The aim of this study is to prospectively assess the benefits and effectiveness of non-complex gallstone clearancefluoroscopy / radiation-free direct solitary cholangioscopy (DSC) comparing the SpyGlass * system to non-complex biliary stone…
ID
Source
Brief title
Condition
- Bile duct disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Complete stone clearance by extraction of bile duct stones from the common bile
duct (CBD) into duodenum as determined by
fluoroscopy free cholangioscopy in the DSC arm and by cholangiography in the
ERC arm.
Secondary outcome
Evaluation of occurrence of SAEs between DSC arm vs ERC arm
radiation exposure between DSC arm vs ERC arm
Duration procedure DSC arm vs ERC arm
Background summary
A hybrid endoscopic/radiological procedure, endoscopic retrograde
cholangio-pancreatography (ERCP), remains the predominant diagnostic and
therapeutic modality. Given the inevitable evolution of technology, it is
possible in the future, that as with other GI luminal organs, direct endoscopic
evaluation of the bile duct with cholangioscopy may replace cholangiography for
the evaluation and management of at least some kinds of biliary disease.
Non-complex biliary stone disease represents a potential such disease process,
suitable for study.
Study objective
The aim of this study is to prospectively assess the benefits and effectiveness
of non-complex gallstone clearance
fluoroscopy / radiation-free direct solitary cholangioscopy (DSC) comparing the
SpyGlass * system to non-complex biliary stone clearance using standard
endoscopic retrograde cholangiography (ERC).
Study design
A total of 250 patients will be randomized on a 1:1 ratio. Block randomization
through an
online database system will be used. Randomization will be stratified by study
center. Prior
to randomization, each participating endoscopist at each of the participating
centers must
perform up to 10 Roll-in cases. These roll-in cases will not count towards the
enrollment
ceiling of 250 cases.
* Prospective
* Consecutive cases
* Multi-center
* Randomized 1:1 ratio:
o Group A (ERC arm): Clearance of bile duct stones using standard-of-practice
ERCP techniques
o Group B (DSC arm): Clearance of bile duct stones using DSC techniques
o Block-randomization by site
* Non-inferiority hypothesis
* Validation of stone clearance by ERC in DSC arm and by DSC in ERC arm.
Intervention
Cross-over study wherein arm A the non-complex gallstones are first removed
with solitary cholangioscopy (DSC) using the SpyGlass * and clearance is
checked with endoscopic retrograde cholangiography (ERC) and in arm B the
non-complex gallstones are first removed by standard endoscopic retrograde
cholangiography (ERC) and removal is checked with solitary cholangioscopy (DSC)
(SpyGlass *).
Study burden and risks
Nature and extent of burden:
* Prior to the procedure:
Demography; Non-invasive imaging results; Medical history; Results
of blood tests In the practice/clinic of your doctor
* During the procedure:
Realization of the cannulation part of the procedure;
Number and size of the stones that are removed;
The total exposure of the patient to radiation;
The volume of contrast fluid used during the procedure;
Total number of additional devices/resources used during the procedure;
The result of the procedure; stones removed yes or no;
Assessment of serious side effects
* After the procedure (24 hours after procedure): Telephone assessment
of serious adverse event
* Follow-up visits (7 days after the procedure): Telephone
assessment of serious adverse event
* End of the study (30 days after the procedure): Telephone assessment
of serious adverse event
Possible risks of your participation
Risks have been associated with ERCP procedures including but not limited to:
* Pancreatitis
* Infection
* Perforation
* Bleeding
* Allergic reaction to contrast fluid
Patients participating in this study run the same risks as all patients who
undergo a procedure with the SpyGlass * DS but who do not participate in the
study.
The potential risks and side effects associated with the SpyScope * DS Access
and Delivery catheter include:
* Pancreatitis
* Light pancreatitis
* Self-restricted pancreatitis
* Stomach ache
* Persistent DSC-related bacteremia
* Cholangitis
* Unexpected hospitalization
* Fever
* Perforation
* Light perforation
* Bleeding after EST
* Self-restricted abdominal pain
* Asymptomatic amylasemia
* Bleeding
* Hemobilia
* Aspiration pneumonia
* Infection
The potential risks and side effects associated with the SpyGlass * Retrieval
Basket include:
* Pancreatitis after ERC
* Cholangitis
* Bleeding
* Broken basket and impaction
There may also be other risks or side effects that are currently unknown.
You can ask your doctor about the risks of participating in this study. Your
doctor may also ask you to sign other necessary consent forms for the
procedures you are undergoing.
Risks of pregnancy in this study
Pregnant women and women who intend to become pregnant during the study are
excluded from this study. This procedure has not been studied in pregnant
women. There may be extra risks for you (or for your embryo / fetus) if you
become pregnant or if you are breast-feeding. Such extra risks are not known at
this time. Tell your doctor immediately if you are pregnant or become pregnant
while participating in this study.
Possible advantages and disadvantages of your participation
You may not receive a direct benefit from your participation in this study.
However, medical science and future test subjects can benefit from your
participation.
Boston Scientific Way 300
Marlborough MA 01752-1234
US
Boston Scientific Way 300
Marlborough MA 01752-1234
US
Listed location countries
Age
Inclusion criteria
* 18 years or older
* Abdominal pain consistent with choledocholithiasis
* Abnormal LFTs
* Non-complex biliary stone disease
Exclusion criteria
* Potentially vulnerable subjects, including but not limited to pregnant women
and subjects in whom an endoscopic procedure is contraindicated.
* Location of the stones in intrahepatic ducts, cystic duct or proximal to
strictures
* Bile duct stricture noted distal to stone on MRCP, which would make
extraction without lithotripsy impossible.
* Ongoing cholangitis at time of randomization, manifested by fever with
tachycardia and hypotension or evidence of pus at the ampulla
* Patients with prior biliary sphincterotomy
* Patients with Primary Sclerosing Cholangitis (PSC)
* Acute pancreatitis
* Surgically altered gastro-duodenal luminal anatomy other than prior Billroth
I Reconstruction
* Coagulopathy or ongoing need for anti-coagulation
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03421340 |
| CCMO | NL67502.078.19 |