SpyGlass in Preoperative Diagnostics of Presumed Main Duct IPMNs: Efficacy and Novel Insights on Complications

Study Overview
=================
Brief Summary
-----------------
Distinguishing intraductal papillary mucinous neoplasms (IPMNs) from other pancreatic cystic lesions is essential as IPMNs bear risk of becoming malignant. Differentiating the main pancreatic duct involving IPMNs (MD-IPMNs) with imaging can be difficult. Single-operator peroral pancreatoscopy (SOPP) has shown to be a promising method offering additional information on suspected lesions in the main pancreatic duct (MD). We aimed to establish the role of SOPP in preoperative diagnostics of presumed MD-IPMNs. A secondary objective was to identify factors that contribute to SOPP-related complications.

Detailed Description
-----------------
In this multicenter, partly prospective, but mostly retrospective cohort study, 101 SOPPs were performed due to presumed MD-IPMNs in three centers. As a key outcome, the rate of how often visual appearance of MD, and/or MD flushing liquid samples and biopsies taken during SOPP affected further clinical care, was determined. Secondly, post-SOPP complications according to Cotton consensus criteria, diameter of MD, use of prophylactic nonsteroidal anti-inflammatory drugs (NSAIDs) and pancreatic stents, duration of SOPP and timing of pancreatic sphincterotomy (PS) were documented.

Official Title
-----------------
Single-operator Peroral Pancreatoscopy in Preoperative Diagnostics of Presumed Main Duct Intraductal Papillary Mucinous Neoplasms: Efficacy and Novel Insights on Complications

Conditions
-----------------
Intraductal Papillary Mucinous Neoplasm

Intervention / Treatment
-----------------
* Procedure: SpyGlass pancreatoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical imaging showing suspision of IPMN,. Medical imaging showing dilatation of the pancreatic duct Exclusion Criteria: - Malignancy confirmed by previous examinations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: SpyGlass pancreatoscopy|During the SpyGlass pancreatoscopy procedure visually guided biopsies and flushing liquid are collected from the pancreatic duct|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic diagnosis given by the collected samples | Pathologists report | 1 year | 
| Influence in decision-making concerning the patients clinical management | Multidisplinary meeting decision after SpyGlass | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post procedural complications emerged after SpyGlass pancreatoscopy | According to Cotton criteria | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SpyGlass, Pancreatoscopy, Single-operator pancreatoscopy, post-ERCP pancreatitis