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To document the clinical utility of percutaneous cholangiopancreatoscopy using a thin, disposable, flexible endoscope for evaluation and treatment of complex pancreaticobiliary disease in a prospective, multi-center case series
This case series aims to illustrate the clinical utility of percutaneous transhepatic cholangiopancreatoscopy using a thin, disposable, flexible endoscope performed by gastroenterological endoscopists and/or interventional radiologists in procedures including but not limited to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with complex pancreaticobiliary disease | All subjects will undergo the percutaneous transhepatic cholangiopancreatoscopy with the SpyGlass Discover System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpyGlass™ Discover Digital System | Device | Observational, prospective, registry study for the clinical utility of the SpyGlass Discover digital catheter during a PTCS procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achieving clinical intent of procedure as indicated | Physicians will report achieving clinical success by recording the completed procedures compared to procedures planned by 30 days (+/- 3 days) after index PTCS. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Serious adverse events related to the study device, accessory devices used through the working channel of the SpyGlass™ Discover Digital Catheter or the cholangiopancreatoscopy portion of the PTCS procedure(s). | 1 month |
| Technical success |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with complex pancreaticobiliary disease
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| Name | Affiliation | Role |
|---|---|---|
| Ivo Boskoski, MD, PhD | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Torsten Beyna, MD, PhD | Evangelisches Krakenhaus Düsseldorf | Principal Investigator |
| Mehran Fotoohi, MD, PhD | Virginia Mason | Principal Investigator |
| Arnaud Lemmers, MD, PhD | Erasme University Hospital | Principal Investigator |
| James Lau, MD, PhD | Prince of Wales Hospital | Principal Investigator |
| Eran Shlomovitz, MD, PhD | Toronto General Hospital, University Health Network | Principal Investigator |
| Mohan Ramchandani, MD, PhD | Asian Institute of Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States | ||
| Erasme University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39184059 | Derived | Boskoski I, Beyna T, Lau JY, Lemmers A, Fotoohi M, Ramchandani M, Pontecorvi V, Peetermans J, Shlomovitz E. Efficacy and safety of a single-use cholangioscope for percutaneous transhepatic cholangioscopy. Endosc Int Open. 2024 Aug 23;12(8):E981-E988. doi: 10.1055/a-2366-2265. eCollection 2024 Aug. | |
| 38879045 | Derived |
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| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D001660 | Biliary Tract Diseases |
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Rate at which SpyGlass™ Discover digital catheter can be advanced to the target lesion or stone(s) and visualize the target |
| During index procedure |
| Procedural Time | Time elapsed between first insertion to last removal of the SpyGlass™ Discover digital catheter | During index procedure |
| Number of PTCS procedures | Number of PTCS procedures required to achieve clinical success until the end of follow-up | 1 month |
| Endoscopist rating | Endoscopist rating of the following attributes when using SpyGlass™ Discover Digital Catheter compared to marketed reusable scopes Ability to complete the procedure Ability to retroflex Ability to selectively advance into targeted ducts Ability to obtain targeted biopsies Ability to grasp stones Ability to guide lithotripsy Ability to suction Ability to irrigate Ability to advance accessories through scope channel Image quality | During index procedure |
| Brussels |
| 1070 |
| Belgium |
| Toronto General Hospital, University Health Network | Toronto | Ontario | M5G2N2 | Canada |
| Evangelisches Krakenhaus Düsseldorf | Düsseldorf | 40217 | Germany |
| Prince of Wales Hospital | Shatin | NewTerritories | 999077 | Hong Kong |
| Asian Institute of Gastroenterology | Hyderabad | Somajiguda | 500-082 | India |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | 00168 | Italy |
| Aihara H, Othman MO, Jawaid SA, Gorgun E, Sharma NR, Siddiqui UD, Peetermans JA, Rousseau MJ, Nishimura M. A multicenter, retrospective study of a through-the-needle injection-capable electrosurgical knife for endoscopic submucosal dissection. Gastrointest Endosc. 2024 Dec;100(6):1034-1042. doi: 10.1016/j.gie.2024.06.011. Epub 2024 Jun 13. |