Walled Off Pancreatic Necrosis (WON)NCT03801070
Rad Predictors for WON
An observational study of Walled Off Pancreatic Necrosis (WON), run by Washington University School of Medicine at 1 site in United States.
Trial summary
This is a retrospective chart review study examining 1) demographic data such as age, sex, etiology of pancreatitis 2) clinical data including radiological characteristics of walled off pancreatic necrosis, walled off necrosis related admissions and readmission following endoscopic drainage, surgical or percutaneous… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Walled Off Pancreatic Necrosis (WON)
- What is being tested?
- endoscopic drainage of walled off pancreatic necrosis
- Type of treatment
- Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2017to 1 Dec 2017
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with organized collections that contain both solid and liquid debris and arise from necrotizing pancreatitis, referred to as walled off pancreatic necrosis (WON)
Who may be able to join
- Patients over 18 years of age who underwent endoscopic drainage of walled off pancreatic necrosis
- Patients who did not require further intervention (either surgical, percutaneous, or endoscopic) following endoscopic drainage
- Patients who required further intervention for walled off pancreatic necrosis (either surgical, percutaneous, or endoscopic) following endoscopic drainage.
- Patients who underwent percutaneous or surgical interventions prior to endoscopic drainage
Who cannot join
- Pancreatic pseudocysts without any solid debris
- Under 18 years of age at the time of endoscopic drainage
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine in St Louis
St Louis, Missouri, 63010
About this study
Official title: Radiological Predictors of Failure of Endoscopic Therapy or Need For Multiple Endoscopic Procedures in Patients With Walled Off Pancreatic Necrosis
This is a retrospective chart review study examining 1) demographic data such as age, sex, etiology of pancreatitis 2) clinical data including radiological characteristics of walled off pancreatic necrosis, walled off necrosis related admissions and readmission following endoscopic drainage, surgical or percutaneous procedures performed for the management of walled off pancreatic necrosis, and clinical outcomes following treatment of WON (including hospital readmissions, WON resolution, procedure complications, WON related death) 3) endoscopy data including indication for initial endoscopic drainage and subsequent endoscopic procedures performed for management of walled off necrosis (including additional EGD's, endoscopic drainage procedures, and/or necrosectomy)
- Conditions
- Walled Off Pancreatic Necrosis (WON)
- Being tested
- endoscopic drainage of walled off pancreatic necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic drainage of walled off pancreatic necrosisProcedure or surgery
transmural drainage and mechanical debridement of solid debris (necrosectomy)
| Study group | Role | What they receive |
|---|---|---|
| Less than median number necrosectomies | Group one includes patients who underwent less than median number necrosectomies Receives: Procedure: endoscopic drainage of walled off pancreatic necrosis | |
| At least the median number of necrosectomies | Group two includes patients who underwent at least the median number of necrosectomies Receives: Procedure: endoscopic drainage of walled off pancreatic necrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify WON imaging characteristics on cat-scan
Characteristics on cat-scan that are predictive of requiring multiple endoscopic procedures, percutaneous drainage, and/or surgical intervention for management of walled off pancreatic necrosis
Measured: through study completion, an average of 260 days
Endoscopic course (total number and type of endoscopic treatments required for resolution of walled off necrosis, occurrence of treatment related complications)
Imaging classification method to efficiently report these imaging characteristics
Measured: through study completion, an average of 260 days
Clinical course (number of hospital readmissions during treatment, rates of walled off necrosis resolution, rates of walled off necrosis related death)
Characteristics to develop a predictive model that will help to identify patients at high risk for requiring multiple endoscopic procedures, percutaneous drainage, and/or surgical intervention for management of walled off pancreatic necrosis.
Measured: through study completion, an average of 260 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start14 Jul 2017
- Primary completion1 Sep 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Walled Off Pancreatic Necrosis (WON)Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma Medical Center, Northwestern University, St. Luke's Hospital, Kansas City, Missouri
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801070
- Sponsor's protocol ID
- 201707053
- Status last verified
- Jul 2019
- First submitted
- 3 Jan 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Predictors of Failure of Endoscopic Therapy or Need For Multiple Endoscopic Procedures in Patients With Walled Off Pancreatic Necrosis
- ClinicalTrials.gov ID
- NCT03801070
- Acronym / sponsor ID
- 201707053
- Conditions
- Walled Off Pancreatic Necrosis (WON)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Oklahoma Medical Center, Northwestern University, St. Luke's Hospital, Kansas City, Missouri
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 11 Jan 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.
This is a retrospective chart review study examining 1) demographic data such as age, sex, etiology of pancreatitis 2) clinical data including radiological characteristics of walled off pancreatic necrosis, walled off necrosis related admissions and readmission following endoscopic drainage, surgical or percutaneous procedures performed for the management of walled off pancreatic necrosis, and clinical outcomes following treatment of WON (including hospital readmissions, WON resolution, procedure complications, WON related death) 3) endoscopy data including indication for initial endoscopic drainage and subsequent endoscopic procedures performed for management of walled off necrosis (including additional EGD's, endoscopic drainage procedures, and/or necrosectomy)
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Less than median number necrosectomies | – | Procedure: endoscopic drainage of walled off pancreatic necrosisGroup one includes patients who underwent less than median number necrosectomies |
| At least the median number of necrosectomies | – | Procedure: endoscopic drainage of walled off pancreatic necrosisGroup two includes patients who underwent at least the median number of necrosectomies |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with organized collections that contain both solid and liquid debris and arise from necrotizing pancreatitis, referred to as walled off pancreatic necrosis (WON)
Key inclusion criteria (4 listed)
- Patients over 18 years of age who underwent endoscopic drainage of walled off pancreatic necrosis
- Patients who did not require further intervention (either surgical, percutaneous, or endoscopic) following endoscopic drainage
- Patients who required further intervention for walled off pancreatic necrosis (either surgical, percutaneous, or endoscopic) following endoscopic drainage.
- Patients who underwent percutaneous or surgical interventions prior to endoscopic drainage
Key exclusion criteria (2 listed)
- Pancreatic pseudocysts without any solid debris
- Under 18 years of age at the time of endoscopic drainage
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 |
|---|---|---|
| endoscopic drainage of walled off pancreatic necrosistransmural drainage and mechanical debridement of solid debris (necrosectomy) | Procedure or surgery | At least the median number of necrosectomies, Less than median number necrosectomies |
Primary outcome
Identify WON imaging characteristics on cat-scan
Time frame: through study completion, an average of 260 days
Characteristics on cat-scan that are predictive of requiring multiple endoscopic procedures, percutaneous drainage, and/or surgical intervention for management of walled off pancreatic necrosis
Endoscopic course (total number and type of endoscopic treatments required for resolution of walled off necrosis, occurrence of treatment related complications)
Time frame: through study completion, an average of 260 days
Imaging classification method to efficiently report these imaging characteristics
Clinical course (number of hospital readmissions during treatment, rates of walled off necrosis resolution, rates of walled off necrosis related death)
Time frame: through study completion, an average of 260 days
Characteristics to develop a predictive model that will help to identify patients at high risk for requiring multiple endoscopic procedures, percutaneous drainage, and/or surgical intervention for management of walled off pancreatic necrosis.
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 23 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Walled Off Pancreatic Necrosis (WON)
Recruiting
The Effect of Proton Pump Inhibitors(PPIs) on Endoscopic Treatment of Walled-off Necrosis (WON)
Pancreatic Walled-off Necrosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Walled Off Pancreatic Necrosis (WON), run by Washington University School of Medicine at 1 site in United States.
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 4 inclusion and 2 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 23 Jul 2019. 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 United States. 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?
Identify WON imaging characteristics on cat-scan (time frame: through study completion, an average of 260 days). The study lists 3 primary outcomes in all. 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 23 Jul 2019.