Necrotizing PancreatitisNCT02564965
Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis
A study testing Double Pigtail Plastic Stent and AXIOS Metal Stent in people with Necrotizing Pancreatitis, run by Mayo Clinic.
Trial summary
The purpose of this study is to determine optimal treatment strategies for symptomatic walled-off pancreatic necrosis( WON). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Necrotizing Pancreatitis
- What is being tested?
- Double Pigtail Plastic Stent and AXIOS Metal Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Dec 2020
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult (> 18 yo) patients
- With symptomatic walled- off pancreatic necrosis in which an endoscopic approach is appropriate based on cross-sectional imaging
- Must have solid necrotic material present in their pancreatic fluid collection as determined by MRI, EUS, or direct transluminal endoscopic imaging of the collection
Who cannot join
- Previous intervention for pancreatic necrosis (surgical, percutaneous, or endoscopic)
- Indication for emergency laparotomy (compartment syndrome, bowel ischemia, bleeding, or perforation of a GI lumen)
- Uncorrectable coagulopathy.
About this study
Official title: Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis: A Prospective, Randomized Noninferiority Trial.
The purpose of this study is to determine optimal treatment strategies for symptomatic walled-off pancreatic necrosis( WON).
- Conditions
- Necrotizing Pancreatitis
- Being tested
- Double Pigtail Plastic Stent, AXIOS Metal Stent
- Keywords
- Acute Necrotizing Pancreatitis, Walled-Off Pancreatic Necrosis
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Pigtail Plastic StentDevice
Patients will be stratified into two arms (Greater than 50% necrosis or less than 50% necrosis), then will be randomized to either the double pigtail plastic stent or AXIOS metal stent
AXIOS Metal StentDevice
Also called LC-SEMS, Large caliber- self-expanding metal stent
Patients will be stratified into two arms (Greater than 50% necrosis or less than 50% necrosis), then will be randomized to either the double pigtail plastic stent or AXIOS metal stent
| Study group | Role | What they receive |
|---|---|---|
| Greater than 50% Necrosis | Other | Subjects who have greater than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent. Receives: Device: Double Pigtail Plastic Stent; Device: AXIOS Metal Stent |
| Less than 50% Necrosis | Other | Subjects who have less than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent. Receives: Device: Double Pigtail Plastic Stent; Device: AXIOS Metal Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resolution as defined by complete radiographic resolution of the walled-off necrosis (WON)
Measured: Baseline to 4 months after initiation of endoscopic treatment
Secondary outcomes (5)
Clinical resolution of infection as defined by complete radiographic resolution and/or symptoms of pain and gastric outlet obstruction
Measured: Baseline to 4 months after initiation of endoscopic treatment
Symptom resolution (Visual Analogue Scale for pain, gastric outlet obstruction, and weight gain)
Measured: Baseline to 4 months after initiation of endoscopic treatment
Decrease in incidence of adverse events
Measured: Baseline to 4 months after initiation of endoscopic treatment
Decrease in number of hospital days during treatment course
Measured: Baseline to 4 months after initiation of endoscopic treatment
Decrease in total costs of pancreatitis-related health care during treatment course
Measured: Baseline to 4 months after initiation of endoscopic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startFeb 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing PancreatitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barham K. Abu Dayyeh, M.D., Mayo Clinic
- Investigators
- Barham Abu Dayyeh, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564965
- Sponsor's protocol ID
- 14-001390
- Status last verified
- Apr 2019
- First submitted
- 29 Sep 2015
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis: A Prospective, Randomized Noninferiority Trial.
- ClinicalTrials.gov ID
- NCT02564965
- Acronym / sponsor ID
- 14-001390
- Conditions
- Necrotizing Pancreatitis
- Keywords
- Acute Necrotizing Pancreatitis, Walled-Off Pancreatic Necrosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Oct 2015 (estimated)
- 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.
The purpose of this study is to determine optimal treatment strategies for symptomatic walled-off pancreatic necrosis( WON).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Greater than 50% Necrosis | Other | Device: Double Pigtail Plastic Stent, Device: AXIOS Metal StentSubjects who have greater than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent. |
| Less than 50% Necrosis | Other | Device: Double Pigtail Plastic Stent, Device: AXIOS Metal StentSubjects who have less than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult (> 18 yo) patients
- With symptomatic walled- off pancreatic necrosis in which an endoscopic approach is appropriate based on cross-sectional imaging
- Must have solid necrotic material present in their pancreatic fluid collection as determined by MRI, EUS, or direct transluminal endoscopic imaging of the collection
Key exclusion criteria (3 listed)
- Previous intervention for pancreatic necrosis (surgical, percutaneous, or endoscopic)
- Indication for emergency laparotomy (compartment syndrome, bowel ischemia, bleeding, or perforation of a GI lumen)
- Uncorrectable coagulopathy.
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 |
|---|---|---|
| Double Pigtail Plastic StentPatients will be stratified into two arms (Greater than 50% necrosis or less than 50% necrosis), then will be randomized to either the double pigtail plastic stent or AXIOS metal stent | Device | Greater than 50% Necrosis, Less than 50% Necrosis |
| AXIOS Metal StentAlso: LC-SEMS, Large caliber- self-expanding metal stentPatients will be stratified into two arms (Greater than 50% necrosis or less than 50% necrosis), then will be randomized to either the double pigtail plastic stent or AXIOS metal stent | Device | Greater than 50% Necrosis, Less than 50% Necrosis |
Primary outcome
Complete resolution as defined by complete radiographic resolution of the walled-off necrosis (WON)
Time frame: Baseline to 4 months after initiation of endoscopic treatment
5 secondary outcomes
Clinical resolution of infection as defined by complete radiographic resolution and/or symptoms of pain and gastric outlet obstruction
Time frame: Baseline to 4 months after initiation of endoscopic treatment
Symptom resolution (Visual Analogue Scale for pain, gastric outlet obstruction, and weight gain)
Time frame: Baseline to 4 months after initiation of endoscopic treatment
Decrease in incidence of adverse events
Time frame: Baseline to 4 months after initiation of endoscopic treatment
Decrease in number of hospital days during treatment course
Time frame: Baseline to 4 months after initiation of endoscopic treatment
Decrease in total costs of pancreatitis-related health care during treatment course
Time frame: Baseline to 4 months after initiation of endoscopic treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Barham Abu Dayyeh, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Double Pigtail Plastic Stent and AXIOS Metal Stent in people with Necrotizing Pancreatitis, run by Mayo Clinic.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Complete resolution as defined by complete radiographic resolution of the walled-off necrosis (WON) (time frame: Baseline to 4 months after initiation of endoscopic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2019.