Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03729453

Intra-operative Pancreatoscopy in Patients With 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Intraductal Papillary Mucinous Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Nanjing Medical University, Nanjing, China

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Contraindication for pancreatoscopy
  • Age: less than 18 years
  • Pregnant women, evaluated per local clinical standard

Treatment and study plan

SpyGlass

Device

Visualization of main pancreatic duct with SpyGlass catheter.

Primary outcomes

  1. 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

Secondary outcomes

  1. Technical success

    Time frame: During index procedure

    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

  2. Adverse Event Evaluation

    Time frame: Five years

    Evaluate all serious adverse events related to the intraoperative pancreatoscopy procedure and/or device

  3. Recurrence

    Time frame: Five years

    Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method

  4. Comparison of visual and biopsy diagnosis

    Time frame: During index procedure

    Comparison based on exploration with Spy Glass of the resected specimen

  5. Inter-observer correspondence of visual impression of IPMN

    Time frame: During index procedure

    Based on intra-operative impression and on review of recorded pancreatoscopy images/videos

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Intra-operative Pancreatoscopy in Patients With Intraductal Papillary Mucinous Neoplasm (IPMN)

Important dates

Study start
2019
Primary completion
2022
Study completion
2027
First posted
Nov 2, 2018
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.