Clinical trial NCT03923686: Lumen-apposing Metal Stent With or Without Coaxial Plastic Stent for Treatment of Walled-off Pancreatic Necrosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatitis, Acute Necrotizing
Walled Off Necrosis
Keywords: Walled off necrosis
Acute pancreatitis
Necrotizing pancreatitis
Endoscopic drainage
Lumen apposing metal stents
Double pigtail plastic stent
Lead sponsor: Palacky University
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a prospective randomized cohort study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* walled-off pancreatic necrosis (WON) indicated for endoscopical drainage
* signed informed consent form

Exclusion Criteria:

* 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

Primary outcomes:
measure: Failure of method
timeFrame: up to 1 month
measure: Mortality
timeFrame: up to 12 months
Secondary outcomes:
measure: Clinical success rate
timeFrame: up to 1 month
measure: Adverse events
timeFrame: up to 1 month
measure: Number of procedures
timeFrame: up to 1 month
measure: Hospital stay
timeFrame: up to 1 month
measure: Recurrence rate
timeFrame: up to 12 months
measure: Microbiological cultivation
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: University Hospital Olomouc, Second Department of Internal Medicine - Gastroenterology and Geriatrics
Study officials:
affiliation: Assistant Professor, physician
name: Petr Vanek, MD
role: PRINCIPAL_INVESTIGATOR
References: