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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

Tracking Information
First Submitted Date  ICMJE April 12, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date June 7, 2019
Actual Study Start Date  ICMJE May 13, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03923686 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lumen-apposing Metal Stent With or Without Coaxial Plastic Stent for Treatment of Walled-off Pancreatic Necrosis
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
a prospective randomized cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatitis, Acute Necrotizing
  • Walled Off Necrosis
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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).
    Intervention: Procedure: EUS-guided drainage using LAMS with DPS
  • Active Comparator: LAMS alone
    Endoscopic ultrasound-guided (EUS) transmural drainage of walled-off pancreatic necrosis (WON) using lumen-apposing metal stent (LAMS) alone.
    Intervention: Procedure: EUS-guided drainage using LAMS alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2019)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Petr Vanek, MD +420 58844 4803 petr.vanek3@fnol.cz
Contact: Premysl Falt, MD, Ph.D. premysl.falt@fnol.cz
Listed Location Countries  ICMJE Czechia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03923686
Other Study ID Numbers  ICMJE FNOL 2IK 001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Petr Vanek, Palacky University
Study Sponsor  ICMJE Palacky University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Petr Vanek, MD Assistant Professor, physician
PRS Account Palacky University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP