Endoscopic Necrosectomy Versus Step-up Endoscopic Intervention (DESTIN)

July 11, 2023 updated by: AdventHealth

A Randomized Trial Comparing Direct Endoscopic Necrosectomy vs. Step-up Transluminal Endoscopic Interventions in Infected Necrotizing Pancreatitis (DESTIN)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
        • Center for Interventional Endoscopy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements
  2. 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
  3. Males or females ≥ 18 years of age
  4. 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)
  5. Necrotic collection of any size with ≥ 33% of solid/necrotic component and any no. of loculations, located within the pancreatic/peri-pancreatic space
  6. Necrotic collection visualized on EUS and amenable to EUS-guided drainage
  7. 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.

  8. Documented history of acute pancreatitis Acute pancreatitis is diagnosed if 2 of the following 3 criteria are met

    1. Abdominal pain characteristic of acute pancreatitis
    2. Serum lipase/amylase ≥ x3 upper limit of normal
    3. Characteristic radiological findings of acute pancreatitis on CECT/MRI/US abdomen, such as homogeneous enhancement of pancreatic parenchyma, standing of peripancreatic fat
  9. Able to undergo general anesthesia

Exclusion Criteria:

  1. Females who are pregnant or lactating. Pregnancy for females of childbearing potential will be determined by routine preoperative urine or serum HCG testing.
  2. Irreversible coagulopathy (INR >1.5, thrombocytopenia with platelet count <50,000/mL)
  3. Has surgically altered gastrointestinal anatomy such as but not limited to Billroth II, Roux-en-Y, gastric bypass
  4. Age < 18 years
  5. Unable to obtain consent for the procedure from either the patient or LAR
  6. Use of anticoagulants that cannot be discontinued for the procedure
  7. Unable to tolerate general anesthesia
  8. Necrotic collection that is not accessible for EUS-guided drainage
  9. Percutaneous drainage of the necrotic collection is required or performed prior to EUS-guided drainage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Direct Endoscopic Necrosectomy
The subject will have endoscopic drainage and necrosectomy at the time of the index intervention.
Procedure: Direct Endoscopic Intervention

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.
Active Comparator: Step-up Endoscopic Interventions
The subject will only have endoscopic drainage of the pancreatic necrotic collection at the time of index intervention.
Procedure: Step-up Endoscopic Intervention

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of resolution of pre-intervention systemic inflammatory response syndrome
Time Frame: 72 hours post index procedure
Assessment of preintervention systemic inflammatory response syndrome & their resolution and measured by yes/no.
72 hours post index procedure
Rate of resolution of at least 1 pre-intervention organ failure
Time Frame: 72 hours post index procedure
Assessment of organ failure following the index procedure and their resolution and measured by yes/no.
72 hours post index procedure
Number of re-admissions
Time Frame: 6 months
Assessing the total number of re-admissions following the index procedure.
6 months
Rate of technical success for EUS-guided cystogastrostomy
Time Frame: 24 hours
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.
24 hours
Rate of technical success for endoscopic necrosectomy
Time Frame: 6 months
Technical success for endoscopic necrosectomy defined as any adverse event occurring as a result of necrotizing pancreatitis and measured by yes/no.
6 months
Rate of exocrine pancreatic insufficiency
Time Frame: 6 months
Rate of exocrine pancreatic insufficiency defined as fecal elastase level < 200μg/g in patients not previously taking pancreatic enzyme supplements
6 months
Rate of new onset diabetes
Time Frame: 6 months
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%
6 months
Number of Procedure-related adverse events
Time Frame: 6 months
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.
6 months
Number of Disease-related adverse events
Time Frame: 6 months
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.
6 months
Post-procedure length of intensive care unit (ICU) stay
Time Frame: 6 months
Measured in the number of days in the intensive care unit
6 months
Total length of hospital stay
Time Frame: 6 months
Measured in the number of days in the hospital
6 months
Overall treatment costs
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Investigators

  • Principal Investigator: Muhammad Hasan, MD, AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2019

Primary Completion (Actual)

April 25, 2022

Study Completion (Actual)

April 25, 2022

Study Registration Dates

First Submitted

October 1, 2019

First Submitted That Met QC Criteria

October 1, 2019

First Posted (Actual)

October 2, 2019

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1438851

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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