ArticleTrials2023
WONDER-01: immediate necrosectomy vs. drainage-oriented step-up approach after endoscopic ultrasound-guided drainage of walled-off necrosis-study protocol for a multicentre randomised controlled trial.
Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05451901 (Immediate Necrosectomy vs. Step-up Approach After EUS-guided Drainage of Walled-off Necrosis), which is not on this map. Cited by 7 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Immediate Necrosectomy vs. Step-up Approach After EUS-guided Drainage of Walled-off Necrosis: a Multicenter Randomized Controlled Trial (WONDER-01)
Who cites it
7 citing papers in PubMed, 18 citations in OpenAlex.
- The Multidisciplinary Approach to Acute Necrotizing Pancreatitis.Journal of clinical medicine · 2025Review
- Comorbidity burden and outcomes of endoscopic ultrasound-guided treatment of pancreatic fluid collections: Multicenter study with nationwide data-based validation.Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society · 2025Article
- Drainage for fluid collections post pancreatic surgery and acute pancreatitis: similar but different?Clinical endoscopy · 2024Review
- Artificial intelligence-based skeletal muscle estimates and outcomes of EUS-guided treatment of pancreatic fluid collections.iGIE : innovation, investigation and insights · 2024Article
- Article
- Step-up approach for the treatment of infected necrotising pancreatitis: real life data from a single-centre experience with long-term follow-up.BMC gastroenterology · 2024Observational
- Indications, Techniques and Future Perspectives of Walled-off Necrosis Management.Diagnostics (Basel, Switzerland) · 2024Review
Corrections and comments
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Authors and funding
29 authors at 20 institutions in 1 country.
Funding
Abstract
backgroundWith the increasing popularity of endoscopic ultrasound (EUS)-guided transmural interventions, walled-off necrosis (WON) of the pancreas is increasingly managed via non-surgical endoscopic interventions. However, there has been an ongoing debate over the appropriate treatment strategy following the initial EUS-guided drainage. Direct endoscopic necrosectomy (DEN) removes intracavity necrotic tissue, potentially facilitating early resolution of the WON, but may associate with a high rate of adverse events. Given the increasing safety of DEN, we hypothesised that immediate DEN following EUS-guided drainage of WON might shorten the time to WON resolution compared to the drainage-oriented step-up approach.
methodsThe WONDER-01 trial is a multicentre, open-label, superiority, randomised controlled trial, which will enrol WON patients aged ≥ 18 years requiring EUS-guided treatment in 23 centres in Japan. This trial plans to enrol 70 patients who will be randomised at a 1:1 ratio to receive either the immediate DEN or drainage-oriented step-up approach (35 patients per arm). In the immediate DEN group, DEN will be initiated during (or within 72 h of) the EUS-guided drainage session. In the step-up approach group, drainage-based step-up treatment with on-demand DEN will be considered after 72-96 h observation. The primary endpoint is time to clinical success, which is defined as a decrease in a WON size to ≤ 3 cm and an improvement of inflammatory markers (i.e. body temperature, white blood cell count, and C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, and recurrence of the WON. DISCUSSION: The WONDER-01 trial will investigate the efficacy and safety of immediate DEN compared to the step-up approach for WON patients receiving EUS-guided treatment. The findings will help us to establish new treatment standards for patients with symptomatic WON.
trial registrationClinicalTrials.gov NCT05451901, registered on 11 July 2022. UMIN000048310, registered on 7 July 2022. jRCT1032220055, registered on 1 May 2022.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.