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Non-Complex Biliary Stones DSC vs ERC

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ClinicalTrials.gov Identifier: NCT03421340
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
To prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (DSC) utilizing the SpyGlass™ system with non-complex biliary stone clearance using standard endoscopic retrograde cholangiography (ERC).

Condition or disease Intervention/treatment Phase
Biliary Stones Device: DSC Device: ERC Not Applicable

Detailed Description:
The objective of this study is to prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (DSC) utilizing the SpyGlass™ system with non-complex biliary stone clearance using standard endoscopic retrograde cholangioscopy (ERC).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective, Multi-center, Randomized Controlled Study Comparing Endoscopic Clearance of Non-Complex Biliary Stones Using Fluoroscopy/Radiation-Free Direct Solitary Cholangioscopy (DSC) to Standard of Care Endoscopic Retrograde Cholangiography (ERC)
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

Arm Intervention/treatment
ERC Arm
After screening examination and confirmed presence of non-complex bile duct stone by image, patients will be randomly assigned by stratified randomization to Electroscopic Retrograde Cholangioscopy (ERC) treatment.
Device: ERC
Standard of care stone removal with fluoroscopy.
Other Name: Endoscopic Retrograde Cholangiography

DSC Arm
After screening examination and confirmed presence of non-complex bile duct stone by imagine, patients will be randomly assigned by stratified randomization to fluoroscopy/radiation-free direct solitary cholangioscopy (DSC).
Device: DSC
Stone removal without fluoroscopy using the SpyGlass device.
Other Name: Direct Solitary Cholangioscopy




Primary Outcome Measures :
  1. Complete stone clearance [ Time Frame: 2 years ]
    Prospectively compare DSC vs. ERC


Secondary Outcome Measures :
  1. Adverse event evaluation [ Time Frame: 2 years ]
    To evaluate all SAEs including death, severity, onset, time to resolution.

  2. Radiation Exposure [ Time Frame: 2 years ]
    Measure of radiation exposure from duodenoscope in to completion of stone clearance.

  3. Duration of Procedure [ Time Frame: 2 years ]
    Defined as time from duodenoscope in to completion of stone clearance.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years or older
  2. Abdominal pain consistent with choledocholithiasis (procedure possible within 72 hours of onset of symptoms and imaging suggesting choledocholithiasis, contingent on persistent abdominal pain)
  3. Abnormal LFTs
  4. Non-complex biliary stone disease, defined as 5 or fewer stones in the common bile or common hepatic duct with largest stone no larger than 10 mm in size. If stones not seen on imaging (US, CT) the bile duct diameter should be ≤12 mm*

    * Given the poor sensitivity (approximately 20%) for biliary stones of CT and US, the diameter of the dilated CBD is used as a surrogate for largest stone diameter

  5. Availability of non-invasive imaging to determine the diameter of the bile duct and number and size of bile duct stones if visible on imaging

    1. If probability of stones is high per investigator assessment based on ASGE criteria, any standard of practice imaging modality (eg. abdominal US) is acceptable.
    2. If the probability of stones is either intermediate or low per investigator assessment based on ASGE criteria, MRCP or EUS imaging is required to confirm presence of stones.
  6. Willing and able to comply with the study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

  1. Potentially vulnerable subjects, including but not limited to pregnant women and subjects in whom an endoscopic procedure is contraindicated
  2. Location of the stones in intrahepatic ducts, cystic duct or proximal to strictures
  3. Bile duct stricture noted distal to stone on MRCP, which would make extraction without lithotripsy impossible
  4. Ongoing cholangitis at time of randomization, manifested by fever with tachycardia and hypotension or evidence of pus at the ampulla
  5. Patients with prior biliary sphincterotomy
  6. Patients with Primary Sclerosing Cholangitis (PSC)
  7. Acute pancreatitis, defined as abdominal pain and serum concentration of pancreatic enzymes [lipase (required), amylase (optional)] three or more times the upper limit of normal
  8. Surgically altered gastro-duodenal luminal anatomy other than prior Billroth I reconstruction, as these would be anticipated to lead to more complicated procedures
  9. Coagulopathy or ongoing need for anti-coagulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421340


Contacts
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Contact: Elizabeth Kennedy 508-683-4807 Elizabeth.Kennedy@bsci.com
Contact: Srey Yin 508-683-4162 srey.yin@bsci.com

Locations
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United States, California
Stanford University Medical Center Not yet recruiting
Stanford, California, United States, 94305
Contact: Subhas Banerjee, MD       sbanerje@stanford.edu   
United States, Colorado
University of Colorado Hospital, Denver Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Raj J Shah, MD       Raj.Shah@ucdenver.edu   
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Janak Shah, MD       janak.shah@ochsner.org   
United States, Texas
Ertan Digestive Disease Center - University of Texas Health Science Center Recruiting
Houston, Texas, United States, 77030
Contact: Nirav Thosani, MD       Nirav.Thosani@uth.tmc.edu   
India
Asian Institute of Gastroenterology Recruiting
Hyderabad, Somajiguda, India, 500082
Contact: Mohan Ramchandani, MD       ramchandanimohan@gmail.com   
Italy
Fundazione Policlinico Universitario Agostino Gemelli Not yet recruiting
Rome, Italy, 00168
Contact: Guido Costamagna, MD       Guido.Costamagna@Unicatt.it   
Japan
Tokyo Medical University Not yet recruiting
Shinjuku-Ku, Tokyo, Japan, 160-0023
Contact: Takao Itoi, MD       itoi@tokyo-med.ac.jp   
Netherlands
Erasmus MC - University Medical Center of Rotterdam Not yet recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Marco Bruno, MD       m.bruno@erasmusmc.nl   
Thailand
King Chulalongkorn Memorial Hospital Recruiting
Pathum Wan, Bangkok, Thailand, 10330
Contact: Rungsun Rerknimitr, MD       ercp@live.com   
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Subhash Banerjee, MD Stanford University
Principal Investigator: Nirav Thosani, MD Univeristy of Texas Health Sciences
Principal Investigator: Raj J Shah, MD University of Colorado, Denver
Principal Investigator: Mohan Ramchandani, MD Asian Institure of Gastroenterology
Principal Investigator: Guido Costamagna, MD Fundazione Policlinico Universitario
Principal Investigator: Marco Bruno, MD Erasmus Medical Center
Principal Investigator: Rungsun Rerknimitr, MD King Chulalongkorn Memorial Hospital
Principal Investigator: Janak N Shah, MD Ochsner Health System
Principal Investigator: Takao Itoi, MD Tokyo Medical University

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03421340     History of Changes
Other Study ID Numbers: E7131
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Boston Scientific Corporation:
ERCP
DSC
Spy Glass
Biliary Stones
Choledocholithiasis
Non-Complex
Stones

Additional relevant MeSH terms:
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Calculi
Cholelithiasis
Cholecystolithiasis
Gallstones
Pathological Conditions, Anatomical
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases