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

Hui-Yun Zhu, Pei Xie, Ying-Xiao Song, Zhao-Shen Li, Zhen-Dong Jin, Yi-Qi Du, Hui-Yun Zhu, Pei Xie, Ying-Xiao Song, Zhao-Shen Li, Zhen-Dong Jin, Yi-Qi Du

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.

Keywords: DPPS; EUS; LAMS; Trial; WON.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval has been obtained from Changhai Institutional Review Board (CHEC2017–192). Written informed consent will be obtained from each patient before randomization. Any subsequent amendments of the protocol need to be approved by the relevant ethical bodies before implementation.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Research flow chart
Fig. 2
Fig. 2
Lumen-apposing metal stent (Micro-TechCo. Ltd., Nanjing, China)
Fig. 3
Fig. 3
Schedule of enrollment, follow-up, and assessments. Basline0: screening of laboratory tests can be accepted the previous week in our hospital inspection report. Stent removal1: time from stenting to postoperative withdrawal (33 ± 3 days). Blood routine2: hemoglobin (HGB), erythrocyte count (RBC), platelet count (PLT), leukocyte count (WBC), neutrophil percentage (%), lymphocyte percentage (%). Liver and kidney function3: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, direct bilirubin (DBIL), indirect bilirubin (IBIL), alkaline phosphatase (ALP), glutamyl transferase (GGT), blood urea nitrogen (BUN), creatinine (Cr). Coagulation function4: prothrombin time (PT), fibrinogen (FIB), activated partial thromboplastin time (APTT), thrombin time (TT). Serum amylase5: assessed 3 h and 24 h after the operation. CT6: preoperative and postoperative enhanced CT examination, 3 months and 6 months postoperative CT examination. The primary endpoint7: immediate success rate of surgery, drainage success rate 1 month after surgery. Secondary endpoints8: the incidence of clinical complications, operation time, the recurrence rate of pancreatic pseudocyst within 1 month and 1 month after the operation, and secondary interventions

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Source: PubMed

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