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Prospective Evaluation of Residual Bile Duct Stone by Peroral Cholangioscopy After Conventional ERCP

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ClinicalTrials.gov Identifier: NCT03482375
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Divyesh Sejpal, Northwell Health

Brief Summary:
Gallstone disease affects over 20 million Americans. Among patients with gallbladder disease, the prevalence of choledocholithiasis (stones in the bile duct) is estimated to be 10-20%. Endoscopic retrograde cholangiopancreatography (ERCP) is considered the standard of care for removing stones in the bile duct utilizing a variety of conventional methods including biliary sphincterotomy, sphincteroplasty, extraction balloon, retrieval basket, and mechanical lithotripsy. After removal of stones from the bile duct, an occlusion cholangiogram is usually performed to confirm complete bile duct clearance. However, cholangiogram can miss residual stones in 11- 30% of cases - especially in the setting of a dilated bile duct, large stones, severe pneumobilia, juxtapapillary diverticulum, primary sclerosing cholangitis, and after lithotripsy (mechanical, electrohydraulic, or laser). The approach to patients with choledocholithiasis requires careful attention because missed bile duct stones can cause recurrent biliary symptoms, pancreatitis, cholangitis, and has significant cost implication with the need for repeat imaging and/or procedures.

Condition or disease
Gall Stones

Detailed Description:

Peroral cholangioscopy (POC) provides direct visualization of the bile duct during ERCP and its benefits are well documented in numerous published studies. POC has been described for therapy of difficult to remove biliary stones utilizing electrohydraulic lithotripsy or laser lithotripsy with success rates of >90%. POC has also been used for evaluation of indeterminate filling defects and to assess for residual stones missed with cholangiogram. In a multicenter study evaluating POC for a variety of indications, 11% (7/66) of patients had bile duct stones identified only by POC that were missed on ERCP. In a study of patients with primary sclerosing cholangitis, 30% (7/23) of patients were found to have stones with POC that were missed with cholangiography. Takao et al. assessed residual bile duct stones found with POC in comparison to balloon-cholangiography; they found that 24% (26/108) of patients had residual stones seen with POC that were missed with balloon-cholangiography.

Although POC has been available for over thirty years, it has not become a widespread technique due to the fact that traditional cholangioscopes are fragile, cumbersome to use, and usually require two endoscopists to perform the procedure. A recent single operator semi-disposable cholangioscope, SpyGlass (Boston Scientific, Natick, Massachusetts), has addressed those concerns and has been shown in a studies to be a useful tool in visualizing the bile ducts and performing therapeutic maneuvers for biliary stones. Both ERCP and Cholangioscopy are standard of care procedures to treat gall stones.

The primary goal of the study is to assess if POC will enhance the diagnostic yield in the detection of residual biliary stones that are missed during conventional ERCP. Residual bile duct stones can especially be seen in the setting of bile duct dilation, history of recurrent abnormal liver function tests, and after lithotripsy (mechanical, electrohydraulic, or laser). Missed biliary stones can lead to recurrent biliary symptoms, pancreatitis, and cholangitis. POC after conventional ERCP can be a useful diagnostic tool to confirm complete extraction of bile duct stones, and thus lead to decreased morbidity and decreased cost by avoiding unnecessary tests and repeat procedures.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Prospective Evaluation of Residual Bile Duct Stone Detection by Peroral Cholangioscopy That Is Missed With Conventional ERCP and Cholangiogram
Actual Study Start Date : December 17, 2015
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : February 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

Group/Cohort
No Stones on POC after ERCP
This is a cohort in which there are no stones seen on Cholangioscopy after ERCP and cholangiogram to treat gall stones.
Stones seen on POC after ERCP
This is a cohort in which there are no stones seen on Cholangioscopy after ERCP and cholangiogram to treat gall stones.



Primary Outcome Measures :
  1. Missed stones found on Cholangioscopy [ Time Frame: We will enroll approximately 100 patients over a 2-year period. ]
    The primary outcome of this study is to assess if digital peroral cholangioscopy (POC) will enhance the diagnostic yield in the detection of residual biliary stones that are missed during conventional ERCP. The primary outcome will be assessed at the time of the procedure (i.e. residual stone seen with POC vs. no residual stone seen with POC). We will enroll approximately 100 patients over a 2-year period. At study completion, the primary outcome measure for all patients will be analyzed and data will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are undergoing ERCP as their standard of care for treatment of their gall stones.
Criteria

Inclusion Criteria:

  1. Patient receiving ERCP as standard of care for suspected or documented choledocholithiasis as assessed by one or more of the following:

    1. Abnormal imaging on ultrasound, endoscopic ultrasound (EUS), CT scan, or MRCP suggestive of choledocholithiasis
    2. Clinical signs and symptoms suggestive of choledocholithiasis such as jaundice, abdominal pain, pruritis, pancreatitis, and/or cholangitis
    3. Abnormal liver function tests suggestive of choledocholithiasis (eg: serum bilirubin > 1.5 and/or elevated alkaline phosphatase levels)
  2. In addition to one or more of the above inclusion criteria, patient must also satisfy one or more of the following:

    1. Mechanical lithotripsy, electrohydraulic lithotripsy, or laser lithotripsy performed for therapy of bile duct stones.
    2. Bile duct > 12mm on prior tests (any portion of duct)
    3. History of recurrent abnormal LFTs with negative cholangiogram.
    4. Positive EUS or MRCP for biliary stones with a negative cholangiogram

Exclusion Criteria:

  1. Patients less than 18 years of age.
  2. Patients not undergoing ERCP as their standard of care.
  3. Patients who had the following surgeries - Billroth II surgery, Roux-en-Y Gastric bypass surgery, and Whipple's surgery.

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): NCT03482375


Locations
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United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
LIJ Medical Center- NSLIJ Health System
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Northwell Health
Boston Scientific Corporation
Investigators
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Principal Investigator: Divyesh Sejpal, MD Northwell Health
  Study Documents (Full-Text)

Documents provided by Divyesh Sejpal, Northwell Health:

Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Divyesh Sejpal, Professor of Medicine, Chief of Endoscopy, Northwell Health
ClinicalTrials.gov Identifier: NCT03482375     History of Changes
Other Study ID Numbers: HS15-0674
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Divyesh Sejpal, Northwell Health:
Gall Stones
ERCP
Cholangioscopy

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