomized control trial.
Read the detailed description
The primary objective of this study is to demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas. A secondary study objective is to generate a hypothesis for a subsequent randomized controlled trial comparing diagnostic accuracy of intra-operative pancreatoscopy and SpyBite™ with the diagnostic accuracy of intra-operative frozen section in patients undergoing resection
- Conditions
- Intraductal Papillary Mucinous Neoplasm
- Being tested
- SpyGlass
- Keywords
- IPMN, SpyGlass, Pancreatoscopy, Intraductal Papillary Mucinous Neoplasm, Intraoperative, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpyGlassDevice
Visualization of main pancreatic duct with SpyGlass catheter.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Pancreatoscopy | All subjects will undergo the intraoperative pancreatoscopy with SpyGlass procedure. Receives: Device: SpyGlass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of detection of discontinuous (skip) lesions along the main pancreatic duct
Rate of detection of discontinuous (skip) lesions along the main pancreatic duct of patients with IPMN using intraoperative pancreatoscopy based on visual impression of IPMN and/or pancreatoscopy guided biopsies
Measured: During index procedure
Secondary outcomes (5)
Technical success
Ability to advance the pancreatoscope along the entire main pancreatic duct length or until clinically needed; to visualize the potential lesion(s); or to obtain a tissue sample with SpyBite where applicable
Measured: During index procedure
Adverse Event Evaluation
Evaluate all serious adverse events related to the intraoperative pancreatoscopy procedure and/or device
Measured: Five years
Recurrence
Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method
Measured: Five years
Comparison of visual and biopsy diagnosis
Comparison based on exploration with Spy Glass of the resected specimen
Measured: During index procedure
Inter-observer correspondence of visual impression of IPMN
Based on intra-operative impression and on review of recorded pancreatoscopy images/videos
Measured: During index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start20 Mar 2019
- Primary completion11 Aug 2022
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intraductal Papillary Mucinous NeoplasmStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco Del Chiaro, MD, Principal investigator, University of Colorado, DenverG.V. Rao, MD, Principal investigator, Asian Institute of Gastroenterology, IndiaRichard Burkhart, MD, Principal investigator, Johns Hopkins UniversityMarc Besselink, MD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Yi Miao, MD, Principal investigator, Nanjing Medical UniversitySohei Satoi, MD, Principal investigator, Kansai Medical UniversityUrban Arnelo, MD, Principal investigator, University Hospital, UmeåChristian Schmidt, MD, Principal investigator, Indiana University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729453
- Sponsor's protocol ID
- E7107
- Status last verified
- Jul 2026
- First submitted
- 1 Nov 2018
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Arnelo U, Valente R, Besselink MG, Schmidt CM, Sherman S, Rao GV, Burkhart RA, Miao Y, Satoi S, Voermans RP, Modak S, Edmundowicz S, Busch OR, Lafaro KJ, Wei J, Peetermans JA, Rousseau MJ, Del Chiaro M; Intraoperative Pancreatoscopy Study Group. Value of Intraoperative Pancreatoscopy in Patients Undergoing Resection for Main-Duct Intraductal Papillary Mucinous Neoplasm: Thirty-Day Follow-Up of a Prospective International Study. Ann Surg Open. 2026 Jan 2;7(1):e638. doi: 10.1097/AS9.0000000000000638. eCollection 2026 Mar.
PubMed 41890524Grewal M, Habib JR, Paluszek O, Cohen SM, Wolfgang CL, Javed AA. The Role of Intraoperative Pancreatoscopy in the Surgical Management of Intraductal Papillary Mucinous Neoplasms: A Scoping Review. Pancreas. 2024 Mar 1;53(3):e280-e287. doi: 10.1097/MPA.0000000000002294. Epub 2024 Jan 26.
PubMed 38277399
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative Pancreatoscopy in Patients With Intraductal Papillary Mucinous Neoplasm (IPMN)
- ClinicalTrials.gov ID
- NCT03729453
- Acronym / sponsor ID
- E7107
- Conditions
- Intraductal Papillary Mucinous Neoplasm
- Keywords
- IPMN, SpyGlass, Pancreatoscopy, Intraductal Papillary Mucinous Neoplasm, Intraoperative, Surgical
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas; to generate a hypothesis for a subsequent randomized control trial.
Detailed description
The primary objective of this study is to demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas. A secondary study objective is to generate a hypothesis for a subsequent randomized controlled trial comparing diagnostic accuracy of intra-operative pancreatoscopy and SpyBite™ with the diagnostic accuracy of intra-operative frozen section in patients undergoing resection
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Pancreatoscopy | – | Device: SpyGlassAll subjects will undergo the intraoperative pancreatoscopy with SpyGlass procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for surgery for suspected MD-IPMN or Mixed IPMN resection.
Key inclusion criteria (3 listed)
- Patient scheduled for surgery for suspected MD-IPMN or Mixed IPMN within 4-6 weeks of enrollment
- Diameter of pancreatic main duct >5mm on pre-operative MRI or CT
- Written informed consent from patient to participate in the study, including compliance with study procedures
Key exclusion criteria (3 listed)
- Contraindication for pancreatoscopy
- Age: less than 18 years
- Pregnant women, evaluated per local clinical standard
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpyGlassVisualization of main pancreatic duct with SpyGlass catheter. | Device | Intraoperative Pancreatoscopy |
Primary outcome
Rate of detection of discontinuous (skip) lesions along the main pancreatic duct
Time frame: During index procedure
Rate of detection of discontinuous (skip) lesions along the main pancreatic duct of patients with IPMN using intraoperative pancreatoscopy based on visual impression of IPMN and/or pancreatoscopy guided biopsies
5 secondary outcomes
Technical success
Time frame: During index procedure
Adverse Event Evaluation
Time frame: Five years
Recurrence
Time frame: Five years
Comparison of visual and biopsy diagnosis
Time frame: During index procedure
Inter-observer correspondence of visual impression of IPMN
Time frame: During index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Derived from this study: PubMed 41890524Arnelo U, Valente R, Besselink MG, Schmidt CM, Sherman S, Rao GV, Burkhart RA, Miao Y, Satoi S, Voermans RP, Modak S, Edmundowicz S, Busch OR, Lafaro KJ, Wei J, Peetermans JA, Rousseau MJ, Del Chiaro M; Intraoperative Pancreatoscopy Study Group. Value of Intraoperative Pancreatoscopy in Patients Undergoing Resection for Main-Duct Intraductal Papillary Mucinous Neoplasm: Thirty-Day Follow-Up of a Prospective International Study. Ann Surg Open. 2026 Jan 2;7(1):e638. doi: 10.1097/AS9.0000000000000638. eCollection 2026 Mar.
- Derived from this study: PubMed 38277399Grewal M, Habib JR, Paluszek O, Cohen SM, Wolfgang CL, Javed AA. The Role of Intraoperative Pancreatoscopy in the Surgical Management of Intraductal Papillary Mucinous Neoplasms: A Scoping Review. Pancreas. 2024 Mar 1;53(3):e280-e287. doi: 10.1097/MPA.0000000000002294. Epub 2024 Jan 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Del Chiaro, MD principal investigator
University of Colorado, Denver
G.V. Rao, MD principal investigator
Asian Institute of Gastroenterology, India
Richard Burkhart, MD principal investigator
Johns Hopkins University
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraductal Papillary Mucinous Neoplasm, run by Boston Scientific Corporation at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, China, India, Japan, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of detection of discontinuous (skip) lesions along the main pancreatic duct (time frame: During index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03729453, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.