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

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ClinicalTrials.gov Identifier: NCT03923686
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Petr Vanek, 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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a prospective randomized cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. Mortality [ Time Frame: up to 12 months ]
    Overall mortality during subsequent follow-up


Secondary Outcome Measures :
  1. Clinical success rate [ Time Frame: up to 1 month ]
    Resolution of the collection and symptoms following endoscopic drainage with LAMS before its extraction.

  2. 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).

  3. Number of procedures [ Time Frame: up to 1 month ]
    Number of forced endoscopic interventions (direct endoscopic necrosectomy, debridement, desobliteration, etc.) required to achieve resolution.

  4. Hospital stay [ Time Frame: up to 1 month ]
    Total length of hospital stay within the period following LAMS insertion until its extraction.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Petr Vanek, MD +420 58844 4803 petr.vanek3@fnol.cz
Contact: Premysl Falt, MD, Ph.D. premysl.falt@fnol.cz

Locations
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Czechia
University Hospital Olomouc, Second Department of Internal Medicine - Gastroenterology and Geriatrics Recruiting
Olomouc, Czechia, 77900
Contact: Petr Vanek, MD         
Sponsors and Collaborators
Palacky University
Investigators
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Principal Investigator: Petr Vanek, MD Assistant Professor, physician

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Responsible Party: Petr Vanek, Principal Investigator, Palacky University
ClinicalTrials.gov Identifier: NCT03923686     History of Changes
Other Study ID Numbers: FNOL 2IK 001
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Petr Vanek, Palacky University:
Walled off necrosis
Acute pancreatitis
Necrotizing pancreatitis
Endoscopic drainage
Lumen apposing metal stents
Double pigtail plastic stent

Additional relevant MeSH terms:
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Pancreatitis
Necrosis
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Digestive System Diseases
Pathologic Processes