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Table 2 Definitions of the primary and secondary outcomes

From: Lumen-apposing metal stents (LAMS) versus plastic stents for EUS-guided drainage of walled-off necrosis (WON) (LVPWON): study protocol for a multicenter randomized controlled trial

Outcomes

Description

Clinical success

The diameter of the WON ≤ 2 cm

Technical success

LAMS or DPPS deployed successfully

Operation time

Time duration from the beginning to the end of the EUS-guided stent implantation procedure

Recurrence

After successful drainage, cyst reappears on imaging examinations with symptoms requiring intervention

Adverse event

 Perforation

Imaging manifests as pneumoperitoneum with peritoneal irritation syndrome

 Bleeding

Any bleeding that requires intervention, blood transfusion, and hospital observation

 Suprainfection

Postoperative fever, increased inflammatory index (CRP, PCT), or positive blood culture

 Occlusion

The stent is filled with tissue or debris

 Migration

The stent is completely or partially displaced into the WON or stomach

 Others

Adverse events that occurred in the trial but not described above

Secondary intervention

Any endoscopic operation after stent is placed

  1. CRP C-reactive protein, PCT procalcitonin