Endoscopic retrograde biliary drainage plus glucocorticoids versus glucocorticoid alone for autoimmune pancreatitis with significant obstructive jaundice: study protocol for a multicenter, open-label, non-inferiority randomized controlled trial.

BACKGROUND

Patients with autoimmune pancreatitis (AIP) frequently develop obstructive jaundice. Endoscopic retrograde biliary drainage (ERBD) is typically performed before glucocorticoid initiation to prevent biliary infections and worsening cholestasis. While guidelines support glucocorticoid monotherapy without ERBD for mild jaundice, its efficacy and safety remain unestablished in AIP patients with clinically significant obstructive jaundice. This trial aims to determine whether glucocorticoid monotherapy is noninferior to ERBD plus glucocorticoids as initial therapy for AIP patients with significant obstructive jaundice.

METHODS/

DESIGN

In this multicenter, noninferiority, open-label, randomized controlled trial, 78 patients with significant obstructive jaundice without concurrent cholangitis (serum total bilirubin ≥ 3 × ULN) across 13 centers in China will be randomly assigned to receive either ERBD plus glucocorticoids or glucocorticoids alone (39 patients per group). The primary endpoint is the clinical response rate, which was defined as a ≥ 50% reduction in the total bilirubin level within 2 weeks of the intervention. The secondary outcomes are adverse event rates, including ERCP-related complications and glucocorticoid-related adverse events.

DISCUSSION: This trial is expected to reveal whether ERBD is routinely required before glucocorticoid administration in AIP patients with significant obstructive jaundice, which is an important question that has not been addressed via an RCT design. The results will supplement the evidence for clinical decision-making and may provide a more straightforward basis for treatment selection, potentially simplifying the management of these patients.

TRIAL REGISTRATION: Chictr.org.cn ChiCTR2400086160. Registered on June 26, 2024.