Clinical trial NCT05822635: SpyGlass Surgical Study
Official title: Intraoperative Endoscopy Using a Thin, Single-Use, Flexible Cholangiopancreatoscope
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Diseases
Bile Duct Diseases
Hepatic Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2023-04-21
Enrollment: 34
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 diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
* To identify specific surgical procedures in which intraoperative use of a thin, single use, flexible cholangiopancreatoscope suggests clinically meaningful benefit and generate a hypothesis for possible subsequent claims-supportive study

Detailed description: This case series aims to document the clinical utility of intraoperative endoscopy using a thin, disposable, flexible cholangiopancreatoscope in procedures including but not limited to:

* Evaluation of biliary lesion(s) during surgical management of common bile duct (CBD) and intrahepatic duct (IHD) strictures, with or without biopsy
* Transcystic/transcholedochal clearance of biliary stone(s)/sludge/cast with or without mechanical, electrohydraulic or laser lithotripsy
* Treatment of hepatolithiasis
* Assessment of communication between the biliary tree and the cyst in the setting of ruptured hydatid parasitic cysts or abcesses
* Visualization of intraductal papillary mucinous neoplasm (IPMN) lesion(s) with or without biopsy
* Assessment of pancreatic duct (PD) strictures in chronic pancreatitis, with or without biopsy

Eligibility criteria: Inclusion Criteria:

* Clinical indication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
* Written informed consent from patient or legally authorized representative of the patient

Exclusion Criteria:

* Contraindication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
* \<18 years of age
* Potentially vulnerable subjects, including, but not limited to pregnant women

Primary outcomes:
measure: Technical success
timeFrame: During study procedure
Secondary outcomes:
measure: Number of adverse events
timeFrame: 1 month
measure: Endoscopist rating of clinical impact of study procedure
timeFrame: During study procedure
measure: Adequate diagnostic yield
timeFrame: 1 month
measure: Endoscopist rating of device
timeFrame: During study procedure
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Lanzhou
country: China
facility: Lanzhou University No. 1 Hospital
state: Gansu
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: New Territories
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
state: Telangana
Study officials:
References: