Pancreatic NecrosisNCT05601687
Endoscopic Step-up Approach vs Aggressive Debridement of Large Pancreatic Walled-off Necrosis
A study testing Direct Endoscopic Necrosectomy and Step-up Approach in people with Pancreatic Necrosis and Pancreatitis, Acute Necrotizing, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Necrosis, Pancreatitis, Acute Necrotizing
- What is being tested?
- Direct Endoscopic Necrosectomy and Step-up Approach
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Step-up Approach vs Aggressive Debridement of Large Pancreatic Walled-off Necrosis - A Single-center, Open-label, Randomized, Superiority Trial (ACCELERATE)
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.
Read the detailed description
INTRODUCTION While most patients with acute pancreatitis suffer a mild and uncomplicated course of disease, up to 20% develop a more severe course with development of pancreatic and/or peripancreatic necroses. With time, these necroses become encapsulated with a well-defined inflammatory wall, so called walled-off necroses (WONs). Up to 30% of WONs become infected, which prolongs the length of hospital stay (LOS), increases morbidity and mortality significantly, and generally requires some kind of invasive intervention. During the last two decades, a minimally invasive step-up approach consisting of percutaneous and/or endoscopic, transluminal drainage followed, if necessary, by percutaneous, video-assisted retroperitoneal debridement (VARD) or endoscopic necrosectomy (EN), have replaced open surgery as the standard treatment resulting in improved patient outcomes. Copenhagen University Hospital Hvidovre have for nearly two decades treated more than 400 WON patients with an actual annual number of 40-50 patients. This center serves as a tertiary referral center, the only in East-Denmark, with a background population of 2.6 million. In line with international guidelines, endoscopic step-up approach has been practiced as standard care for infected WONs. This approach follows international recommendations of delaying index procedures until at least four weeks after debut of pancreatitis (to ensure encapsulation) and then only applying the least invasive intervention needed. The decision to step-up is triggered by absence of biochemical and/or clinical improvement or clinical deterioration.
Recently, lumen-apposing metal stents (LAMS) have been introduced for the transluminal treatment of pancreatic fluid collections. The stent is fully-covered and shaped with two bilateral anchor flanges with a saddle in between. A dedicated through-the-scope delivery system, where the tip serves as an electrocautery device enables extra-luminal access and deployment of the stent. Conventionally, transmural drainage with installation of two double pigtail plastic stents (DPS) has been the method of choice. Although drainage with plastic stents seems non-inferior to LAMS, the DPS method implies a need for repetitive dilatation of the drainage tract because of spontaneous closure of the tract and thereby probably a higher number of endoscopic procedures. By keeping the transmural tract patent, LAMS may improve drainage and facilitate endoscopic necrosectomy, which may even be performed during the index procedure (direct endoscopic necrosectomy (DEN)).
The LOS is considerable for patients treated for infected WON, especially those with complex and large fluid collections. Copenhagen University Hvidovre Hospital has one of the largest prospective single center databases registering all patients treated with WON. The median LOS for patients with large WONs exceeding 15 cm in diameter treated with the step-up approach, is 58 days. During the hospital stay, patients undergo weekly endoscopic or surgical procedures, and many patients additionally need treatment in the intensive care unit. Together, the treatment of patients with WON carries a substantial economic burden for the health care system. Furthermore, even in a tertiary care setting, the mortality is still up to 15% in complex cases with large fluid collections. The mortality in patient needing treatment in intensive care unit (ICU) is much higher, nearly 40%. Unprotocolized cases with urgent needs for an augmented course of treatment (e.g. cases with malignancy demanding surgery or oncological therapy) have been successfully treated with an accelerated treatment algorithm. Likewise, an international multicenter study found that an aggressive treatment was safe with promising results. The invastegators hypothesize, that a general alteration in the treatment algorithm instigating an aggressive treatment algorithm instead of a classical step-up approach might not only shorten LOS, but also reduce the mortality in patients treated for large WONs.
AIM To compare a conventional endoscopic step-up approach with an accelerated treatment algorithm using DEN.
STUDY DESIGN A single-center open-label, randomized, controlled 2 armed superiority study.
Patients with acute, necrotizing pancreatitis and WON exceeding a diameter of 15 cm will be randomized to either the endoscopic step-up approach or direct endoscopic necrosectomy.
The primary endpoint is a composite of death, major complications occurring within 6 months following randomization, or length of stay exceeding 58 days.
From results previously published by Copenhagen University Hospital Hvidovre, it is shown that the risk of death for eligible patients is estimated to 5%, the risk of major complications is 5%, while the risk of exceeding a LOS of above 58 days is 50%. The investigators assume that the risk of death and major complications will remain at 5% and 5%, respectively, while the rate of patients exceeding a LOS of 58 days will be reduced by 75% to 12.5%. Based on these estimates, 48 patients are required to have an 80% change (5% significant level) of detecting an increase in success rate in the primary outcome measure from 40% in the control group to 77.5% in the interventional group.
The investigators will after inclusion of 25 patients conduct an interim analysis to assess whether one of the study groups are superior to an extent that will ethically call for an early termination of the study. Likewise, safety will continually be assessed in conjunction with the ethics committee.
- Being tested
- Direct Endoscopic Necrosectomy, Step-up Approach
- Keywords
- Walled-off necrosis, Walled-off pancreatic necrosis, Endoscopic necrosectomy, Video-assisted retroperitoneal debridement
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Endoscopic NecrosectomyProcedure or surgery
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
Step-up ApproachProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Direct Endoscopic Necrosectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From date of randomization until discharge, assessed up to 12 months
Secondary outcomes (17)
Length of hospital stay from the index drainage procedure
Measured: From date of randomization until discharge, assessed up to 12 months
Total number of debridement procedures
Number of endoscopic necrosectomies and video-assisted retroperitoneal debridements needed throughout the disease course.
Measured: From date of randomization until discharge, assessed up to 12 months
Total number of endoscopic procedures
Measured: From date of randomization until discharge, assessed up to 12 months
Total number of drainage and debridement procedures (radiological, endoscopic, and surgical)
Measured: From date of randomization until discharge, assessed up to 12 months
Number of days from index drainage procedure until removal of naso-cystic catheter
Measured: From date of randomization until discharge, assessed up to 12 months
Duration of drainage and debridement procedures (index and cumulated) measured in minutes
Measured: From date of randomization until discharge, assessed up to 12 months
Days at the hospital during a 6-month follow up
Measured: Assessed up to 12 months following randomization
Length of ICU stay
Days in the ICU during hospitalization
Measured: From date of randomization until discharge, assessed up to 12 months
Number of days until resolution of pre-interventional systemic inflammatory response syndrome (SIRS)
Number of days from randomization to restoration of normal blood pressure, temperature, heart rate, inspiratory rate, and white blood cell count
Measured: From date of randomization until discharge, assessed up to 12 months
New onset episodes of culture verified bacteremia
Measured: From date of randomization until discharge, assessed up to 12 months
Occurrence of splanchnic vein thrombosis (portal-, splenic-, or superior mesenteric vein)
Portal-, splenic-, or superior mesenteric vein thrombosis
Measured: From date of randomization until discharge, assessed up to 12 months
Need for tube feeding (naso-gastric or naso-jejunal) or parenteral nutrition
Measured: From date of randomization until discharge, assessed up to 12 months
CRP-area under curve
AUC from the index drainage procedure until discharge from hospital
Measured: From date of randomization until discharge, assessed up to 12 months
Number of adverse events
according to the ASGE lexicon and Clavien-Dindo
Measured: From date of randomization until discharge, assessed up to 12 months
Mortality
The rate mortality compared between the two study groups
Measured: From date of randomization until discharge, assessed up to 12 months
Unset of exocrine and endocrine insufficiency
The unset of diabetes and/or steatorrhea
Measured: From date of randomization until discharge, assessed up to 12 months
Total treatment costs.
In euros and dollars
Measured: From date of randomization until discharge, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Nov 2022
- Primary completion15 Sep 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gitte Aabye Olsen, MD, Copenhagen University Hospital, Hvidovre
- Investigators
- John G Karstensen, MD Ph.d., Study director, Pancreatitis Centre East (PACE), Gastro Unit, Copenhagen University Hospital Hvidovre, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601687
- Sponsor's protocol ID
- Accelerate
- Status last verified
- Feb 2025
- First submitted
- 21 Oct 2022
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing upon reasonable request
Publications
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.
PubMed 17032204van 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.
PubMed 24274589Seewald 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.
PubMed 15990825Ebrahim 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.
PubMed 35258123Olsen 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. 2026 Jun;24(6):1591-1600. doi: 10.1016/j.cgh.2025.08.007. Epub 2025 Aug 18.
PubMed 40835042
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Step-up Approach vs Aggressive Debridement of Large Pancreatic Walled-off Necrosis - A Single-center, Open-label, Randomized, Superiority Trial (ACCELERATE)
- ClinicalTrials.gov ID
- NCT05601687
- Acronym / sponsor ID
- Accelerate
- Keywords
- Walled-off necrosis, Walled-off pancreatic necrosis, Endoscopic necrosectomy, Video-assisted retroperitoneal debridement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
INTRODUCTION While most patients with acute pancreatitis suffer a mild and uncomplicated course of disease, up to 20% develop a more severe course with development of pancreatic and/or peripancreatic necroses. With time, these necroses become encapsulated with a well-defined inflammatory wall, so called walled-off necroses (WONs). Up to 30% of WONs become infected, which prolongs the length of hospital stay (LOS), increases morbidity and mortality significantly, and generally requires some kind of invasive intervention. During the last two decades, a minimally invasive step-up approach consisting of percutaneous and/or endoscopic, transluminal drainage followed, if necessary, by percutaneous, video-assisted retroperitoneal debridement (VARD) or endoscopic necrosectomy (EN), have replaced open surgery as the standard treatment resulting in improved patient outcomes. Copenhagen University Hospital Hvidovre have for nearly two decades treated more than 400 WON patients with an actual annual number of 40-50 patients. This center serves as a tertiary referral center, the only in East-Denmark, with a background population of 2.6 million. In line with international guidelines, endoscopic step-up approach has been practiced as standard care for infected WONs. This approach follows international recommendations of delaying index procedures until at least four weeks after debut of pancreatitis (to ensure encapsulation) and then only applying the least invasive intervention needed. The decision to step-up is triggered by absence of biochemical and/or clinical improvement or clinical deterioration.
Recently, lumen-apposing metal stents (LAMS) have been introduced for the transluminal treatment of pancreatic fluid collections. The stent is fully-covered and shaped with two bilateral anchor flanges with a saddle in between. A dedicated through-the-scope delivery system, where the tip serves as an electrocautery device enables extra-luminal access and deployment of the stent. Conventionally, transmural drainage with installation of two double pigtail plastic stents (DPS) has been the method of choice. Although drainage with plastic stents seems non-inferior to LAMS, the DPS method implies a need for repetitive dilatation of the drainage tract because of spontaneous closure of the tract and thereby probably a higher number of endoscopic procedures. By keeping the transmural tract patent, LAMS may improve drainage and facilitate endoscopic necrosectomy, which may even be performed during the index procedure (direct endoscopic necrosectomy (DEN)).
The LOS is considerable for patients treated for infected WON, especially those with complex and large fluid collections. Copenhagen University Hvidovre Hospital has one of the largest prospective single center databases registering all patients treated with WON. The median LOS for patients with large WONs exceeding 15 cm in diameter treated with the step-up approach, is 58 days. During the hospital stay, patients undergo weekly endoscopic or surgical procedures, and many patients additionally need treatment in the intensive care unit. Together, the treatment of patients with WON carries a substantial economic burden for the health care system. Furthermore, even in a tertiary care setting, the mortality is still up to 15% in complex cases with large fluid collections. The mortality in patient needing treatment in intensive care unit (ICU) is much higher, nearly 40%. Unprotocolized cases with urgent needs for an augmented course of treatment (e.g. cases with malignancy demanding surgery or oncological therapy) have been successfully treated with an accelerated treatment algorithm. Likewise, an international multicenter study found that an aggressive treatment was safe with promising results. The invastegators hypothesize, that a general alteration in the treatment algorithm instigating an aggressive treatment algorithm instead of a classical step-up approach might not only shorten LOS, but also reduce the mortality in patients treated for large WONs.
AIM To compare a conventional endoscopic step-up approach with an accelerated treatment algorithm using DEN.
STUDY DESIGN A single-center open-label, randomized, controlled 2 armed superiority study.
Patients with acute, necrotizing pancreatitis and WON exceeding a diameter of 15 cm will be randomized to either the endoscopic step-up approach or direct endoscopic necrosectomy.
The primary endpoint is a composite of death, major complications occurring within 6 months following randomization, or length of stay exceeding 58 days.
From results previously published by Copenhagen University Hospital Hvidovre, it is shown that the risk of death for eligible patients is estimated to 5%, the risk of major complications is 5%, while the risk of exceeding a LOS of above 58 days is 50%. The investigators assume that the risk of death and major complications will remain at 5% and 5%, respectively, while the rate of patients exceeding a LOS of 58 days will be reduced by 75% to 12.5%. Based on these estimates, 48 patients are required to have an 80% change (5% significant level) of detecting an increase in success rate in the primary outcome measure from 40% in the control group to 77.5% in the interventional group.
The investigators will after inclusion of 25 patients conduct an interim analysis to assess whether one of the study groups are superior to an extent that will ethically call for an early termination of the study. Likewise, safety will continually be assessed in conjunction with the ethics committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Step-up Approach | Active comparator | Procedure: Step-up ApproachStandard procedure where necrosectomy is only performed in the absence of clinical improvement 72 hours after placements of lumen-apposing metal stent. |
| Direct Endoscopic Necrosectomy | Experimental | Procedure: Direct Endoscopic NecrosectomyNecrosectomy will be performed in the same procedure as the placement of the lumen-apposing metal stent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- All criteria must be fulfilled
- Patients with acute, necrotizing pancreatitis and
- One or more indication(s) for endoscopic, transmural drainage must be established:
- 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.
Key exclusion criteria (6 listed)
- Patients under the age of 18.
- Pregnancy.
- Known or suspected malignant disease.
- Pancreatitis secondary to trauma or surgical intervention.
- Chronic pancreatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Endoscopic NecrosectomyEndosonography-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 | Procedure or surgery | Direct Endoscopic Necrosectomy |
| Step-up ApproachEndosonography-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. | Procedure or surgery | Step-up Approach |
Primary outcome
A composite of major complications, death, or length of stay exceeding 58 days
Time frame: From date of randomization until discharge, assessed up to 12 months
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).
17 secondary outcomes
Length of hospital stay from the index drainage procedure
Time frame: From date of randomization until discharge, assessed up to 12 months
Total number of debridement procedures
Time frame: From date of randomization until discharge, assessed up to 12 months
Total number of endoscopic procedures
Time frame: From date of randomization until discharge, assessed up to 12 months
Total number of drainage and debridement procedures (radiological, endoscopic, and surgical)
Time frame: From date of randomization until discharge, assessed up to 12 months
Number of days from index drainage procedure until removal of naso-cystic catheter
Time frame: From date of randomization until discharge, assessed up to 12 months
Duration of drainage and debridement procedures (index and cumulated) measured in minutes
Time frame: From date of randomization until discharge, assessed up to 12 months
Days at the hospital during a 6-month follow up
Time frame: Assessed up to 12 months following randomization
Length of ICU stay
Time frame: From date of randomization until discharge, assessed up to 12 months
Number of days until resolution of pre-interventional systemic inflammatory response syndrome (SIRS)
Time frame: From date of randomization until discharge, assessed up to 12 months
New onset episodes of culture verified bacteremia
Time frame: From date of randomization until discharge, assessed up to 12 months
Occurrence of splanchnic vein thrombosis (portal-, splenic-, or superior mesenteric vein)
Time frame: From date of randomization until discharge, assessed up to 12 months
Need for tube feeding (naso-gastric or naso-jejunal) or parenteral nutrition
Time frame: From date of randomization until discharge, assessed up to 12 months
CRP-area under curve
Time frame: From date of randomization until discharge, assessed up to 12 months
Number of adverse events
Time frame: From date of randomization until discharge, assessed up to 12 months
Mortality
Time frame: From date of randomization until discharge, assessed up to 12 months
Unset of exocrine and endocrine insufficiency
Time frame: From date of randomization until discharge, assessed up to 12 months
Total treatment costs.
Time frame: From date of randomization until discharge, assessed up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Background: PubMed 17032204Banks 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.
- Background: PubMed 24274589van 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.
- Background: PubMed 15990825Seewald 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.
- Results publication: PubMed 35258123Ebrahim 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.
- Derived from this study: PubMed 40835042Olsen 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. 2026 Jun;24(6):1591-1600. doi: 10.1016/j.cgh.2025.08.007. Epub 2025 Aug 18.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Sharing upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John G Karstensen, MD Ph.d. study director
Pancreatitis Centre East (PACE), Gastro Unit, Copenhagen University Hospital Hvidovre, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Endoscopic Necrosectomy and Step-up Approach in people with Pancreatic Necrosis and Pancreatitis, Acute Necrotizing, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of major complications, death, or length of stay exceeding 58 days (time frame: From date of randomization until discharge, assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05601687, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.