Back to resultsEndoscopic Necrosectomy Versus Step-up Endoscopic Intervention (DESTIN)
Primary Purpose
Pancreatic Necrosis, Necrosis Pancreas
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Direct Endoscopic Intervention
Step-up Endoscopic Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Necrosis focused on measuring pancreatic necrosis, pancreatic necrotic collection, transenteric drainage, necrosectomy
Eligibility Criteria
Inclusion Criteria:
- The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements
- The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures
- Males or females ≥ 18 years of age
- Necrotic collection 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 ≥ 33% of solid/necrotic component and any no. of loculations, located within the pancreatic/peri-pancreatic space
- Necrotic collection visualized on EUS and amenable to EUS-guided drainage
- Suspected/confirmed infected necrotic collection. Infected necrosis is defined by the presence of gas in the necrotic collection on cross-sectional imaging or positive culture of necrotic tissue obtained preprocedure or at first intervention. Infected necrosis is also suspected when sepsis is persistent or in the presence of ongoing clinical deterioration.
Documented history of acute pancreatitis Acute pancreatitis is diagnosed if 2 of the following 3 criteria are met
- Abdominal pain characteristic of acute pancreatitis
- Serum lipase/amylase ≥ x3 upper limit of normal
- Characteristic radiological findings of acute pancreatitis on CECT/MRI/US abdomen, such as homogeneous enhancement of pancreatic parenchyma, standing of peripancreatic fat
- Able to undergo general anesthesia
Exclusion Criteria:
- Females who are pregnant or lactating. Pregnancy for females of childbearing potential will be determined by routine preoperative urine or serum HCG testing.
- Irreversible coagulopathy (INR >1.5, thrombocytopenia with platelet count <50,000/mL)
- Has surgically altered gastrointestinal anatomy such as but not limited to Billroth II, Roux-en-Y, gastric bypass
- Age < 18 years
- Unable to obtain consent for the procedure from either the patient or LAR
- Use of anticoagulants that cannot be discontinued for the procedure
- Unable to tolerate general anesthesia
- Necrotic collection that is not accessible for EUS-guided drainage
- Percutaneous drainage of the necrotic collection is required or performed prior to EUS-guided drainage
Sites / Locations
- Center for Interventional Endoscopy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Direct Endoscopic Necrosectomy
Step-up Endoscopic Interventions
Arm Description
The subject will have endoscopic drainage and necrosectomy at the time of the index intervention.
The subject will only have endoscopic drainage of the pancreatic necrotic collection at the time of index intervention.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Rate of resolution of pre-intervention systemic inflammatory response syndrome
Assessment of preintervention systemic inflammatory response syndrome & their resolution and measured by yes/no.
Rate of resolution of at least 1 pre-intervention organ failure
Assessment of organ failure following the index procedure and their resolution and measured by yes/no.
Number of re-admissions
Assessing the total number of re-admissions following the index procedure.
Rate of technical success for EUS-guided cystogastrostomy
Technical success for EUS-guided cystogastrostomy defined as completion of endoscopic necrosectomy session as planned without the occurrence of adverse events and measured by yes/no.
Rate of technical success for endoscopic necrosectomy
Technical success for endoscopic necrosectomy defined as any adverse event occurring as a result of necrotizing pancreatitis and measured by yes/no.
Rate of exocrine pancreatic insufficiency
Rate of exocrine pancreatic insufficiency defined as fecal elastase level < 200μg/g in patients not previously taking pancreatic enzyme supplements
Rate of new onset diabetes
Rate of new onset diabetes 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%
Number of Procedure-related adverse events
Procedure-related adverse events defined as any adverse event occurring as a result of any endoscopic intervention. The subject will be asked to report and medical records will be reviewed for any adverse events related to the procedure.
Number of Disease-related adverse events
Disease-related adverse events, defined as any adverse event occurring as a result of necrotizing pancreatitis. The subject will be asked to report and medical records will be reviewed for any adverse events related to the procedure.
Post-procedure length of intensive care unit (ICU) stay
Measured in the number of days in the intensive care unit
Total length of hospital stay
Measured in the number of days in the hospital
Overall treatment costs
Overall treatment costs from admission until 6 months post index intervention. All relevant costs pertaining to treatment will be taken into consideration - procedure costs, inpatient hospital stay from date of procedure to discharge, readmissions, medications, materials, anesthesia, pharmacy and imaging studies.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04113499
Brief Title
Endoscopic Necrosectomy Versus Step-up Endoscopic Intervention
Acronym
DESTIN
Official Title
A Randomized Trial Comparing Direct Endoscopic Necrosectomy vs. Step-up Transluminal Endoscopic Interventions in Infected Necrotizing Pancreatitis (DESTIN)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 27, 2019 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
April 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This trial is to compare clinical outcomes between patients undergoing immediate endoscopic necrosectomy compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for infected necrotizing pancreatitis.
Detailed Description
Acute pancreatitis has an annual incidence of 13-45 cases per 100,000 persons and is one of the most common gastrointestinal disorders requiring hospitalization worldwide. It leads to over a quarter of a million hospital admissions annually in the United States, and inpatient costs exceeding 2.5 billion US dollars. Pancreatic necrosis occurs as a consequence of severe acute pancreatitis in approximately 20% of patients. It can mature into a contained necrotic collection, typically four weeks into the disease course. With intense conservative management, including nutritional and intensive care support when required, the collection may resolve without intervention. However, a persistent collection with pain, gastric outlet, intestinal or biliary obstruction, new-onset or persisting organ failure, persistent unwellness or infection is associated with a mortality of 15-20%, and requires necrosectomy and drainage. Without intervention, infected necrosis ultimately leads to death in nearly every patient.
Recently, there has been a shift away from surgical debridement (necrosectomy) towards minimally-invasive endoscopic methods in the treatment of necrotizing pancreatitis. Endoscopic management involves creation of a fistula between the enteric wall and necrotic collection under the guidance of endoscopic ultrasound [EUS] with subsequent placement of a stent to allow drainage of the necrotic material. Endoscopic transenteral drainage of necrotic collection is associated with favorable outcomes, with treatment success rates reported in the range of 45-70%. Endoscopic necrosectomy, with the additional technique of extraction of necrotic material under direct endoscopic visualization has increased rates of treatment success to greater than 80%.
However, there are currently scant data on the optimal timing of endoscopic necrosectomy. In a retrospective study, performing endoscopic necrosectomy at the time of the initial EUS-guided drainage of the necrotic collection was associated with a significantly lower number of necrosectomy sessions compared to performing endoscopic necrosectomy one week after drainage.
The aim of this randomized trial is to compare clinical outcomes between patients undergoing immediate endoscopic necrosectomy (direct endoscopic necrosectomy) compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for infected necrotizing pancreatitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Necrosis, Necrosis Pancreas
Keywords
pancreatic necrosis, pancreatic necrotic collection, transenteric drainage, necrosectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
During follow up, the coordinators that are contacting the subjects will be blinded to the randomization assignment.
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Direct Endoscopic Necrosectomy
Arm Type
Active Comparator
Arm Description
The subject will have endoscopic drainage and necrosectomy at the time of the index intervention.
Arm Title
Step-up Endoscopic Interventions
Arm Type
Active Comparator
Arm Description
The subject will only have endoscopic drainage of the pancreatic necrotic collection at the time of index intervention.
Intervention Type
Procedure
Intervention Name(s)
Direct Endoscopic Intervention
Intervention Description
The necrotic collection is first identified using a linear echoendoscope. A Hot AXIOS stent is utilized in all patients for EUS-guided drainage of the necrotic collection. The necrotic material is sent for gram stain and culture with sensitivities.
For endoscopic necrosectomy, in patients allocated to direct endoscopic necrosectomy group, endoscopic necrosectomy is performed during the same session as the index endoscopic drainage. It is performed using a therapeutic gastroscope and various accessories (see below for further details) for 90 to 120 minutes.
Intervention Type
Procedure
Intervention Name(s)
Step-up Endoscopic Intervention
Intervention Description
The necrotic collection is first identified using a linear echoendoscope. A Hot AXIOS stent is utilized in all patients for EUS-guided drainage of the necrotic collection. The necrotic material is sent for gram stain and culture with sensitivities.
In patients allocated to the step-up endoscopic interventions group, endoscopic necrosectomy is not performed at the time of the index intervention, however it is performed when clinically indicated during the follow-up period (6 months from index intervention).
Primary Outcome Measure Information:
Title
Rate of treatment success
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rate of resolution of pre-intervention systemic inflammatory response syndrome
Description
Assessment of preintervention systemic inflammatory response syndrome & their resolution and measured by yes/no.
Time Frame
72 hours post index procedure
Title
Rate of resolution of at least 1 pre-intervention organ failure
Description
Assessment of organ failure following the index procedure and their resolution and measured by yes/no.
Time Frame
72 hours post index procedure
Title
Number of re-admissions
Description
Assessing the total number of re-admissions following the index procedure.
Time Frame
6 months
Title
Rate of technical success for EUS-guided cystogastrostomy
Description
Technical success for EUS-guided cystogastrostomy defined as completion of endoscopic necrosectomy session as planned without the occurrence of adverse events and measured by yes/no.
Time Frame
24 hours
Title
Rate of technical success for endoscopic necrosectomy
Description
Technical success for endoscopic necrosectomy defined as any adverse event occurring as a result of necrotizing pancreatitis and measured by yes/no.
Time Frame
6 months
Title
Rate of exocrine pancreatic insufficiency
Description
Rate of exocrine pancreatic insufficiency defined as fecal elastase level < 200μg/g in patients not previously taking pancreatic enzyme supplements
Time Frame
6 months
Title
Rate of new onset diabetes
Description
Rate of new onset diabetes 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%
Time Frame
6 months
Title
Number of Procedure-related adverse events
Description
Procedure-related adverse events defined as any adverse event occurring as a result of any endoscopic intervention. The subject will be asked to report and medical records will be reviewed for any adverse events related to the procedure.
Time Frame
6 months
Title
Number of Disease-related adverse events
Description
Disease-related adverse events, defined as any adverse event occurring as a result of necrotizing pancreatitis. The subject will be asked to report and medical records will be reviewed for any adverse events related to the procedure.
Time Frame
6 months
Title
Post-procedure length of intensive care unit (ICU) stay
Description
Measured in the number of days in the intensive care unit
Time Frame
6 months
Title
Total length of hospital stay
Description
Measured in the number of days in the hospital
Time Frame
6 months
Title
Overall treatment costs
Description
Overall treatment costs from admission until 6 months post index intervention. All relevant costs pertaining to treatment will be taken into consideration - procedure costs, inpatient hospital stay from date of procedure to discharge, readmissions, medications, materials, anesthesia, pharmacy and imaging studies.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements
The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures
Males or females ≥ 18 years of age
Necrotic collection 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 ≥ 33% of solid/necrotic component and any no. of loculations, located within the pancreatic/peri-pancreatic space
Necrotic collection visualized on EUS and amenable to EUS-guided drainage
Suspected/confirmed infected necrotic collection. Infected necrosis is defined by the presence of gas in the necrotic collection on cross-sectional imaging or positive culture of necrotic tissue obtained preprocedure or at first intervention. Infected necrosis is also suspected when sepsis is persistent or in the presence of ongoing clinical deterioration.
Documented history of acute pancreatitis Acute pancreatitis is diagnosed if 2 of the following 3 criteria are met
Abdominal pain characteristic of acute pancreatitis
Serum lipase/amylase ≥ x3 upper limit of normal
Characteristic radiological findings of acute pancreatitis on CECT/MRI/US abdomen, such as homogeneous enhancement of pancreatic parenchyma, standing of peripancreatic fat
Able to undergo general anesthesia
Exclusion Criteria:
Females who are pregnant or lactating. Pregnancy for females of childbearing potential will be determined by routine preoperative urine or serum HCG testing.
Irreversible coagulopathy (INR >1.5, thrombocytopenia with platelet count <50,000/mL)
Has surgically altered gastrointestinal anatomy such as but not limited to Billroth II, Roux-en-Y, gastric bypass
Age < 18 years
Unable to obtain consent for the procedure from either the patient or LAR
Use of anticoagulants that cannot be discontinued for the procedure
Unable to tolerate general anesthesia
Necrotic collection that is not accessible for EUS-guided drainage
Percutaneous drainage of the necrotic collection is required or performed prior to EUS-guided drainage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Hasan, MD
Organizational Affiliation
AdventHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Interventional Endoscopy
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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23622135
Citation
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Endoscopic Necrosectomy Versus Step-up Endoscopic Intervention
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