Endoscopy 2024; 56(12): 915-923
DOI: 10.1055/a-2332-3448
Original article

Biflanged metal stents versus plastic stents for endoscopic ultrasound-guided drainage of walled-off necrosis: a randomized controlled trial

Krithi Krishna Koduri
1   Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
,
1   Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
,
1   Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
,
1   Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
,
1   Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
,
Rupjyoti Talukdar
1   Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
,
Guru Trikudanathan
2   Gastroenterology, Hepatology and Nutrition, University of Minnesota Twin Cities, Minneapolis, United States (Ringgold ID: RIN5635)
,
Manu Tandan
1   Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
,
Rakesh Kalapala
1   Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
,
1   Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
,
Rajesh Gupta
1   Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
,
Mohan Ramchandani
1   Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
,
Jagadish Singh
3   Radiodiagnosis and Interventional Radiology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
,
Sana Fatima Memon
1   Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
,
G. Venkat Rao
4   Surgical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
,
D. Nageshwar Reddy
1   Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)
› Author Affiliations
Clinical Trial: Registration number (trial ID): NCT04479228, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Randomized


Abstract

Background Endoscopic ultrasound (EUS)-guided drainage of walled-off necrosis (WON) using either plastic or metal stents is the mainstay of WON management. Our single-center randomized controlled trial aimed to evaluate the efficacy of biflanged metal stents (BFMSs) and plastic stents for WON drainage.

Methods Patients with symptomatic WON amenable to EUS-guided drainage were randomized to receive either BFMSs or plastic stents. The primary outcome was reintervention-free clinical success at 4 weeks. Secondary outcomes were: overall clinical success (complete resolution of symptoms and significant reduction in size of WON [<50% of original size and <5 cm in largest diameter at 4-week follow-up]); number of reinterventions; adverse events (AEs); hospital stay for first admission; and medium-term outcomes at 6 months (recurrence, disconnected pancreatic duct, chronic pancreatitis, and new-onset diabetes mellitus).

Results 92 patients were randomized: 46 in each arm. The reintervention-free clinical success rate was significantly higher in the BFMS group on intention-to-treat analysis (67.4% vs. 43.5%; P = 0.02). Overall clinical success at 1 month was similar in both groups. There were significantly fewer reinterventions (median 0 [IQR 0–1] vs. 1 [0–2]; P = 0.03) and shorter hospital stays in the BFMS group (7.0 [SD 3.4] vs. 9.1 [5.5] days; P = 0.04). There were no differences in procedure-related AEs, mortality, or medium-term outcomes.

Conclusions BFMSs provide better reintervention-free clinical success at 4 weeks, with shorter hospital stay and without increased risks of AEs, compared with plastic stents for EUS-guided drainage of WON. Medium-term outcomes are however similar for both stent types.

Supplementary Material



Publication History

Received: 16 August 2023

Accepted after revision: 23 May 2024

Accepted Manuscript online:
23 May 2024

Article published online:
30 July 2024

© 2024. Thieme. All rights reserved.

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

 
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