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

NCT03482375 | Completed

• 1 other identifier: HS15-0674
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Gall Stones

Keywords

Gall Stones; ERCP; Cholangioscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  We will enroll approximately 100 patients over a 2-year period.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are undergoing ERCP as their standard of care for treatment of their gall stones.

You may qualify if:

• Patient receiving ERCP as standard of care for suspected or documented choledocholithiasis as assessed by one or more of the following:
• Abnormal imaging on ultrasound, endoscopic ultrasound (EUS), CT scan, or MRCP suggestive of choledocholithiasis
• Clinical signs and symptoms suggestive of choledocholithiasis such as jaundice, abdominal pain, pruritis, pancreatitis, and/or cholangitis
• Abnormal liver function tests suggestive of choledocholithiasis (eg: serum bilirubin \> 1.5 and/or elevated alkaline phosphatase levels)
• Mechanical lithotripsy, electrohydraulic lithotripsy, or laser lithotripsy performed for therapy of bile duct stones.
• Bile duct \> 12mm on prior tests (any portion of duct)
• History of recurrent abnormal LFTs with negative cholangiogram.
• Positive EUS or MRCP for biliary stones with a negative cholangiogram

You may not qualify if:

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

Sponsors & Collaborators

• Northwell Health: lead
• Boston Scientific Corporation: collaborator

Study Sites (2)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

LIJ Medical Center- NSLIJ Health System

New Hyde Park, New York, 11040, United States

Location

Related Publications (12)

• Everhart JE, Khare M, Hill M, Maurer KR. Prevalence and ethnic differences in gallbladder disease in the United States. Gastroenterology. 1999 Sep;117(3):632-9. doi: 10.1016/s0016-5085(99)70456-7.

  PMID: 10464139 BACKGROUND

• Neuhaus H, Feussner H, Ungeheuer A, Hoffmann W, Siewert JR, Classen M. Prospective evaluation of the use of endoscopic retrograde cholangiography prior to laparoscopic cholecystectomy. Endoscopy. 1992 Nov;24(9):745-9. doi: 10.1055/s-2007-1010576.

  PMID: 1468389 BACKGROUND

• Lacaine F, Corlette MB, Bismuth H. Preoperative evaluation of the risk of common bile duct stones. Arch Surg. 1980 Sep;115(9):1114-6. doi: 10.1001/archsurg.1980.01380090080019.

  PMID: 7416958 BACKGROUND

• Chen YK, Parsi MA, Binmoeller KF, Hawes RH, Pleskow DK, Slivka A, Haluszka O, Petersen BT, Sherman S, Deviere J, Meisner S, Stevens PD, Costamagna G, Ponchon T, Peetermans JA, Neuhaus H. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc. 2011 Oct;74(4):805-14. doi: 10.1016/j.gie.2011.04.016. Epub 2011 Jul 18.

  PMID: 21762903 BACKGROUND

• Awadallah NS, Chen YK, Piraka C, Antillon MR, Shah RJ. Is there a role for cholangioscopy in patients with primary sclerosing cholangitis? Am J Gastroenterol. 2006 Feb;101(2):284-91. doi: 10.1111/j.1572-0241.2006.00383.x.

  PMID: 16454832 BACKGROUND

• Itoi T, Sofuni A, Itokawa F, Shinohara Y, Moriyasu F, Tsuchida A. Evaluation of residual bile duct stones by peroral cholangioscopy in comparison with balloon-cholangiography. Dig Endosc. 2010 Jul;22 Suppl 1:S85-9. doi: 10.1111/j.1443-1661.2010.00954.x.

  PMID: 20590779 BACKGROUND

• ASGE Standards of Practice Committee; Maple JT, Ben-Menachem T, Anderson MA, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Strohmeyer L, Dominitz JA. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010 Jan;71(1):1-9. doi: 10.1016/j.gie.2009.09.041. No abstract available.

  PMID: 20105473 BACKGROUND

• Piraka C, Shah RJ, Awadallah NS, Langer DA, Chen YK. Transpapillary cholangioscopy-directed lithotripsy in patients with difficult bile duct stones. Clin Gastroenterol Hepatol. 2007 Nov;5(11):1333-8. doi: 10.1016/j.cgh.2007.05.021. Epub 2007 Jul 23.

  PMID: 17644045 BACKGROUND

• Arya N, Nelles SE, Haber GB, Kim YI, Kortan PK. Electrohydraulic lithotripsy in 111 patients: a safe and effective therapy for difficult bile duct stones. Am J Gastroenterol. 2004 Dec;99(12):2330-4. doi: 10.1111/j.1572-0241.2004.40251.x.

  PMID: 15571578 BACKGROUND

• Farrell JJ, Bounds BC, Al-Shalabi S, Jacobson BC, Brugge WR, Schapiro RH, Kelsey PB. Single-operator duodenoscope-assisted cholangioscopy is an effective alternative in the management of choledocholithiasis not removed by conventional methods, including mechanical lithotripsy. Endoscopy. 2005 Jun;37(6):542-7. doi: 10.1055/s-2005-861306.

  PMID: 15933927 BACKGROUND

• Chen YK, Pleskow DK. SpyGlass single-operator peroral cholangiopancreatoscopy system for the diagnosis and therapy of bile-duct disorders: a clinical feasibility study (with video). Gastrointest Endosc. 2007 May;65(6):832-41. doi: 10.1016/j.gie.2007.01.025.

  PMID: 17466202 BACKGROUND

• Sejpal DV, Trindade AJ, Lee C, Miller LS, Benias PC, Inamdar S, Singh G, Stewart M, George BJ, Vegesna AK. Digital cholangioscopy can detect residual biliary stones missed by occlusion cholangiogram in ERCP: a prospective tandem study. Endosc Int Open. 2019 Apr;7(4):E608-E614. doi: 10.1055/a-0842-6450. Epub 2019 Apr 12.

  PMID: 30993165 DERIVED

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Divyesh Sejpal, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Chief of Endoscopy

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 29, 2018
• Study Start: December 17, 2015
• Primary Completion: October 30, 2018
• Study Completion: February 10, 2019
• Last Updated: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)