Endoscopic Step-up Approach Vs Aggressive Debridement of Large Pancreatic Walled-off Necrosis

NCT05601687 | Completed

• 1 other identifier: Accelerate
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare a conventional endoscopic step-up approach with an accelerated treatment algorithm using direct endoscopic necrosectomy in patients with acute necrotizing pancreatitis and walled of necroses exceeding a diameter of 15 cm. It will be investigated whether an aggressive treatment algorithm instead of a classical step-up approach will shorten the length of stay in the hospital and also reduce the mortality in patients treated for large walled off necroses.

Conditions

Pancreatic Necrosis; Pancreatitis, Acute Necrotizing

Keywords

Walled-off necrosis; Walled-off pancreatic necrosis; Endoscopic necrosectomy; Video-assisted retroperitoneal debridement

Outcome Measures

Primary Outcomes (1)

• A composite of major complications, death, or length of stay exceeding 58 days

  If patients either die, encounter a major complication, or stay in hospital for longer than 58 days, it will be registered as an event. Major complications are defined as new onset (i.e. not present 24 hours before randomization) organ failure (cardiovascular, pulmonary or renal), bleeding requiring intervention, perforation of a visceral organ requiring intervention, enterocutaneous fistula requiring intervention and incisional hernia (including burst abdomen).

  From date of randomization until discharge, assessed up to 12 months

Secondary Outcomes (17)

• Length of hospital stay from the index drainage procedure

  From date of randomization until discharge, assessed up to 12 months

• Total number of debridement procedures

  From date of randomization until discharge, assessed up to 12 months

• Total number of endoscopic procedures

  From date of randomization until discharge, assessed up to 12 months

• Total number of drainage and debridement procedures (radiological, endoscopic, and surgical)

  From date of randomization until discharge, assessed up to 12 months

• Number of days from index drainage procedure until removal of naso-cystic catheter

  From date of randomization until discharge, assessed up to 12 months

Study Arms (2)

Step-up Approach

ACTIVE COMPARATOR

Standard procedure where necrosectomy is only performed in the absence of clinical improvement 72 hours after placements of lumen-apposing metal stent.

Procedure: Step-up Approach

Direct Endoscopic Necrosectomy

EXPERIMENTAL

Necrosectomy will be performed in the same procedure as the placement of the lumen-apposing metal stent.

Procedure: Direct Endoscopic Necrosectomy

Interventions

Direct Endoscopic Necrosectomy PROCEDURE

Endosonography-guided, transmural drainage of the WONs shall be performed using a lumen-apposing metal stent (LAMS).After placement of the LAMS, EN shall be performed during the same procedure (Direct EN). After DEN, a 7-Fr/4cm double pigtail and a 7-Fr nasocystic irrigation catheter shall be placed through the LAMS. Endoscopic necrosectomy and VARD shall be repeated as often as clinically indicated and logistically possible with a minimum of one day between procedures

Direct Endoscopic Necrosectomy

Step-up Approach PROCEDURE

Endosonography-guided, transmural drainage of the WONs shall be performed using a lumen-apposing metal stent (LAMS). After placement of the LAMS, a 7-Fr/4cm double pigtail stent and a 7-Fr nasocystic catheter shall be placed through the LAMS. The effect of the index drainage procedure shall be evaluated every 72 hours and next treatment step will depend on whether the patient's condition improves. If clinical improvement is observed, the drainage regime continues, and no further therapeutic action shall be taken. In absence of clinical improvement after 72 hours and if supplementary drainage is impossible, the patient shall proceed to endoscopic necrosectomy (EN) or video-assisted retroperitoneal debridement (VARD). Absence of clinical improvement due to causes not related to the WON treatment, e.g., urinary tract or pulmonary infection or iv catheter sepsis, shall not influence the treatment algorithm of the WON.

Step-up Approach

Eligibility Criteria

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

You may qualify if:

• All criteria must be fulfilled
• Patients with acute, necrotizing pancreatitis and
• WON exceeding a diameter of 15 cm.
• Imaging test(s) must be done within 1 week before the index drainage procedure.
• Debut of pancreatitis must be within 3 months before the index drainage procedure.
• One or more indication(s) for endoscopic, transmural drainage must be established:
• Confirmed or suspected infection.
• Severe intraabdominal hypertension or abdominal compartment syndrome.
• Persisting abdominal pain, early satiety, or general discomfort.
• Obstruction of the GI or biliary tract.
• Leakage of pancreatic juice, e.g. pancreatic ascites or pleural effusion.
• Preoperatively, the WON must be considered eligible for endoscopic, transgastric drainage. Distance between the gastric wall and WON must not exceed one cm and there must be no major interposed vessels.

You may not qualify if:

• Patients under the age of 18.
• Pregnancy.
• Known or suspected malignant disease.
• Pancreatitis secondary to trauma or surgical intervention.
• Chronic pancreatitis.
• Previous surgical or endoscopic drainage or necrosectomy.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Copenhagen University Hospital, Hvidovre

Hvidovre, Denmark

Location

Related Publications (5)

• Ebrahim M, Werge MP, Hadi A, Lahchich M, Nagras ZG, Lauritsen ML, Schmidt PN, Hansen EF, Novovic S, Karstensen JG. Clinical outcomes following endoscopic or video-assisted retroperitoneal management of acute pancreatitis with large (>15 cm) walled-off pancreatic necrosis: Retrospective, single tertiary center cohort study. Dig Endosc. 2022 Sep;34(6):1245-1252. doi: 10.1111/den.14295. Epub 2022 Mar 29.

  PMID: 35258123 BACKGROUND

• Banks PA, Freeman ML; Practice Parameters Committee of the American College of Gastroenterology. Practice guidelines in acute pancreatitis. Am J Gastroenterol. 2006 Oct;101(10):2379-400. doi: 10.1111/j.1572-0241.2006.00856.x. No abstract available.

  PMID: 17032204 BACKGROUND

• van Brunschot S, van Grinsven J, Voermans RP, Bakker OJ, Besselink MG, Boermeester MA, Bollen TL, Bosscha K, Bouwense SA, Bruno MJ, Cappendijk VC, Consten EC, Dejong CH, Dijkgraaf MG, van Eijck CH, Erkelens GW, van Goor H, Hadithi M, Haveman JW, Hofker SH, Jansen JJ, Lameris JS, van Lienden KP, Manusama ER, Meijssen MA, Mulder CJ, Nieuwenhuis VB, Poley JW, de Ridder RJ, Rosman C, Schaapherder AF, Scheepers JJ, Schoon EJ, Seerden T, Spanier BW, Straathof JW, Timmer R, Venneman NG, Vleggaar FP, Witteman BJ, Gooszen HG, van Santvoort HC, Fockens P; Dutch Pancreatitis Study Group. Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected necrotising pancreatitis (TENSION trial): design and rationale of a randomised controlled multicenter trial [ISRCTN09186711]. BMC Gastroenterol. 2013 Nov 25;13:161. doi: 10.1186/1471-230X-13-161.

  PMID: 24274589 BACKGROUND

• Seewald S, Groth S, Omar S, Imazu H, Seitz U, de Weerth A, Soetikno R, Zhong Y, Sriram PV, Ponnudurai R, Sikka S, Thonke F, Soehendra N. Aggressive endoscopic therapy for pancreatic necrosis and pancreatic abscess: a new safe and effective treatment algorithm (videos). Gastrointest Endosc. 2005 Jul;62(1):92-100. doi: 10.1016/s0016-5107(05)00541-9.

  PMID: 15990825 BACKGROUND

• Olsen GA, Schmidt PN, Hadi A, Prahm AP, Werge MP, Roug S, Schefte DF, Lauritsen ML, Hansen EF, Novovic S, Karstensen JG. Accelerated vs Step-Up Endoscopic Treatment for Pancreatic Walled-Off Necrosis: A Randomized Controlled Trial (ACCELERATE). Clin Gastroenterol Hepatol. 2025 Aug 18:S1542-3565(25)00701-3. doi: 10.1016/j.cgh.2025.08.007. Online ahead of print.

  PMID: 40835042 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Study Officials

• John G Karstensen, MD Ph.d.

  Pancreatitis Centre East (PACE), Gastro Unit, Copenhagen University Hospital Hvidovre, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, MD

Model Details: Patients shall be randomly assigned in a 1:1 ratio to either the step-up or the accelerated approach. Block randomization shall be performed with a concealed, fixed block size using a web-based randomization program. Random block sizes of 4 or 6 shall be used for preparation of the randomization sequence. The computer-generated block randomization assignments shall be placed in opaque sealed envelopes. Randomization shall be performed by a study coordinator when patients meet the inclusion criteria.

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 1, 2022
• Study Start: November 1, 2022
• Primary Completion: September 15, 2024
• Study Completion: January 1, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: Sharing upon reasonable request

Locations

DK (1)