Clinical trial NCT04580940: SpyGlass™ Discover Percutaneous
Official title: Flexible Percutaneous Transhepatic Cholangiopancreatoscopy (PTCS) in Complex Pancreaticobiliary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Diseases
Bile Duct Obstruction
Bile Duct Diseases
Keywords: Percutaneous transhepatic cholangiopancreatoscopy
spyglass discover
pancreaticobiliary disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2020-10-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with complex pancreaticobiliary disease

Brief summary: 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

Detailed description: 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:

* PTCS for tissue diagnosis in cases of surgically or pathologically-altered anatomy,
* PTCS for stone removal after surgically or pathologically-altered anatomy,
* Percutaneous rendezvous to aid ERCP after failed endoscopic cannulation,
* Percutaneous delivery of palliative intraluminal brachytherapy,
* Intra-procedural percutaneous salvage procedures when an initial route of access fails

Eligibility criteria: Inclusion Criteria:

1. Scheduled for a percutaneous transhepatic procedure to access the pancreaticobiliary anatomy that will accommodate passage of SpyGlass™ Discover Digital Catheter per local standard of practice
2. Written informed consent from patient or legally authorized representative of the patient

Exclusion Criteria:

1. Contraindication for cholangiopancreatoscopy
2. Subjects with unresolved adverse event(s) associated with prior percutaneous pancreaticobiliary ductal access
3. \<18 years of age
4. Potentially vulnerable subjects, including, but not limited to pregnant women

Primary outcomes:
measure: Achieving clinical intent of procedure as indicated
timeFrame: 1 month
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: 1 month
measure: Technical success
timeFrame: During index procedure
measure: Procedural Time
timeFrame: During index procedure
measure: Number of PTCS procedures
timeFrame: 1 month
measure: Endoscopist rating
timeFrame: During index procedure
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Brussels
country: Belgium
facility: Erasme University Hospital
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
city: Düsseldorf
country: Germany
facility: Evangelisches Krakenhaus Düsseldorf
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: NewTerritories
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
state: Somajiguda
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Ivo Boskoski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Evangelisches Krakenhaus Düsseldorf
name: Torsten Beyna, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Mason
name: Mehran Fotoohi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasme University Hospital
name: Arnaud Lemmers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prince of Wales Hospital
name: James Lau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto General Hospital, University Health Network
name: Eran Shlomovitz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asian Institute of Gastroenterology
name: Mohan Ramchandani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: