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Letter
SPHINX, a Guardian of Wisdom
  1. Anke Onnekink1,
  2. Roy L J van Wanrooij2,
  3. Jeanin E Van Hooft1
  1. 1 Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands
  2. 2 Gastroenterology and Hepatology, Amsterdam UMC Locatie VUmc, Amsterdam, Noord-Holland, The Netherlands
  1. Correspondence to Dr Anke Onnekink; a.m.onnekink{at}lumc.nl

https://doi.org/10.1136/gutjnl-2024-334569

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    We thank Ramchandani et al for their letter on the SPHINX trial and appreciate the opportunity to address their points.1 2

    Sample size

    The SPHINX trial aimed to assess whether endoscopic sphincterotomy (ES) could reduce post-ERCP pancreatitis (PEP). However, quantifying this effect proved difficult due to conflicting results from previous, heterogeneous randomised controlled trials (RCTs), which differed in sample size, patient populations and stent types.3–5 The trial by Zhou et al (2012) reported a 69% relative risk reduction in PEP after ES, which served as reference for our sample size calculation.3 However, since the other trials did not show this benefit, we considered this effect overestimated.4 5 The SPHINX trial was designed to detect a 50% relative risk reduction in PEP in patients with suspected distal malignant biliary obstruction (MBO). Based on data from a Dutch prospective …

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    Footnotes

    • Contributors AO: conceptualisation, writing - original. RLJvW and JEV-H: writing - review and editing.

    • 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 JvH has received research support from Cook Medical and acted as lecturer for Cook Medical, Boston Scientific, and Falk and as consultant for Olympus, outside the submitted work. RvW acted as a consultant for Boston Scientific, outside the submitted work.

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