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Sphincterotomy for Biliary Sphincter of Oddi Disorder and Idiopathic Acute Recurrent Pancreatitis
TAKE-HOME MESSAGE
- In this multicenter prospective study, the impact of sphincterotomy was assessed in a cohort of patients (N = 213) with suspected sphincter of Oddi disorder. Overall, 57.4% of patients reported their symptoms as “much improved” or “very much improved” by the Patient Global Impression of Change scale without the need for reintervention or increased opioid requirement. Response by the Patient Global Impression of Change scale alone was 73.3% (118/161) in patients with complete follow-up data; however, 19 patients required reintervention and/or increased opioids. Bile duct dilation (diameter, ≥12 mm), elevated liver enzymes (more than twice the upper limit of normal), and prior history of acute pancreatitis were not associated with an increased likelihood of response to sphincterotomy. There were 37 patients (17.4%) who developed at least one episode of non-iatrogenic acute pancreatitis within the 12-month follow-up period, which was significantly more likely to occur in those with a prior history of acute pancreatitis (30.9% vs 2.9%; P < .0001).
- It is important to note that there was no control group in this study for comparison, and the impact of placebo response is unknown. Uncertainties remain regarding the optimal management of sphincter of Oddi disorder and identifying those who may respond to sphincterotomy.
abstract
This abstract is available on the publisher's site.
Access this abstract nowOBJECTIVE
Sphincter of Oddi disorders (SOD) are contentious conditions in patients whose abdominal pain, idiopathic acute pancreatitis (iAP) might arise from pressurisation at the sphincter of Oddi. The present study aimed to measure the benefit of sphincterotomy for suspected SOD.
DESIGN
Prospective cohort conducted at 14 US centres with 12 months follow-up. Patients undergoing first-time endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy for suspected SOD were eligible: pancreatobiliary-type pain with or without iAP. The primary outcome was defined as the composite of improvement by Patient Global Impression of Change (PGIC), no new or increased opioids and no repeat intervention. Missing data were addressed by hierarchal, multiple imputation scheme.
RESULTS
Of 316 screened, 213 were enrolled with 190 (89.2%) of these having a dilated bile duct, abnormal labs, iAP or some combination. By imputation, an average of 122/213 (57.4% (95% CI 50.4% to 64.4%)) improved; response rate was similar for those with complete follow-up (99/161, 61.5% (54.0% to 69.0%)); of these, 118 (73.3%) improved by PGIC alone. Duct size, elevated labs and patient characteristics were not associated with response. AP occurred in 37/213 (17.4%) at a median of 6 months post ERCP and was more likely in those with a history of AP (30.9% vs 2.9%, p<0.0001).
CONCLUSION
Nearly 60% of patients undergoing ERCP for suspected SOD improve, although the contribution of a placebo response is unknown. Contrary to prevailing belief, duct size and labs are poor response predictors. AP recurrence was common and like observations from prior non-intervention cohorts, suggesting no benefit of sphincterotomy in mitigating future AP episodes.
Additional Info
Disclosure statements are available on the authors' profiles:
Sphincterotomy for biliary sphincter of Oddi disorder and idiopathic acute recurrent pancreatitis: the RESPOnD longitudinal cohort
Gut 2024 Sep 07;[EPub Ahead of Print], GA Coté, BJ Elmunzer, H Nitchie, RS Kwon, F Willingham, S Wani, V Kushnir, A Chak, V Singh, GI Papachristou, A Slivka, M Freeman, S Gaddam, P Jamidar, P Tarnasky, S Varadarajulu, LD Foster, P CottonFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
This prospective multicenter cohort study (RESPOnD) tried to address if endoscopic sphincterotomy was beneficial in patients with sphincter of Oddi dysfunction (SOD). The study enrolled 213 patients who underwent endoscopic sphincterotomy for biliary SOD (type I [n = 19], type II [n = 54], and type III [n = 25]), pancreatic SOD (n = 59), or mixed biliary/pancreatic SOD (n = 55). Participants were followed for 1 year, with the primary outcome being a composite of i) Patient Global Impression of Change ("much improved" or "very much improved"), ii) fewer opioid prescriptions, and iii) no need for repeated endoscopic retrograde cholangiopancreatography (ERCP). The study results can be summarized in five key findings:
How do we put these findings together? First, the study provides helpful estimates to inform patients with SOD on what to expect from an ERCP. Although approximately 60% of patients did better after 1 year of the intervention, the study cannot answer whether this estimate was mechanistically related to the intervention or was owing to a placebo effect. Second, bedside evaluation for opioid use, somatization and physical/mental health may help endoscopists in stratifying patients who would respond or not to endoscopic sphincterotomy. Third, the study demystifies the old belief that patients with biliary SOD type I, II, and III would respond differently to ERCP, and challenges the utility of cross-sectional images and liver function tests for predicting treatment outcomes in these patients. Finally, the study suggests that endoscopic sphincterotomy does not significantly reduce the risk of recurrent pancreatitis in patients with idiopathic pancreatitis and raises concerns on continuing this long-standing practice. To move the field forward, we need better bedside diagnostic tests that accurately establishes the mechanisms of pain at the individual level and that allow us to more precisely guide treatment modalities rather than universally offering ERCPs to all patients with SOD.