Lumen-apposing Metal Stent With or Without Coaxial Plastic Stent for Treatment of Walled-off Pancreatic Necrosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03923686|
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis, Acute Necrotizing Walled Off Necrosis||Procedure: EUS-guided drainage using LAMS with DPS Procedure: EUS-guided drainage using LAMS alone||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||a prospective randomized cohort study|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Ultrasound-guided Drainage Using Lumen-apposing Metal Stent With or Without Coaxial Plastic Stent for Treatment of Walled-off Pancreatic Necrosis: a Prospective Randomised Study|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||May 2022|
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.
- Failure of method [ Time Frame: up to 1 month ]Defined as a necessity of re-intervention (endoscopic, surgical, percutaneous) within the period following LAMS insertion and before its planned extraction due to complications related to LAMS insertion and/or clinical deterioration.
- Mortality [ Time Frame: up to 12 months ]Overall mortality during subsequent follow-up
- Clinical success rate [ Time Frame: up to 1 month ]Resolution of the collection and symptoms following endoscopic drainage with LAMS before its extraction.
- Adverse events [ Time Frame: up to 1 month ]Primarily complications caused by LAMS itself (bleeding due to vessel erosion, secondary infection due to stent obstruction, stent migration, buried stent syndrome).
- Number of procedures [ Time Frame: up to 1 month ]Number of forced endoscopic interventions (direct endoscopic necrosectomy, debridement, desobliteration, etc.) required to achieve resolution.
- Hospital stay [ Time Frame: up to 1 month ]Total length of hospital stay within the period following LAMS insertion until its extraction.
- Recurrence rate [ Time Frame: up to 12 months ]Recurrence of the collection accompanied by symptoms provided there had been previous clinical success with documented resolution of the collection by radiological studies.
- Microbiological cultivation [ Time Frame: up to 1 month ]Material from the collection will be collected at every endoscopic intervention (at least during insertion and extraction of LAMS) to assess colonization by microbial flora over time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923686
|Contact: Petr Vanek, MD||+420 58844 firstname.lastname@example.org|
|Contact: Premysl Falt, MD, Ph.D.||email@example.com|
|University Hospital Olomouc, Second Department of Internal Medicine - Gastroenterology and Geriatrics||Not yet recruiting|
|Olomouc, Czechia, 77900|
|Contact: Petr Vanek, MD|
|Principal Investigator:||Petr Vanek, MD||Assistant Professor, physician|