An observational study in Gall Stones, sponsored by Northwell Health. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-19.
Sponsored by Northwell Health · Observational
Among 17 studies in Gallstones with a site in United States — none open to participants now, none under way, none of them phase 3. Gallstones · United States.
Among the 17 studies in Gallstones with a site in United States, this one is the only one that started in 2015, is one of 6 observational ones, and was the 13th registered.
200 studies on the registry are indexed under Gallstones; 36 are open to participants now.
Browse Gallstones studies →None of the 17 studies in Gallstones with a site in United States is open now. The open studies under Gallstones, anywhere →
Of the 24 Gallstones studies recruiting now, 11 (46%) set no upper age limit and 10 (42%) stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 140 is below the median of 200 across 71 observational studies indexed under Gallstones.
Median enrollment 25 across the 11 interventional studies, 130 across the 6 observational. Of the 11 that completed or were terminated, 1 (9%) have results posted.
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2 of 17 have an industry lead sponsor. The 10 most frequent:
Northwell Health is the lead sponsor of 475 studies on the registry; 107 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 23 (51%) have results posted.
Northwell Health has 1 study filed under Gallstones — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 17 studies in Gallstones with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Patients who are undergoing ERCP as their standard of care for treatment of their gall stones.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient receiving ERCP as standard of care for suspected or documented choledocholithiasis as assessed by one or more of the following:
In addition to one or more of the above inclusion criteria, patient must also satisfy one or more of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a cohort in which there are no stones seen on Cholangioscopy after ERCP and cholangiogram to treat gall stones.
This is a cohort in which there are no stones seen on Cholangioscopy after ERCP and cholangiogram to treat gall stones.
Missed stones found on Cholangioscopy
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.
Time frame: We will enroll approximately 100 patients over a 2-year period.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data will not be shared.
Ran from Dec 2015 to primary completion in Oct 2018, 34 months.
Of 23 observational studies under Gallstones, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 61. This study's 34 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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