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

Not Applicable

Completed

• Conditions: Walled Off Necrosis; Pancreatitis, Acute Necrotizing
• Interventions: Procedure: EUS-guided drainage using LAMS with DPS; Procedure: EUS-guided drainage using LAMS alone

• Registration Number: NCT03923686
• Lead Sponsor: Palacky University

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.

Study Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-22
• Study Start: 2019-05-13
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-01
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAMS plus DPS	EUS-guided drainage using LAMS with 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).
LAMS alone	EUS-guided drainage using LAMS alone	Endoscopic ultrasound-guided (EUS) transmural drainage of walled-off pancreatic necrosis (WON) using lumen-apposing metal stent (LAMS) alone.

Primary Outcome Measures

Name	Time	Method
Failure of method	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	up to 12 months	Overall mortality during subsequent follow-up

Secondary Outcome Measures

Name	Time	Method
Adverse events	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).
Recurrence rate	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.
Clinical success rate	up to 1 month	Resolution of the collection and symptoms following endoscopic drainage with LAMS before its extraction.
Number of procedures	up to 1 month	Number of forced endoscopic interventions (direct endoscopic necrosectomy, debridement, desobliteration, etc.) required to achieve resolution.
Hospital stay	up to 1 month	Total length of hospital stay within the period following LAMS insertion until its extraction.
Microbiological cultivation	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.

Trial Locations

Locations (1)

University Hospital Olomouc, Second Department of Internal Medicine - Gastroenterology and Geriatrics; 🇨🇿 Olomouc, Czechia