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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03923686
Recruitment Status Recruiting
First Posted April 22, 2019
Last update posted April 2, 2020
A prospective randomized cohort study to compare whether the placement of a double-pigtail plastic stent (DPS) within a lumen-apposing metal stent (LAMS) may improve the efficacy and safety of endoscopic ultrasound guided transmural drainage of walled-off pancreatic necrosis (WON) and thus prevent potential adverse events related to LAMS insertion.
The aim of the study is to compare endoscopic ultrasound guided transmural drainage using lumen-apposing metal stent with (1.) or without (2.) coaxial plastic stent in the management of walled-off pancreatic necrosis. The usage of LAMS has been evaluated as a safe and effective method for the drainage of walled-off pancreatic necrosis in various studies. However, complications such as bleeding, infection due to stent obstruction, stent migration, or buried stent syndrome have been reported. A preventive measure to minimize adverse events related to LAMS insertion by means of placing an anchoring DPS through the LAMS have been suggested but there has been no prospective randomized study to assess the utility of such measure to date. The study is to be conducted at a tertiary institution with an expertise in treating hepato-pancreato-biliary diseases. The main timeframe of the study is 3 weeks following LAMS insertion with or without DPS. All LAMS will be extracted 3 weeks after the initial procedure. The extraction will be preceded by a CT scan of the abdomen to assess whether the DPS needs to be left in place/ inserted in patients with incomplete resolution of the collection. In addition, material from the collection will be collected for cultivation at every endoscopic intervention to assess colonization by microbial flora over time. All patients will be closely followed with clinical, laboratory, and radiological assessment for 12 months in total. Our experience has shown failure of the (2.) method in 70 % of patients so far. Assuming a clinically significant difference to be a reduction to 40 % in failed patients using the (1) method, the required study population size was calculated to 62 patients (31 in both arms) by power analysis (at standard alpha and beta values). The final number was set to 70 as a safety measure.
|Experimental: LAMS plus DPS
Endoscopic ultrasound-guided (EUS) transmural drainage of walled-off pancreatic necrosis (WON) using lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPS).
Procedure: EUS-guided drainage using LAMS with DPS
Endoscopic ultrasound-guided drainage using lumen-apposing metal stent with coaxial plastic stent in the treatment of walled-off pancreatic necrosis.
|Active Comparator: LAMS alone
Endoscopic ultrasound-guided (EUS) transmural drainage of walled-off pancreatic necrosis (WON) using lumen-apposing metal stent (LAMS) alone.
Procedure: EUS-guided drainage using LAMS alone
Endoscopic ultrasound-guided drainage using lumen-apposing metal stent without coaxial plastic stent in the treatment of walled-off pancreatic necrosis.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- walled-off pancreatic necrosis (WON) indicated for endoscopical drainage
- signed informed consent form
- patient disagreement with the study
- types of collections other than WON
- drainage with stents other than LAMS
- previous attempts at drainage of WON
- severe coagulopathy or thrombocytopenia
Contact: Petr Vanek, MD +420 58844 4803 firstname.lastname@example.org
Contact: Premysl Falt, MD, Ph.D. email@example.com
University Hospital Olomouc, Second Department of Internal Medicine - Gastroenterology and Geriatrics
Principal Investigator: Petr Vanek, MD Assistant Professor, physician