Visualization of the Pancreas during a surgical operation in patients with cystic lesion.

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

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/02/017682

Enrollment

200

Registered

2019-02-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: SpyGlassâ?¢ Direct Visualization System (DS): SpyGlassâ?¢ DS Digital Controller is intended to provide illumination and receive, process, and output images from the SpyScopeâ?¢ DS Acces

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient scheduled for surgery for suspected MD-IPMN or Mixed IPMN within 4-6 weeks of enrollment 2. Diameter of pancreatic main duct >5mm on pre-operative MRI or CT 3. Written informed consent from patient to participate in the study, including compliance with study procedures

Exclusion criteria

Exclusion criteria: 1. Contraindication for pancreatoscopy 2. Age: less than 18 years 3. Pregnant women, evaluated per local clinical standard

Design outcomes

Primary

Measure	Time frame
The primary outcome is the rate of detection of discontinuous (skip) lesion(s) along the Main Pancreatic Duct (MPD) of patients with IPMN using intraoperative pancreatoscopy based on visual impression of IPMN and/or pancreatoscopy guided biopsies.Timepoint: Primary objectives are assessed post procedure.	—

Secondary

Measure	Time frame
Comparison of visual and biopsy diagnosis based on exploration with SpyGlassâ?¢ of the resected specimenTimepoint: Secondary objectives are assessed post procedure.;Inter-observer correspondence of visual impression of IPMN, based on intra-operative impression and on review of recorded intraoperative pancreatoscopy images/videosTimepoint: Secondary objectives are assessed post procedure.;Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method (CT/EUS/other)Timepoint: Secondary objectives are assessed post procedure;Serious adverse events related to the intra-operative pancreatoscopy procedure and/or deviceTimepoint: Secondary objectives are assessed post procedure;Technical success: Ability to (a) advance the pancreatoscope along the entire MPD length or until clinically needed, (b) to visualize the potential lesion(s) or (c) to obtain a tissue sample with SpyBiteâ?¢ where applicableTimepoint: Secondary objectives are assessed post procedure.	—

Measure

Time frame

Comparison of visual and biopsy diagnosis based on exploration with SpyGlassâ?¢ of the resected specimenTimepoint: Secondary objectives are assessed post procedure.;Inter-observer correspondence of visual impression of IPMN, based on intra-operative impression and on review of recorded intraoperative pancreatoscopy images/videosTimepoint: Secondary objectives are assessed post procedure.;Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method (CT/EUS/other)Timepoint: Secondary objectives are assessed post procedure;Serious adverse events related to the intra-operative pancreatoscopy procedure and/or deviceTimepoint: Secondary objectives are assessed post procedure;Technical success: Ability to (a) advance the pancreatoscope along the entire MPD length or until clinically needed, (b) to visualize the potential lesion(s) or (c) to obtain a tissue sample with SpyBiteâ?¢ where applicableTimepoint: Secondary objectives are assessed post procedure.

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Countries

China, India, Japan, Netherlands, Sweden, United States of America

Contacts

Public ContactDr GV Rao

Asian Institute of Gastroenterology

gvraoaig@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026