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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54888

Enrollment

Registered

2020-03-05

Start date

2020-06-26

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Intraductaal papillair mucineus neoplasma (IPMN) Intraductal Papillary Mucinous Neoplasm (IPMN)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Contraindication for pancreatoscopy Age: less than 18 years Pregnant women

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
1. 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 SpyBite* where applicable 2. Serious adverse events related to the intra-operative pancreatoscopy procedure and/or device 3. Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method (CT/EUS/other) 4. Comparison of visual and biopsy diagnosis based on exploration with SpyGlass* of the resected specimen 5. Inter-observer correspondence of visual impression of IPMN, based on intra-operative impression and on review of recorded intraoperative pancreatoscopy images/videos	—

Measure

Time frame

1. 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 SpyBite* where applicable 2. Serious adverse events related to the intra-operative pancreatoscopy procedure and/or device 3. Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method (CT/EUS/other) 4. Comparison of visual and biopsy diagnosis based on exploration with SpyGlass* of the resected specimen 5. Inter-observer correspondence of visual impression of IPMN, based on intra-operative impression and on review of recorded intraoperative pancreatoscopy images/videos

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Countries

Netherlands

Outcome results