1. 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…
ID
Source
Brief title
Condition
- Other condition
- Miscellaneous and site unspecified neoplasms benign
- Gastrointestinal therapeutic procedures
Synonym
Health condition
Intraductaal papillair mucineus neoplasma (IPMN)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
The recurrence rate of resected malignant IPMN has been reported to be 15-40%
compared to only 8% of resected non-malignant IPMN. Among patients with
resected malignant IPMN, those who have tumor recurrence have a significantly
poorer survival rate compared to those who do not have recurrence. Multiple
studies have shown that the degree of dysplasia present at the resection margin
is a significant and independent factor contributing to recurrence after
resection of malignant IPMN.
However, the lack of evidence-based recommendations for surgical decision
making - specifically, how much additional pancreatic tissue to resect in case
of dysplasie at the resection margin - is one of the major clinical challenges
pancreatic surgeons face. Moreover, even when a clear resection margin is
obtained, lesions along the duct within the remnant that are not continuous
with the primary IPMN lesion may be missed. Studies show that approximately 20%
of patients of resected IPMN cysts are discovered to have these lesions,
referred to as skip (discontinuous) lesions. Identifying such lesions
intra-operatively may alter the surgical plan and lead to extension of
resection or sparing of suspicious tissue.
Study objective
1. 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
2. To generate a hypothesis for a subsequent randomized control trial
Study design
Prospective, Multi-center, Non-Randomized, Consecutive series Observational
study
Study burden and risks
Patients participating in the study will undergo intraoperative pancreatoscopy,
in addition to standard pancreatic resection for IPMN. The follow-up after the
operation will be according to local standards, and no additional reviews,
admission, outpatient clinic visits are required. Therefore, patients
participating in this study will have a minor burden associated with
participation.
There are no reported complications associated with IOP in the literature and
the use of IOP reduces many of the risk factors associated with conventional
per oral pancreatoscopy (ie during surgery can drain contrast medium, in
surgery can control any bleeding if necessary). Therefore, the risk of
participating in this study is very low (almost negligible).
Boston Scientific Way 100
Marlborough MA 01752-1234
US
Boston Scientific Way 100
Marlborough MA 01752-1234
US
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70652.018.19 |