Randomized Trial of Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis

NCT05043415 | Unknown

• 2 other identifiers: 21.067.051746067
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized trial comparing immediate endoscopic necrosectomy vs. step-up endoscopic interventions in patients with necrotizing pancreatitis.

Conditions

Pancreatitis,Acute Necrotizing

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Secondary Outcomes (13)

• Rate of treatment success

  6 months

• Rate of resolution of pre-intervention systemic inflammatory response syndrome (SIRS)

  72 hours

• Rate of resolution of at least 1 pre-intervention organ failure at 72 hours post index intervention

  72 hours

• Total number of readmissions due to disease-related symptoms or procedure-related events

  6 months

• Rate of technical success for EUS-guided cystogastrostomy

  24 hours

Study Arms (2)

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

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.

Procedure: Step-up endoscopic interventions

Interventions

Immediate endoscopic necrosectomy PROCEDURE

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.

Immediate endoscopic necrosectomy

Step-up endoscopic interventions PROCEDURE

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.

Step-up endoscopic intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orlando Health, Inc.: lead
• Asian Institute of Gastroenterology, India: collaborator
• West Virginia University: collaborator
• University of Southern California: collaborator
• Marshall University: collaborator
• Mayo Clinic: collaborator
• University of Alabama at Birmingham: collaborator
• Rush University: collaborator

Study Sites (1)

Orlando Health

Orlando, Florida, 32806, United States

Location

Related Publications (1)

• 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.

  PMID: 37980922 DERIVED

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Ji Young Bang, MD MPH

  Orlando Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient undergoing procedure and research coordinator assessing outcome measures during follow-up will be blinded to the treatment group to which the patients are randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 14, 2021
• Study Start: August 18, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)