Endoscopic ultrasound-guided transluminal drainage using lumen-apposing metal stent with or without coaxial plastic stent for treatment of walled-off necrotizing pancreatitis: a prospective bicentric randomized controlled trial
Abstract
BACKGROUND AND AIMS
Lumen-apposing metal stents (LAMS) have proven to be effective for drainage of pancreatic walled-off necrosis (WON), although associated adverse events (AE) have been reported. Anchoring coaxial double-pigtail plastic stents (DPS) within LAMS have been proposed to prevent LAMS-related AEs, but have not been assessed in prospective studies. We aimed to evaluate the utility of such measures with a randomized controlled trial.
METHODS
We randomly assigned consecutive patients with WON indications for drainage to endoscopic ultrasound (EUS)-guided transluminal drainage using LAMS with (A) or without (B) DPS. All LAMS were to be extracted after 3 weeks had elapsed from the index procedure with a preceding CT scan to decide whether additional steps needed to be taken, e.g., transluminal necrosectomy, or placing transluminal plastic stents in patients with incomplete resolution of WON. Main outcomes included failure of the index method, defined as necessity of re-intervention (endoscopic, percutaneous, surgical) before LAMS extraction due to LAMS-related AEs and/or clinical deterioration, AE rates, and mortality with LAMS in place. Variables were evaluated using the Mann-Whitney U test, χ2 test or Fisher's exact test as appropriate. P < .05 was considered significant.
RESULTS
A total of 67 patients (37.3% females, mean age 54 ± 14.4 years) underwent LAMS with (n = 34) or without DPS (n = 33) placement in two tertiary centers. Baseline characteristics including…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 67 participants or records.
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