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Original research
EUS versus MRCP to perform ERCP in patients with intermediate likelihood of choledocholithiasis: a randomised controlled trial
  1. Nitin Jagtap1,
  2. J Kiran Kumar1,
  3. Radhika Chavan1,
  4. Jahangeer Basha1,
  5. Manu Tandan1,
  6. Sundeep Lakhtakia1,
  7. Rakesh Kalapala1,
  8. Zaheer Nabi1,
  9. Rajesh Gupta1,
  10. Mohan Ramchandani1,
  11. Rupjyoti Talukdar1,
  12. Manohar Reddy1,
  13. Raghavendra Yarlagadda1,
  14. Jagadish Singh2,
  15. Sana Fatima Memon1,
  16. G Venkat Rao3,
  17. D Nageshwar Reddy1
  1. 1Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India
  2. 2Department of Radiodiagnosis and Interventional Radiology, Asian Institute of Gastroenterology, Hyderabad, India
  3. 3Department of Surgical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India
  1. Correspondence to Dr Nitin Jagtap, Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India; docnits13{at}gmail.com

Abstract

Objective In patients with an intermediate likelihood of choledocholithiasis, European Society of Gastrointestinal Endoscopy (ESGE) guidelines recommend endoscopic ultrasound (EUS) or magnetic resonance cholangiopancreatography (MRCP) to diagnose choledocholithiasis to make the indication for endoscopic retrograde cholangiopancreatography (ERCP) treatment; there is no randomised control trial to compare both in this setting.

Design Patients with suspected choledocholithiasis satisfying ESGE guideline’s intermediate likelihood were screened for this single-centre randomised controlled trial between November 2019 and May 2020. The enrolled patients were randomised to either EUS or MRCP. ERCP was performed in stone positive cases or if clinical suspicion persisted during follow-up. Negative cases underwent a further 6-month clinical follow-up. Main outcome was accuracy (sensitivity/specificity) of both tests to diagnose choledocholithiasis, with ERCP or follow-up as a gold standard.

Results Of 266 patients, 224 patients (mean age: 46.77±14.57 years; 50.9 % female) were enrolled; overall prevalence of choledocholithiasis was 49.6%, with a higher frequency in the MRCP group (63/112 vs 46/112 for EUS). Both sensitivity of EUS and MRCP were similarly high (92%–98%), without significant differences between the two groups. The negative predictive value and likelihood ratio + were significantly higher in EUS arm (p<0.05). The percentage of ERCPs either incorrectly halted back (false negatives: EUS: 2 vs MRCP: 5) or performed unnecessarily (false positives: EUS: 1 vs MRCP: 2) was low in both groups.

Conclusion The performance parameters of both EUS and MRCP are comparable for detecting choledocholithiasis in the intermediate-risk group of choledocholithiasis and the choice of a test should be based on local expertise, availability of resources and patient preference.

Trial registration number NCT04173624.

  • endoscopic ultrasonography
  • Magnetic Resonance Imaging
  • gallstones
  • diagnostic and therapeutic endoscopy
  • gallstone disease

Data availability statement

Data are available upon reasonable request. We would make data available upon reasonable request for academic purpose.

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Data availability statement

Data are available upon reasonable request. We would make data available upon reasonable request for academic purpose.

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Footnotes

  • Twitter @drkalpala

  • Contributors Concept: NJ and JKK. Design: NJ, RC, JB and SL. Supervision: RG, RK, MT and MRamchandani. Resources: NJ, ZN, RY and MReddy. Data collection and/or processing: NJ, JKK and SFM. Analysis and interpretation: NJ, RT and MT. Literature search: JKK and NJ. Writing the manuscript: NJ, MT and SL. Critical review: GVR and DNR. Final approval: all authors. NJ is the guarantor.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.