Pancreatitis,Acute NecrotizingDESTINNCT05043415
Randomized Trial of Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis
A study testing Immediate endoscopic necrosectomy and Step-up endoscopic interventions in people with Pancreatitis,Acute Necrotizing, run by Orlando Health, Inc. at 1 site in United States.
Trial summary
This is a randomized trial comparing immediate endoscopic necrosectomy vs. step-up endoscopic interventions in patients with necrotizing pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis,Acute Necrotizing
- What is being tested?
- Immediate endoscopic necrosectomy and Step-up endoscopic interventions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2021to 31 Dec 2023
- 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
- Age 18 years or over
- Symptomatic necrotic collection (that is suspected or confirmed to be infected), diagnosed on MRI or CT abdomen/pelvis (seen as a fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a partial or complete wall)
- Necrotic collection of any size with extent to necrosis of ≥ 33% and any number of loculations, located within the pancreatic/peri-pancreatic space
- Necrotic collection visualized on EUS and amenable to EUS-guided drainage
Who cannot join
- Age < 18 years
- Females who are pregnant
- Necrotic collection that is not amenable for EUS-guided drainage
- Irreversible coagulopathy (defined as INR >1.5, thrombocytopenia with platelet count < 50,000/mL)
- Use of anticoagulants that cannot be discontinued for the procedure
- Unable to obtain consent for the procedure from either the patient or LAR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Comparing Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis
This is a randomized trial comparing immediate endoscopic necrosectomy vs. step-up endoscopic interventions in patients with necrotizing pancreatitis.
Read the detailed description
In patients with necrotizing pancreatitis, there has been a recent shift away from surgical debridement (surgical necrosectomy) towards minimally invasive endoscopic treatment. Endoscopic management involves the creation of a fistula (tract) between the gastric or duodenal wall and the necrotic collection, under the guidance of endoscopic ultrasound (EUS) with subsequent placement of a stent. In addition, performing endoscopic necrosectomy, which involves extraction of necrotic material under direct endoscopic visualization has increased rates of treatment success to greater than 80%.
However to date, there are currently scant data on the optimal timing of endoscopic necrosectomy. The aim of this randomized trial is therefore to compare the clinical outcomes between patients undergoing immediate endoscopic necrosectomy compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for necrotizing pancreatitis.
- Conditions
- Pancreatitis,Acute Necrotizing
- Being tested
- Immediate endoscopic necrosectomy, Step-up endoscopic interventions
- 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.
Immediate endoscopic necrosectomyProcedure or surgery
In the immediate endoscopic necrosectomy group, endoscopic ultrasound-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent, immediately followed by endoscopic necrosectomy. Endoscopic necrosectomy involves removal of infected necrotic pancreatic tissue via the cystogastrostomy/cystoenterostomy tract using a variety of endoscopic accessories.
Step-up endoscopic interventionsProcedure or surgery
In the step-up endoscopic interventions group, endoscopic ultrasound-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent. Endoscopic necrosectomy is not performed during the index drainage session, but is performed at a later time as needed.
| Study group | Role | What they receive |
|---|---|---|
| Immediate endoscopic necrosectomy | Active comparator | Endoscopic ultrasound (EUS)-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent. Then in this group, endoscopic necrosectomy will be performed immediately following index EUS-guided drainage of the necrotic collection, during the same session Receives: Procedure: Immediate endoscopic necrosectomy |
| Step-up endoscopic intervention | Active comparator | Endoscopic ultrasound (EUS)-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent. In this group, only EUS-guided drainage of the necrotic collection will be performed, and endoscopic necrosectomy will be performed at a separate session at a later time as needed. Receives: Procedure: Step-up endoscopic interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of reinterventions required for treatment success
Treatment success is defined as the resolution of necrotic collection on CT scan in association with clinical resolution of symptoms at 6-month follow-up (6 months from index intervention)
Measured: 6 months
Secondary outcomes (13)
Rate of treatment success
Treatment success is defined as the resolution of necrotic collection on CT scan in association with clinical resolution of symptoms at 6-month follow-up (6 months from index intervention)
Measured: 6 months
Rate of resolution of pre-intervention systemic inflammatory response syndrome (SIRS)
Assessment of presence or absence of systemic inflammatory response syndrome prior to and 72 hours post intervention
Measured: 72 hours
Rate of resolution of at least 1 pre-intervention organ failure at 72 hours post index intervention
Assessment of presence or absence of organ failure prior to and post intervention
Measured: 72 hours
Total number of readmissions due to disease-related symptoms or procedure-related events
Assessment of readmissions due to disease-related or procedure-related events
Measured: 6 months
Rate of technical success for EUS-guided cystogastrostomy
Technical success for EUS-guided cystogastrostomy is defined as the successful placement of the cystogastrostomy stent within the necrotic collection
Measured: 24 hours
Rate of technical success for endoscopic necrosectomy
Technical success for endoscopic necrosectomy is defined as completion of endoscopic necrosectomy session as planned without the occurrence of adverse events
Measured: 24 hours
Rate of exocrine pancreatic insufficiency
Exocrine pancreatic insufficiency is defined as fecal elastase level < 200μg/g in patients not previously taking pancreatic enzyme supplements
Measured: 6 months
Rate of new onset diabetes
New onset diabetes is defined as new onset elevation in fasting plasma glucose ≥ 126 mg/dL, 2-hour plasma glucose ≥ 200 mg/dL after an oral glucose tolerance test or HbA1c ≥ 6.5%
Measured: 6 months
Rate of procedure-related adverse events
Procedure-related adverse events is defined as any adverse event occurring as a result of any endoscopic intervention
Measured: 6 months
Rate of disease-related adverse events
Disease-related adverse events is defined as any adverse event occurring as a result of necrotizing pancreatitis
Measured: 6 months
Post-procedure length of intensive care unit (ICU) stay
Post-procedure length of intensive care unit (ICU) stay is defined as the number of days of patient's admission to the ICU following index intervention
Measured: 6 months
Total length of hospital stay
Total length of hospital stay is defined as the number of days of patient's admission in the hospital following index intervention
Measured: 6 months
Overall treatment costs measured in US dollars
Overall treatment costs include all relevant costs pertaining to treatment such as procedure costs, inpatient hospital stay costs, medication costs, materials costs, anesthesia costs, pharmacy costs and imaging studies costs.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start18 Aug 2021
- Primary completion30 Jun 2023
- Study completion31 Dec 2023 (estimated)
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Asian Institute of Gastroenterology, India, West Virginia University, University of Southern California, Marshall University, Mayo Clinic, University of Alabama at Birmingham, Rush University
- Responsible party
- Sponsor
- Investigators
- Ji Young Bang, MD MPH, Principal investigator, Orlando Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043415
- Sponsor's protocol ID
- 21.067.05
- Other IDs
- 1746067
- Acronym
- DESTIN
- Status last verified
- Jul 2023
- First submitted
- 7 Sep 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bang JY, Lakhtakia S, Thakkar S, Buxbaum JL, Waxman I, Sutton B, Memon SF, Singh S, Basha J, Singh A, Navaneethan U, Hawes RH, Wilcox CM, Varadarajulu S; United States Pancreatic Disease Study Group. Upfront endoscopic necrosectomy or step-up endoscopic approach for infected necrotising pancreatitis (DESTIN): a single-blinded, multicentre, randomised trial. Lancet Gastroenterol Hepatol. 2024 Jan;9(1):22-33. doi: 10.1016/S2468-1253(23)00331-X. Epub 2023 Nov 18.
PubMed 37980922
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis
- ClinicalTrials.gov ID
- NCT05043415
- Acronym / sponsor ID
- DESTIN / 21.067.05
- Conditions
- Pancreatitis,Acute Necrotizing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Collaborators
- Asian Institute of Gastroenterology, India, West Virginia University, University of Southern California, Marshall University, Mayo Clinic, University of Alabama at Birmingham, Rush University
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Sep 2021 (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 randomized trial comparing immediate endoscopic necrosectomy vs. step-up endoscopic interventions in patients with necrotizing pancreatitis.
Detailed description
In patients with necrotizing pancreatitis, there has been a recent shift away from surgical debridement (surgical necrosectomy) towards minimally invasive endoscopic treatment. Endoscopic management involves the creation of a fistula (tract) between the gastric or duodenal wall and the necrotic collection, under the guidance of endoscopic ultrasound (EUS) with subsequent placement of a stent. In addition, performing endoscopic necrosectomy, which involves extraction of necrotic material under direct endoscopic visualization has increased rates of treatment success to greater than 80%.
However to date, there are currently scant data on the optimal timing of endoscopic necrosectomy. The aim of this randomized trial is therefore to compare the clinical outcomes between patients undergoing immediate endoscopic necrosectomy compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for necrotizing pancreatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate endoscopic necrosectomy | Active comparator | Procedure: Immediate endoscopic necrosectomyEndoscopic ultrasound (EUS)-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent. Then in this group, endoscopic necrosectomy will be performed immediately following index EUS-guided drainage of the necrotic collection, during the same session |
| Step-up endoscopic intervention | Active comparator | Procedure: Step-up endoscopic interventionsEndoscopic ultrasound (EUS)-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent. In this group, only EUS-guided drainage of the necrotic collection will be performed, and endoscopic necrosectomy will be performed at a separate session at a later time as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or over
- Symptomatic necrotic collection (that is suspected or confirmed to be infected), diagnosed on MRI or CT abdomen/pelvis (seen as a fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a partial or complete wall)
- Necrotic collection of any size with extent to necrosis of ≥ 33% and any number of loculations, located within the pancreatic/peri-pancreatic space
- Necrotic collection visualized on EUS and amenable to EUS-guided drainage
Key exclusion criteria (6 listed)
- Age < 18 years
- Females who are pregnant
- Necrotic collection that is not amenable for EUS-guided drainage
- Irreversible coagulopathy (defined as INR >1.5, thrombocytopenia with platelet count < 50,000/mL)
- Use of anticoagulants that cannot be discontinued for the procedure
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 |
|---|---|---|
| Immediate endoscopic necrosectomyIn the immediate endoscopic necrosectomy group, endoscopic ultrasound-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent, immediately followed by endoscopic necrosectomy. Endoscopic necrosectomy involves removal of infected necrotic pancreatic tissue via the cystogastrostomy/cystoenterostomy tract using a variety of endoscopic accessories. | Procedure or surgery | Immediate endoscopic necrosectomy |
| Step-up endoscopic interventionsIn the step-up endoscopic interventions group, endoscopic ultrasound-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent. Endoscopic necrosectomy is not performed during the index drainage session, but is performed at a later time as needed. | Procedure or surgery | Step-up endoscopic intervention |
Primary outcome
Total number of reinterventions required for treatment success
Time frame: 6 months
Treatment success is defined as the resolution of necrotic collection on CT scan in association with clinical resolution of symptoms at 6-month follow-up (6 months from index intervention)
13 secondary outcomes
Rate of treatment success
Time frame: 6 months
Rate of resolution of pre-intervention systemic inflammatory response syndrome (SIRS)
Time frame: 72 hours
Rate of resolution of at least 1 pre-intervention organ failure at 72 hours post index intervention
Time frame: 72 hours
Total number of readmissions due to disease-related symptoms or procedure-related events
Time frame: 6 months
Rate of technical success for EUS-guided cystogastrostomy
Time frame: 24 hours
Rate of technical success for endoscopic necrosectomy
Time frame: 24 hours
Rate of exocrine pancreatic insufficiency
Time frame: 6 months
Rate of new onset diabetes
Time frame: 6 months
Rate of procedure-related adverse events
Time frame: 6 months
Rate of disease-related adverse events
Time frame: 6 months
Post-procedure length of intensive care unit (ICU) stay
Time frame: 6 months
Total length of hospital stay
Time frame: 6 months
Overall treatment costs measured in US dollars
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Derived from this study: PubMed 37980922Bang JY, Lakhtakia S, Thakkar S, Buxbaum JL, Waxman I, Sutton B, Memon SF, Singh S, Basha J, Singh A, Navaneethan U, Hawes RH, Wilcox CM, Varadarajulu S; United States Pancreatic Disease Study Group. Upfront endoscopic necrosectomy or step-up endoscopic approach for infected necrotising pancreatitis (DESTIN): a single-blinded, multicentre, randomised trial. Lancet Gastroenterol Hepatol. 2024 Jan;9(1):22-33. doi: 10.1016/S2468-1253(23)00331-X. Epub 2023 Nov 18.
- Individual participant dataSharing planned: No
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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.
Ji Young Bang, MD MPH principal investigator
Orlando Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate endoscopic necrosectomy and Step-up endoscopic interventions in people with Pancreatitis,Acute Necrotizing, run by Orlando Health, Inc. 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 6 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: status not confirmed, as of the sponsor's last update on 1 Aug 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 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?
Results are not available in the source record.
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?
Total number of reinterventions required for treatment success (time frame: 6 months). 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 NCT05043415, 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 1 Aug 2023.