Abstract
Background
Endoscopic ultrasonography (EUS)-guided drainage has become the first-line therapy for late peri-pancreatic fluid collection (PFC). Double pigtail plastic stents (DPPS) and lumen-apposing metal stents (LAMS) are commonly used for PFC drainage. Recently, a multi-institutional consensus on PFC drainage has recommended that LAMS should be the standard care for patients with walled-off necrosis (WON). However, given the poor quality of evidence, we aim to perform a large-scale randomized controlled trial to determine whether LAMS is superior to DPPS for WON drainage.
Methods/design
The study is an open-label, prospective, parallel-group, superiority, multicenter randomized controlled trial. Two hundred and fifty-six patients with WON who will attend 18 tertiary hospitals in China will be randomly allocated to the LAMS or DPPS group before the procedure. The primary endpoint is the clinical success at one month after drainage (reduction in the size of WON to < 2 cm). Secondary endpoints include technical success, operation time, recurrence, adverse events, and secondary interventions.
Discussion
The LVPWON trial is designed to determine whether LAMS is effective, safe, and superior to DPPS for WON drainage.
Trial registration
ClinicalTrials.gov, NCT03027895. Registered on 14 January 2017.
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Details
1 Second Military Medical University/ Naval Medical University, Department of Gastroenterology, Changhai Hospital, Shanghai, China (GRID:grid.73113.37) (ISNI:0000 0004 0369 1660)
2 Second Military Medical University/ Naval Medical University, Department of Gastroenterology, Changhai Hospital, Shanghai, China (GRID:grid.73113.37) (ISNI:0000 0004 0369 1660); Second Military Medical University/ Naval Medical University, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China (GRID:grid.73113.37) (ISNI:0000 0004 0369 1660)
3 Second Military Medical University/ Naval Medical University, Department of Gastroenterology, Changhai Hospital, Shanghai, China (GRID:grid.73113.37) (ISNI:0000 0004 0369 1660); Second Military Medical University/ Naval Medical University, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China (GRID:grid.73113.37) (ISNI:0000 0004 0369 1660); Shanghai Institute of Pancreatic Diseases, Shanghai, China (GRID:grid.73113.37); National Clinical Research Center of Digestive Diseases, Shanghai, China (GRID:grid.73113.37)