Lumen-apposing Metal Stent With or Without Coaxial Plastic Stent for Treatment of Walled-off Pancreatic Necrosis

Pancreatitis, Acute Necrotizing Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923686
• Other study ID #: FNOL 2IK 001
• Status: Completed
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Palacky University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Necrosis
• Pancreatitis
• Pancreatitis, Acute Necrotizing
• Walled Off Necrosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Czechia	University Hospital Olomouc, Second Department of Internal Medicine - Gastroenterology and Geriatrics	Olomouc

Sponsors (1)

Lead Sponsor	Collaborator
Palacky University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure of method	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.	up to 1 month
Primary	Mortality	Overall mortality during subsequent follow-up	up to 12 months
Secondary	Clinical success rate	Resolution of the collection and symptoms following endoscopic drainage with LAMS before its extraction.	up to 1 month
Secondary	Adverse events	Primarily complications caused by LAMS itself (bleeding due to vessel erosion, secondary infection due to stent obstruction, stent migration, buried stent syndrome).	up to 1 month
Secondary	Number of procedures	Number of forced endoscopic interventions (direct endoscopic necrosectomy, debridement, desobliteration, etc.) required to achieve resolution.	up to 1 month
Secondary	Hospital stay	Total length of hospital stay within the period following LAMS insertion until its extraction.	up to 1 month
Secondary	Recurrence rate	Recurrence of the collection accompanied by symptoms provided there had been previous clinical success with documented resolution of the collection by radiological studies.	up to 12 months
Secondary	Microbiological cultivation	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.	up to 1 month