Clinical Trials

OVERVIEW

The Division of Gastroenterology and Hepatology conducts clinical trials on novel therapeutics for various liver diseases, bringing promising and innovative therapies to our patients.

Our team has extensive experience selecting the right patients for the right trials.

Clinical trials are an important part of the research involved in developing new medical treatments. Enrolling in a clinical trial enables participants to take an active role in their own health care, gain entrance to new research, and contribute to medical science.

Participants must meet specific criteria to be eligible for enrollment in a clinical trial. Some research studies seek participants with illnesses or specific conditions to be studied in the clinicaltrial, while others ask for healthy participants.

CURRENT AND ONGOING TRIALS

Non-Complex Biliary Stones DSC vs ERC

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).

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • device: DSC
  • device: ERC

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Tanvi Chitre
650-723-9651
I'm interested