Endoscopic Necrosectomy Versus Step-up Endoscopic Intervention

NCT04113499 | Completed DMC

• 1 other identifier: 1438851
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Necrosis; Necrosis Pancreas

Keywords

pancreatic necrosis; pancreatic necrotic collection; transenteric drainage; necrosectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Rate of resolution of pre-intervention systemic inflammatory response syndrome

  72 hours post index procedure

• Rate of resolution of at least 1 pre-intervention organ failure

  72 hours post index procedure

• Number of re-admissions

  6 months

• Rate of technical success for EUS-guided cystogastrostomy

  24 hours

• Rate of technical success for endoscopic necrosectomy

  6 months

Study Arms (2)

Direct Endoscopic Necrosectomy

ACTIVE COMPARATOR

The subject will have endoscopic drainage and necrosectomy at the time of the index intervention.

Procedure: Direct Endoscopic Intervention

Step-up Endoscopic Interventions

ACTIVE COMPARATOR

The subject will only have endoscopic drainage of the pancreatic necrotic collection at the time of index intervention.

Procedure: Step-up Endoscopic Intervention

Interventions

Direct Endoscopic Intervention PROCEDURE

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.

Direct Endoscopic Necrosectomy

Step-up Endoscopic Intervention PROCEDURE

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).

Step-up Endoscopic Interventions

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Center for Interventional Endoscopy

Orlando, Florida, 32803, United States

Location

Related Publications (12)

• Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.

  PMID: 23622135 BACKGROUND

• Peery AF, Dellon ES, Lund J, Crockett SD, McGowan CE, Bulsiewicz WJ, Gangarosa LM, Thiny MT, Stizenberg K, Morgan DR, Ringel Y, Kim HP, DiBonaventura MD, Carroll CF, Allen JK, Cook SF, Sandler RS, Kappelman MD, Shaheen NJ. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012 Nov;143(5):1179-1187.e3. doi: 10.1053/j.gastro.2012.08.002. Epub 2012 Aug 8.

  PMID: 22885331 BACKGROUND

• Beger HG, Rau B, Mayer J, Pralle U. Natural course of acute pancreatitis. World J Surg. 1997 Feb;21(2):130-5. doi: 10.1007/s002689900204.

  PMID: 8995067 BACKGROUND

• Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

  PMID: 23100216 BACKGROUND

• van Brunschot S, Bakker OJ, Besselink MG, Bollen TL, Fockens P, Gooszen HG, van Santvoort HC; Dutch Pancreatitis Study Group. Treatment of necrotizing pancreatitis. Clin Gastroenterol Hepatol. 2012 Nov;10(11):1190-201. doi: 10.1016/j.cgh.2012.05.005. Epub 2012 May 18.

  PMID: 22610008 BACKGROUND

• Bang JY, Arnoletti JP, Holt BA, Sutton B, Hasan MK, Navaneethan U, Feranec N, Wilcox CM, Tharian B, Hawes RH, Varadarajulu S. An Endoscopic Transluminal Approach, Compared With Minimally Invasive Surgery, Reduces Complications and Costs for Patients With Necrotizing Pancreatitis. Gastroenterology. 2019 Mar;156(4):1027-1040.e3. doi: 10.1053/j.gastro.2018.11.031. Epub 2018 Nov 16.

  PMID: 30452918 BACKGROUND

• Gardner TB, Chahal P, Papachristou GI, Vege SS, Petersen BT, Gostout CJ, Topazian MD, Takahashi N, Sarr MG, Baron TH. A comparison of direct endoscopic necrosectomy with transmural endoscopic drainage for the treatment of walled-off pancreatic necrosis. Gastrointest Endosc. 2009 May;69(6):1085-94. doi: 10.1016/j.gie.2008.06.061. Epub 2009 Feb 24.

  PMID: 19243764 BACKGROUND

• Varadarajulu S, Bang JY, Phadnis MA, Christein JD, Wilcox CM. Endoscopic transmural drainage of peripancreatic fluid collections: outcomes and predictors of treatment success in 211 consecutive patients. J Gastrointest Surg. 2011 Nov;15(11):2080-8. doi: 10.1007/s11605-011-1621-8. Epub 2011 Jul 23.

  PMID: 21786063 BACKGROUND

• Yan L, Dargan A, Nieto J, Shariaha RZ, Binmoeller KF, Adler DG, DeSimone M, Berzin T, Swahney M, Draganov PV, Yang DJ, Diehl DL, Wang L, Ghulab A, Butt N, Siddiqui AA. Direct endoscopic necrosectomy at the time of transmural stent placement results in earlier resolution of complex walled-off pancreatic necrosis: Results from a large multicenter United States trial. Endosc Ultrasound. 2019 May-Jun;8(3):172-179. doi: 10.4103/eus.eus_108_17.

  PMID: 29882517 BACKGROUND

• Bang JY, Navaneethan U, Hasan MK, Sutton B, Hawes R, Varadarajulu S. Non-superiority of lumen-apposing metal stents over plastic stents for drainage of walled-off necrosis in a randomised trial. Gut. 2019 Jul;68(7):1200-1209. doi: 10.1136/gutjnl-2017-315335. Epub 2018 Jun 1.

  PMID: 29858393 BACKGROUND

• Bang JY, Hasan MK, Navaneethan U, Sutton B, Frandah W, Siddique S, Hawes RH, Varadarajulu S. Lumen-apposing metal stents for drainage of pancreatic fluid collections: When and for whom? Dig Endosc. 2017 Jan;29(1):83-90. doi: 10.1111/den.12681. Epub 2016 Jun 15.

  PMID: 27199157 BACKGROUND

• 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

• Muhammad Hasan, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: During follow up, the coordinators that are contacting the subjects will be blinded to the randomization assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 2, 2019
• Study Start: November 27, 2019
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)