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The purpose of this study is to document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System (DVS) throughout the AMEA (Asia, Middle-East, Africa) region when used per standard of practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indeterminate strictures or undefined filling defects |
| ||
| Biliary stone cases |
| ||
| Other indications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERCP (Endoscopic Retrograde Cholangiopancreatography) | Procedure | ERCP procedure will be performed to visualize bile ducts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success for indeterminate strictures or undefined filling defects | For indeterminate strictures or undefined filling defects cases procedural success is defined as 1) ability to visualize stricture or defect, and 2) ability to provide visual impression of malignancy, and 3) when applicable, ability to obtain SpyBite biopsy adequate for histology | Procedure - the average expected duration of the procedure is 1.5 hours |
| Procedural success for biliary stone cases | For biliary stone cases procedural success is defined as 1) ability to visualize the stone(s), and 2) ability to successfully initiate stone fragmentation, and 3) ability to achieve stone clearance in one or more SpyGlass procedures. | Procedure - the average expected duration of the procedure is 1.5 hours |
| Procedural success for other indications | For other indications procedural success is defined as ability to establish diagnosis and /or complete therapy in the following categories: 1) pre-operative assessment of extent of peri-ampullary and biliary tumors, 2) selective guidewire placement, 3) assessment of unexplained hemobilia, 4) assessment of portal biliopathy, 5) assessment of intraductal biliary ablation therapy, 6) extraction of migrated stents, or 7) other. | Procedure - the average expected duration of the procedure is 1.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure | Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit. | Procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients seen at an investigational site during the enrollment period
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| Name | Affiliation | Role |
|---|---|---|
| Benedict Devereaux | Royal Brisbane and Women's Hospital | Principal Investigator |
| James Lau | Prince of Wales Hospital | Principal Investigator |
| Randhir Sud | Institute of Digestive & Hepatobiliary Sciences | Principal Investigator |
| Saad Niaz | Civil Hospital Karachi | Principal Investigator |
| Abdulrahman Aljebreen | King Khalid University Hospital | Principal Investigator |
| Ang Tiing Leong | Changi General Hospital Pte Ltd. | Principal Investigator |
| Jorg Reichenberger | Netcare Unitas Hospital | Principal Investigator |
| Jong Moon | Soon Chun Hyang University | Principal Investigator |
| Rungsun Rerknimitr | King Chulalongkorn Memorial Hospital | Principal Investigator |
| Ichiro Yasuda |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia | ||
| Royal Adelaide Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31250408 | Derived | Maydeo AP, Rerknimitr R, Lau JY, Aljebreen A, Niaz SK, Itoi T, Ang TL, Reichenberger J, Seo DW, Ramchandani MK, Devereaux BM, Lee JK, Goenka MK, Sud R, Nguyen NQ, Kochhar R, Peetermans J, Goswamy PG, Rousseau M, Bhandari SP, Angsuwatcharakon P, Tang RSY, Teoh AYB, Almadi M, Lee YN, Moon JH; SpyGlass AMEA Registry Group. Cholangioscopy-guided lithotripsy for difficult bile duct stone clearance in a single session of ERCP: results from a large multinational registry demonstrate high success rates. Endoscopy. 2019 Oct;51(10):922-929. doi: 10.1055/a-0942-9336. Epub 2019 Jun 27. |
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Tissue acquisition in the bile ducts
| SpyGlass DVS and SpyGlass Digital Simple (DS) | Device | Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed |
|
| Impact of SpyGlass procedure on suspected diagnosis based on prior ERCP | Procedure - the average expected duration of the procedure is 1.5 hours |
| Evaluation of impact of use of antibiotics on incidence of SAEs related to the device and/or procedure. | Procedure - the average expected duration of the procedure is 1.5 hours |
| For patients undergoing SpyBite biopsy: correlation between number of biopsies and conclusive histopathology of SpyBite biopsies. | Assessment Detail: Endpoint determined for all patients in whom SpyBite biopsy was taken and observed image features were reported. Observed image features include the following categories: None, Growth, Stricture, Hyperplasia, Ulceration, Mass, Dilated tortuous vessels, Papillary or villous projections, Intraductal nodules, Mucus. | Procedure to 6 months |
| For patients undergoing stone management: number of SpyGlass procedures needed to reach stone clearance. | Procedure - the average expected duration of the procedure is 1.5 hours |
| For patients undergoing stone management: correlation between stone size and ability to reach stone clearance in one SpyGlass session. | Procedure - the average expected duration of the procedure is 1.5 hours |
| For patients undergoing stone management: incidence of visualization of stones not suspected during previous ERCP. | Procedure - the average expected duration of the procedure is 1.5 hours |
| Teikyo University Mizonokuchi Hospital |
| Principal Investigator |
| Arthur J. Kaffes | Royal Prince Alfred Hospital, Sydney, Australia | Principal Investigator |
| Nam Q. Nguyen | Royal Adelaide Hospital | Principal Investigator |
| Amit Maydeo | Baldota Institute of Digestive Sciences | Principal Investigator |
| Mohan Ramchandani | Asian Institute of Gastroenterology | Principal Investigator |
| Mahesh Goenka | Apollo Gleneagles Hospital | Principal Investigator |
| Professor R. Kochhar | Postgraduate Institute of Medical Education & Research | Principal Investigator |
| Takao Itoi | Tokyo Medical University | Principal Investigator |
| Masayuki Kitano | Kinki University School of Medicine | Principal Investigator |
| Jong K. Lee | Samsung Medical Center | Principal Investigator |
| Dongwan Seo | Asan Medical Center | Principal Investigator |
| Adelaide |
| Australia |
| Royal Prince Alfred Hospital | Newtown | Australia |
| Prince of Wales Hospital | Shatin | Hong Kong |
| Apollo Gleneagles Hospitals Kolkata | Kolkata | West Bengal | 70054 | India |
| Postgraduate Institute of Medical Education & Research | Chandigarh | India |
| Medanta -The Medicity Institute of Digestive & Hepatobiliary Sciences | Gurgaon | India |
| Asian Institute of Gastroenterology | Hyderabad | India |
| Baldota Institute of Digestive Sciences | Pārel | 400012 | India |
| Teikyo University Mizonokuchi Hospital | Kawasaki | Japan |
| Kinki University School of Medicine | Ōsaka-sayama | Japan |
| Tokyo Medical University | Tokyo | Japan |
| Civil Hospital- Karachi | Karachi | Pakistan |
| King Khalid University Hospital | Riyadh | Saudi Arabia |
| Changi General Hospital Pte Ltd. | Singapore | Singapore |
| Netcare Unitas Hospital | Centurion | South Africa |
| Soon Chun Hyang University Bucheon Hospital | Bucheon-si | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| King Chulalongkorn Memorial Hospital | Bangkok | 10330 | Thailand |
| ID | Term |
|---|---|
| D006431 | Hemobilia |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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