2024 Top Story in Gastroenterology: Prophylactic Stent Placement for Post-ERCP Pancreatitis

There are many candidates for the 2024 Top Story for endoscopy from the featured articles in PracticeUpdate Gastroenterology. This year, I believe the Top Story is the initial report from the stent versus indomethacin trial published in The Lancet titled "Indomethacin With or Without Prophylactic Pancreatic Stent Placement to Prevent Pancreatitis After ERCP: A Randomised Non-Inferiority Trial" by Elmunzer et al.¹ This is a critically important work in gastrointestinal endoscopy not only because it addresses an essential clinical issue (do we need to place pancreatic duct stents to reduce post-ERCP pancreatitis rates?) but also because it represents one of the few NIH-sponsored clinical research trials in endoscopy. Taking more than a decade from its inception to completion, this trial randomized 1950 patients undergoing ERCP, who were characterized as high-risk, to either indomethacin suppositories alone or indomethacin suppositories plus a pancreatic stent. The study was completed with the cooperation of multiple expert centers, and the results have shaped and will continue to shape the practice of gastroenterology.

Pancreatitis remains a feared complication of ERCP, with established patient injuries, increased medical costs, and even deaths. This study included high-volume academic and tertiary referral centers and excluded patients who were undergoing ERCP with a low risk of post-ERCP pancreatitis (PEP). All of the enrolled patients received indomethacin suppositories. Patients were randomized to receive a protective pancreatic stent (size and length determined by the procedure physician) versus no additional therapy. In the intention-to-treat analysis, 11.3% of the high-risk participants who underwent ERCP and received pancreatic duct stenting in addition to indomethacin developed PEP, whereas 14.9% in the indomethacin-only group developed PEP. More importantly, the severity of PEP was higher and there were three deaths reported in the indomethacin-alone group versus no deaths in the stent group. Not only was this difference significant but it is likely even more so as 20% of the patients randomized to a pancreatic duct stent did not have a stent placed for various reasons. The study offers important take-home messages for all physicians who perform ERCP.

1. Pancreatic duct stent placement in addition to rectal indomethacin should be performed in all high-risk patients. In this study, high-risk patients were defined as those with a history of PEP, difficult cannulation (defined as six or more cannulation attempts or ≥6-minute duration of cannulation), precut sphincterotomy (a procedure to facilitate biliary access when standard cannulation techniques are unsuccessful), pancreatic sphincterotomy, short-duration (≤1 minute) balloon dilation of an intact biliary sphincter, or clinical suspicion of sphincter of Oddi dysfunction.

2. All physicians who perform ERCP should be capable of placing a pancreatic duct stent in any patient who is high-risk or becomes high-risk during an ERCP (see the first point, above)

3. Even with indomethacin and pancreatic duct stenting, the incidence of PEP in high-risk patients is greater than 11%.

4. Further studies to define the role of supplemental treatments such as standardized IV hydration and specific types of pancreatic stents to further reduce PEP should be designed and completed.

This study also demonstrates the cost, complexity, and time needed to answer important questions in our field with randomized controlled studies. This work would not have been possible without the dedication of clinician scientists in the US and Canada. Also, without the support of the NIH, studies of this type could not be performed. This study will have immediate clinical implications that will hopefully reduce injury and even deaths in our patients undergoing ERCP. Hopefully, dedicated investigators in our field can continue to persuade the NIH to fund these important clinical trials.