Among patients with predicted severe acute biliary pancreatitis (PSABP) without cholangitis, urgent endoscopic ultrasonography (EUS)-guided endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (ES) is not associated with a decrease in major complications or mortality compared with conservative treatment, according to a study in Gut.
The prospective Acute biliary Pancreatitis: urgent ERCP with sphincterotomy vs conservative treatment (APEC-2) study sought to determine whether a strategy with urgent EUS followed by urgent ERCP with ES for common bile duct (CBD) stones/sludge would reduce major complications or mortality in patients with PSABP.
The multicenter study compared outcomes with those of the conservative treatment group from the recent APEC trial.
EUS was required to be performed within 72 hours after symptom onset and within 24 hours after presentation at the emergency department. ERCP with ES was conducted subsequently if gallstones and sludge in the CBD were observed during EUS.
The primary endpoint was a composite of major complications or mortality occurring within 6 months after inclusion.
A total of 83 patients were included in the Urgent EUS ± ERCP with ES group (mean [SD] age, 70 years; women, 45%), of whom 81 patients (98%) underwent EUS. The conservative treatment group included 113 participants (mean age, 71 years; women, 47%).
The primary composite endpoint of major complications or mortality was observed in 34 patients (41%) in the urgent EUS group vs 50 patients (44%) in the conservative treatment group (risk ratio [RR], 0.93; 95% CI, 0.67-1.29; P =.65).
In the urgent EUS group, 5 patients (6%) died compared with 10 patients (9%) in the conservative group (RR, 0.68; 95% CI, 0.24-1.91; P =.46).
In logistic regression analysis, no significant relationship was found among sex, American Society of Anesthesiologists’ grade, or organ failure at baseline and the effect of urgent EUS-guided ERCP regarding the primary endpoint (adjusted odds ratio, 1.03; 95% CI, 0.56-1.90; P =.92).
Adverse events were observed in 63 patients (76%) in the EUS group and in 90 patients (80%) in the conservative treatment group (RR, 0.95; 95% CI, 0.82-1.11; P =.53).
A total of 81 patients (98%) in the urgent EUS group had EUS at a median of 29 hours (IQR, 23-42) after symptom onset and 21 hours (IQR, 17-23) after emergency department presentation. A positive EUS was observed in 48 patients (58%), all of whom had immediate ERCP. The median time from EUS to ERCP was 10 minutes (IQR, 5-33). Among participants with a positive EUS, 14 of 48 patients (29%) had only sludge/microlithiasis in the bile ducts and 34 (71%) had at least 1 stone.
Among urgent EUS patients, 53 (64%) had ERCP with ES, and performance of ERCP was based on urgent EUS findings in 48 patients. The initial EUS investigation at admission was negative for 5 patients (6%), although they subsequently had ERCP. Progressive cholestasis was observed in 3 patients, and CBD stones were removed during ERCP.
For the conservative group, an ERCP was conducted in 35 of 113 (31%) patients at a median of 8 days (IQR, 3-34) after inclusion, with sphincterotomy occurring in 30 of those patients (86%). Persistent cholestasis was the indication for ERCP in 21 patients (19%) and cholangitis in 13 patients (12%). Stones were extracted in 25 patients (71%).
Study limitations include use of a prospective cohort series and the potential for bias. Also, the groups had some differences in baseline characteristics, including fewer patients with organ failure at baseline in the urgent EUS-guided ERCP group.
“We recommend a conservative treatment strategy in patients with a PSABP, with an ERCP only in case of concomitant cholangitis (urgent indication) and symptomatic and/or persistent choledocholithiasis (elective indication),” the researchers noted.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Hallensleben ND, Stassen PMC, Schepers NJ, et al. Patient selection for urgent endoscopic retrograde cholangio-pancreatography by endoscopic ultrasound in predicted severe acute biliary pancreatitis (APEC-2): a multicentre prospective study. Gut. Published online February 27, 2023. doi:10.1136/gutjnl-2022-328258