Pancreatitis, Acute NecrotizingNCT03923686
Lumen-apposing Metal Stent With or Without Coaxial Plastic Stent for Treatment of Walled-off Pancreatic Necrosis
A study testing EUS-guided drainage using LAMS with DPS and EUS-guided drainage using LAMS alone in people with Pancreatitis, Acute Necrotizing and Walled Off Necrosis, run by Palacky University at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Acute Necrotizing, Walled Off Necrosis
- What is being tested?
- EUS-guided drainage using LAMS with DPS and EUS-guided drainage using LAMS alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteCzechia
- Study dates
- 13 May 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- walled-off pancreatic necrosis (WON) indicated for endoscopical drainage
- signed informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Olomouc, Second Department of Internal Medicine - Gastroenterology and Geriatrics
Olomouc, 77900
About this study
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
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.
Read the 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.
- Being tested
- EUS-guided drainage using LAMS with DPS, EUS-guided drainage using LAMS alone
- Keywords
- Walled off necrosis, Acute pancreatitis, Necrotizing pancreatitis, Endoscopic drainage, Lumen apposing metal stents, Double pigtail plastic stent
- Medical subject headings
- Pancreatitis, Acute Necrotizing, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided drainage using LAMS with DPSProcedure or surgery
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 aloneProcedure or surgery
Endoscopic ultrasound-guided drainage using lumen-apposing metal stent without coaxial plastic stent in the treatment of walled-off pancreatic necrosis.
| Study group | Role | What they receive |
|---|---|---|
| LAMS plus DPS | Experimental | 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). Receives: Procedure: EUS-guided drainage using LAMS with DPS |
| LAMS alone | Active comparator | Endoscopic ultrasound-guided (EUS) transmural drainage of walled-off pancreatic necrosis (WON) using lumen-apposing metal stent (LAMS) alone. Receives: Procedure: EUS-guided drainage using LAMS alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 month
Mortality
Overall mortality during subsequent follow-up
Measured: up to 12 months
Secondary outcomes (6)
Clinical success rate
Resolution of the collection and symptoms following endoscopic drainage with LAMS before its extraction.
Measured: up to 1 month
Adverse events
Primarily complications caused by LAMS itself (bleeding due to vessel erosion, secondary infection due to stent obstruction, stent migration, buried stent syndrome).
Measured: up to 1 month
Number of procedures
Number of forced endoscopic interventions (direct endoscopic necrosectomy, debridement, desobliteration, etc.) required to achieve resolution.
Measured: up to 1 month
Hospital stay
Total length of hospital stay within the period following LAMS insertion until its extraction.
Measured: up to 1 month
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.
Measured: up to 12 months
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.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start13 May 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, Acute NecrotizingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a prospective randomized cohort study
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Vanek, Palacky University
- Investigators
- Petr Vanek, MD, Principal investigator, Assistant Professor, physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923686
- Sponsor's protocol ID
- FNOL 2IK 001
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2019
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vanek P, Falt P, Vitek P, Zoundjiekpon V, Horinkova M, Zapletalova J, Lovecek M, Urban O. EUS-guided transluminal drainage using lumen-apposing metal stents with or without coaxial plastic stents for treatment of walled-off necrotizing pancreatitis: a prospective bicentric randomized controlled trial. Gastrointest Endosc. 2023 Jun;97(6):1070-1080. doi: 10.1016/j.gie.2022.12.026. Epub 2023 Jan 13.
PubMed 36646148
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03923686
- Acronym / sponsor ID
- FNOL 2IK 001
- Keywords
- Walled off necrosis, Acute pancreatitis, Necrotizing pancreatitis, Endoscopic drainage, Lumen apposing metal stents, Double pigtail plastic stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a prospective randomized cohort study
| Arm | Type | Receives |
|---|---|---|
| LAMS plus DPS | Experimental | Procedure: EUS-guided drainage using LAMS with DPSEndoscopic 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 | Active comparator | Procedure: EUS-guided drainage using LAMS aloneEndoscopic ultrasound-guided (EUS) transmural drainage of walled-off pancreatic necrosis (WON) using lumen-apposing metal stent (LAMS) alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- walled-off pancreatic necrosis (WON) indicated for endoscopical drainage
- signed informed consent form
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-guided drainage using LAMS with DPSEndoscopic ultrasound-guided drainage using lumen-apposing metal stent with coaxial plastic stent in the treatment of walled-off pancreatic necrosis. | Procedure or surgery | LAMS plus DPS |
| EUS-guided drainage using LAMS aloneEndoscopic ultrasound-guided drainage using lumen-apposing metal stent without coaxial plastic stent in the treatment of walled-off pancreatic necrosis. | Procedure or surgery | LAMS alone |
Primary outcome
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
6 secondary outcomes
Clinical success rate
Time frame: up to 1 month
Adverse events
Time frame: up to 1 month
Number of procedures
Time frame: up to 1 month
Hospital stay
Time frame: up to 1 month
Recurrence rate
Time frame: up to 12 months
Microbiological cultivation
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 36646148Vanek P, Falt P, Vitek P, Zoundjiekpon V, Horinkova M, Zapletalova J, Lovecek M, Urban O. EUS-guided transluminal drainage using lumen-apposing metal stents with or without coaxial plastic stents for treatment of walled-off necrotizing pancreatitis: a prospective bicentric randomized controlled trial. Gastrointest Endosc. 2023 Jun;97(6):1070-1080. doi: 10.1016/j.gie.2022.12.026. Epub 2023 Jan 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Vanek, MD principal investigator
Assistant Professor, physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided drainage using LAMS with DPS and EUS-guided drainage using LAMS alone in people with Pancreatitis, Acute Necrotizing and Walled Off Necrosis, run by Palacky University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of method (time frame: up to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03923686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.