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

Zhu, Huiyun; Xie, Pei; Song, Ying-Xiao; Li, Zhao‐Shen; Jin, Zhendong; Du, Yiqi

doi:10.1186/s13063-018-2901-3

Cited by 11 publications

(9 citation statements)

References 23 publications

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“…In conclusion, we confirm the results of a recent systematic review of mainly retrospective studies, reporting that there is no increased bleeding risk when using LAMS 22. The results of two ongoing randomised trials will provide more information on LAMS safety 23 24…”

Section: Discussionsupporting

confidence: 87%

Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis

Boxhoorn

Verdonk

Besselink

et al. 2022

Gut

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ObjectiveLumen-apposing metal stents (LAMS) are believed to clinically improve endoscopic transluminal drainage of infected necrosis when compared with double-pigtail plastic stents. However, comparative data from prospective studies are very limited.DesignPatients with infected necrotising pancreatitis, who underwent an endoscopic step-up approach with LAMS within a multicentre prospective cohort study were compared with the data of 51 patients in the randomised TENSION trial who had been assigned to the endoscopic step-up approach with double-pigtail plastic stents. The clinical study protocol was otherwise identical for both groups. Primary end point was the need for endoscopic transluminal necrosectomy. Secondary end points included mortality, major complications, hospital stay and healthcare costs.ResultsA total of 53 patients were treated with LAMS in 16 hospitals during 27 months. The need for endoscopic transluminal necrosectomy was 64% (n=34) and was not different from the previous trial using plastic stents (53%, n=27)), also after correction for baseline characteristics (OR 1.21 (95% CI 0.45 to 3.23)). Secondary end points did not differ between groups either, which also included bleeding requiring intervention—5 patients (9%) after LAMS placement vs 11 patients (22%) after placement of plastic stents (relative risk 0.44; 95% CI 0.16 to 1.17). Total healthcare costs were also comparable (mean difference −€6348, bias-corrected and accelerated 95% CI −€26 386 to €10 121).ConclusionOur comparison of two patient groups from two multicentre prospective studies with a similar design suggests that LAMS do not reduce the need for endoscopic transluminal necrosectomy when compared with double-pigtail plastic stents in patients with infected necrotising pancreatitis. Also, the rate of bleeding complications was comparable.

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Section: Discussionsupporting

confidence: 87%

Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis

Boxhoorn

Verdonk

Besselink

et al. 2022

Gut

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“…Bang et al [ 13 ] reported that the procedural cost of LAMS and plastic stent was US $12155 and US $6609, respectively. There are few data on the cost of LAMS in China, but a multicenter randomized controlled trial (LVPWON trial) has been designed to determine whether LAMS is effective, safe and superior to plastic stenting for WON drainage[ 25 ]. We realize that it is inappropriate to compare the cost of EGF and LAMS only based on this study; thus, we intend to conduct a prospective study to compare EGF with endoscopic LAMS/plastic stent drainage in the future, which could provide more convincing evidence.…”

Section: Discussionmentioning

confidence: 99%

Endoscopic gastric fenestration of debriding pancreatic walled-off necrosis: A pilot study

Liu¹,

Wang

et al. 2020

WJG

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BACKGROUND Endoscopic drainage of walled-off necrosis (WON) is still a challenge due to stent-associated problems. We explored endoscopic gastric fenestration (EGF) as an innovative alternative intervention. AIM To assess the feasibility, efficacy and safety of EGF for WON. METHODS Between March 2019 and March 2020, five patients with symptomatic WON in close contact with the stomach wall were treated by EGF. Endoscopic ultrasound (EUS) was used to select appropriate sites for gastric fenestration, which then proceeded layer by layer as in endoscopic submucosal dissection. Both the stomach muscularis propria and pseudocyst capsule were penetrated. Fenestrations were expanded up to 1.5-3 cm for drainage or subsequent necrosectomy. RESULTS EGF failed in Case 1 due to nonadherence of WON to the gastric wall. EGF was successfully implemented in the other four cases by further refinement of fenestration site selection according to computed tomography, endoscopy and EUS features. The average procedure time for EGF was 124 min (EUS assessment, 32.3 min; initial fenestration, 28.8 min; expanded fenestration, 33 min), and tended to decrease as experience gradually increased. The diameter of the fenestration site was 1.5-3 cm, beyond the caliber of a lumen-apposing metal stent (LAMS), to ensure effective drainage or subsequent necrosectomy. Fenestration sites showed surprising capacity for postoperative self-healing within 1-3 wk. No EGF-related complications were seen. WON disappeared within 3 wk after EGF. In Case 3, another separate WON, treated by endoscopic LAMS drainage, recurred within 4 d after LAMS removal due to stent-related hemorrhage, and resolved slowly over almost 3 mo. No recurrences were observed in the five patients. CONCLUSION EGF is an innovative and promising alternative intervention for WON adherent to the gastric wall. The challenge resides in the gauging of actual adherence and in selecting appropriate fenestration sites.

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“…DPPSs (7F, 7 cm, Cook Medical) or LAMSs (diameter: 16 mm; length: 20/30 mm, Micro‐TechCo. Ltd, Nanjing, China) 5 were placed over the guidewire for WON drainage. The type and number of stents used for drainage were at the discretion of endoscopists.…”

Section: Methodsmentioning

confidence: 99%

The role of solid debris in endoscopic ultrasound‐guided drainage of walled‐off necrosis: A large cohort study

Zhu

Xie

Wang

et al. 2020

J of Gastro and Hepatol

Self Cite

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Background and Aim: The effect of solid debris on walled-off necrosis (WON) drainage remains unknown. Our study evaluated the role of solid debris in endoscopic ultrasound (EUS)-guided drainage of WON compared lumen-apposing metal stent (LAMS) with double-pigtail plastic stent (DPPS). Methods: We retrospectively evaluated consecutive patients with WON who underwent EUS-guided drainage in our endoscopic center over a 9-year period. The amount of solid debris in WON was assessed with computed tomography or magnetic resonance imaging and EUS images. Results: From 2011 to 2019, 84 WON patients were included. In WON with < 20% solid debris, the short-term clinical success of LAMSs (96.8%) was significantly higher than DPPSs (66.7%) (P = 0.03), and LAMSs were safer than DPPSs with less early adverse events (P = 0.02) and late adverse events (P = 0.03). On multivariable analysis, DPPS (odds ratio [OR], 0.16; 95% confidence interval [CI], 0.04-0.65; P = 0.01) and solid debris > 40% (OR, 0.11; 95% CI, 0.02-0.62; P = 0.01) were the predictors for failure of resolution of WON after adjusting for age and cyst size. The number of DPPSs used was significantly higher than LAMSs in managing WONs (P < 0.001). Conclusion: For WON with < 20% solid debris, LAMSs might superior to DPPSs in terms of efficacy and safety.

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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

Cited by 11 publications

References 23 publications

Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis

Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis

Endoscopic gastric fenestration of debriding pancreatic walled-off necrosis: A pilot study

The role of solid debris in endoscopic ultrasound‐guided drainage of walled‐off necrosis: A large cohort study

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