Pancreatitis,Acute NecrotizingNCT04057846
Lumen Apposing Metal Stents vs Double Pigtail Stents
A study testing EUS guided transgastric drainage in people with Pancreatitis,Acute Necrotizing, run by John Gasdal Karstensen at 1 site in Denmark.
Trial summary
While the majority of 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis,Acute Necrotizing
- What is being tested?
- EUS guided transgastric drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Aug 2019to 31 May 2022
- 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
- Patients with acute, necrotizing pancreatitis and
- WON exceeding a diameter of 15 cm (measured on contrast-enhanced CT (CECT); see details on imaging tests below). WON is defined based on the revised Atlanta criteria as a mature, encapsulated pancreatic or peripancreatic necrosis with a well-defined inflammatory wall[12].
- 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:
- 1. Confirmed or suspected infection.1 2. Severe intraabdominal hypertension or abdominal compartment syndrome. 3. Persisting abdominal pain, early satiety, or general discomfort. 4. Obstruction of the GI or biliary tract. 5. Leakage of pancreatic juice, e.g. ascites or pleural effusion.
Show all 10Show fewer
- 3. Preoperatively, the WON must be considered eligible for endoscopic, transgastric drainage with both conventional double pigtail and LAMS technique. Distance between the gastric wall and WON must not exceed one cm and there must be no major interposed vessels.
- Infection in WON:
- Confirmed infected necrosis is defined as a) positive culture from WON obtained by fine- needle aspiration prior to or at the first drainage procedure or b) presence of gas in WON on CECT prior to drainage with no earlier puncture/drainage and no signs of perforation to the GI tract.
- Infected necrosis is suspected when a patient with WON present with clinical signs of persistent sepsis without other causes of infection.
Who cannot join
- Patients under the age of 18.
- Pregnancy.
- Known or suspected malignant disease.
- Pancreatitis secondary to trauma or surgical intervention.
- Chronic pancreatitis.
- Collections that may only be drained from the duodenum.
- Previous surgical or endoscopic drainage or necrosectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EUS-guided Drainage of Large Walled-off Pancreatic Necrosis Using Lumen Apposing Metal Stents or Standard Double Pigtail Technique. A Single-center, Open-label, Randomized, Superiority Trial
While the majority of 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 (WON). Up to 30% of WONs become infected, which prolongs the length of hospital stay, increases morbidity and mortality significantly, and generally requires an invasive intervention. During the last decade, minimally invasive therapies consisting of percutaneous and endoscopic, transluminal drainage followed, if necessary, by percutaneous or endoscopic necrosectomy, have replaced open surgery as the standard treatment resulting in better patient outcomes. The investigators have for nearly two decades been practicing an endoscopic step-up approach as standard treatment for infected WON.
Recently, lumen apposing metal stents (LAMS) have been introduced for the 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 electro cautery device enables extra-luminal access and deployment of the stent. Initial results from primarily retrospective case series were promising. However, a recent randomized controlled trial failed to demonstrate superiority in terms of number of necrosectomies needed, treatment success, clinical adverse events, readmissions, length of hospital stay (LOS), and overall treatment costs. Furthermore, a number of serious adverse events with development of pseudoaneurisms probably due to collapse of the cavity have led to alterations in treatment with sequential computed tomography (CT) scans and insertion of double pigtail stents within the metal stent. In that trial, the mean diameter of the treated necroses was limited and in addition, the study was launched before the introduction of a novel 20 mm in diameter LAMS. The investigators hypothesize, that use of a 20 mm LAMS in large caliber WON is superior to the standard double pigtail technique.
Aim To compare the use of a novel 20 mm lumen apposing metal stent (LAMS) (Hot Axios, Boston Scientific) with a conventional double pigtail technique for endoscopic transluminal drainage of large (> 15 cm) pancreatic and/or peripancreatic walled-of necrosis (WON).
- Conditions
- Pancreatitis,Acute Necrotizing
- Being tested
- EUS guided transgastric drainage
- Keywords
- Walled of necrosis, Endoscopic drainage, Lumen apposing metal stents
- 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.
EUS guided transgastric drainageDevice
Whenever possible, randomisation and intervention shall be postponed until 4 weeks after onset of pancreatitis in line with international guidelines. All procedures in this study shall be performed by three experienced endoscopists (PNS, EFH, SN), who all have an extensive experience in endoscopic ultrasound (EUS-) guided drainage of pancreatic collections and the use of self-expanding stents. They have together performed more than 300 endoscopic, transmural drainage and debridement procedures in patients with WON since 2005. Endosonography-guided, transgastric drainage of the WONs shall be performed using a curve-linear echoendoscope (endoscope: Olympus GF-UCT180; ultrasound scanner: Hitachi Arietta 850 or Olympus EU-ME2). All collections shall be treated by single tract transmural cystogastrostomy (single-gate technique). T
| Study group | Role | What they receive |
|---|---|---|
| Double pigtail | Active comparator | Plastic stent group EUS-guided drainage shall be performed as follows: a) Puncture of WON with a 19 GA Access needle (Cook Medical), b) aspiration of fluid in WON for microbiological assessment, c) insertion of guidewire (0.035 inch, 450 cm, Dreamwire (Boston Scientific), d) creation of transmural tract with needle knife over the guidewire, e) dilatation of tract to a diameter of 15 mm with dilation balloon (EZDilate, Olympus), f) insertion of two 7-Fr/6 cm double pigtail stents and a 7-Fr naso-cystic irrigation catheter. Receives: Device: EUS guided transgastric drainage |
| Lumen apposing metal stent | Experimental | LAMS shall be the Hot AXIOS stent with electrocautery-enhanced delivery system (Boston Scientific). The stent is a through-the-scope, fully covered, self-expandable metal stents with a diameter of 20 mm and a length of 10 mm. Before placement of the LAMS, the WON shall be punctured with a 19 GA Access needle (Cook Medical) and fluid in WON aspirated for microbiological assessment. Thereafter the LAMS shall be placed as follows: After directly puncturing the WON using the electrocautery tip (without the use of a guidewire to assist in stent insertion), the delivery catheter is advanced into the WON and the distal flange is deployed under EUS-guidance. The proximal flange is then released under EUS guidance or endoscopic view. After placement of the LAMS, a 7-Fr/4cm double pigtail and a 7-Fr nasocystic irrigation catheter shall be placed through the LAMS. Receives: Device: EUS guided transgastric drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of necrosectomies
Number of debridement procedures (endoscopic and video-assisted) needed throughout the disease course.
Measured: Through study completion, an average of 2 year
Secondary outcomes (15)
Number of endoscopic procedures
Number of endoscopic procedures (drainage (including redilatation) and debridement)
Measured: Through study completion, an average of 6 months
Total number of drainage and debridement procedures (radiological, endoscopic, and surgical)
Measured: Through study completion, an average of 6 months
Number of days from index drainage procedure until removal of naso-cystic catheter
Measured: Through study completion, an average of 6 months
Duration of drainage and debridement procedures
Duration of drainage and debridement procedures (index and cumulated). It will be in minutes
Measured: Through study completion, an average of 6 months
Length of hospital stay from the index drainage procedure
Days of hospital stay from the index drainage procedure
Measured: Through study completion, an average of 6 months
Length of ICU stay
Days in the ICU
Measured: Through study completion, an average of 6 months
Resolution of pre-interventional systemic inflammatory response syndrome (SIRS) (sepsis)
Restoration of normal blood pressure, temperature, heart rate, inspiratory rate, and white blod cell count
Measured: Through study completion, an average of 6 months
New onset episodes of culture verified bacteremia
Measured: Through study completion, an average of 6 months
Occurrence of splanchnic vein thrombosis (portal-, splenic-, or superior mesenteric vein)
Measured: Through study completion, an average of 6 months
Need for tube feeding (naso-gastric or naso-jejunal) or parenteral nutrition
Measured: Through study completion, an average of 6 months
CRP-area under curve (AUC) from the index drainage procedure until discharge from hospital
Measured: Though the hospital stay, an average of 6 months
Number of adverse events according to the ASGE lexicon and Clavien-Dindo.
Specific adverse events and grouped by severity
Measured: Though the hospital stay, an average of 6 months
Mortality
The rate mortality compared between the two study groups
Measured: Though the hospital stay, an average of 6 months
Exocrine and endocrine insufficiency
The unset of diabetes and Steatorré
Measured: Though the hospital stay, an average of 6 months
Total treatment costs.
In euros and dollars
Measured: Through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start29 Aug 2019
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis,Acute NecrotizingStudies 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
- A single-center, open-label, randomized, superiority trial
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Gasdal Karstensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Gasdal Karstensen, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057846
- Sponsor's protocol ID
- LAMS vs DPT
- Status last verified
- Aug 2022
- First submitted
- 29 Jul 2019
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
van Dijk SM, Hallensleben NDL, van Santvoort HC, Fockens P, van Goor H, Bruno MJ, Besselink MG; Dutch Pancreatitis Study Group. Acute pancreatitis: recent advances through randomised trials. Gut. 2017 Nov;66(11):2024-2032. doi: 10.1136/gutjnl-2016-313595. Epub 2017 Aug 24.
PubMed 28838972Banks 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 17032204Yan 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.
PubMed 29882517Schmidt PN, Novovic S, Roug S, Feldager E. Endoscopic, transmural drainage and necrosectomy for walled-off pancreatic and peripancreatic necrosis is associated with low mortality--a single-center experience. Scand J Gastroenterol. 2015 May;50(5):611-8. doi: 10.3109/00365521.2014.946078. Epub 2015 Feb 3.
PubMed 25648776Bang 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.
PubMed 29858393Kovacevic B, Vilmann P, Karstensen JG. Endoscopic Ultrasonography-Guided Gastrojejunostomies With Lumen-Apposing Metal Stents. Clin Gastroenterol Hepatol. 2017 Mar;15(3):459-460. doi: 10.1016/j.cgh.2016.09.144. Epub 2016 Sep 28. No abstract available.
PubMed 27693524Karstensen JG, Novovic S, Hansen EF, Jensen AB, Jorgensen HL, Lauritsen ML, Werge MP, Schmidt PN. EUS-guided drainage of large walled-off pancreatic necroses using plastic versus lumen-apposing metal stents: a single-centre randomised controlled trial. Gut. 2023 Jun;72(6):1167-1173. doi: 10.1136/gutjnl-2022-328225. Epub 2022 Nov 29.
PubMed 36446550
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided Drainage of Large Walled-off Pancreatic Necrosis Using Lumen Apposing Metal Stents or Standard Double Pigtail Technique. A Single-center, Open-label, Randomized, Superiority Trial
- ClinicalTrials.gov ID
- NCT04057846
- Acronym / sponsor ID
- LAMS vs DPT
- Conditions
- Pancreatitis,Acute Necrotizing
- Keywords
- Walled of necrosis, Endoscopic drainage, Lumen apposing metal stents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- John Gasdal KarstensenUniversity, hospital or other
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 15 Aug 2019 (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.
While the majority of 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 (WON). Up to 30% of WONs become infected, which prolongs the length of hospital stay, increases morbidity and mortality significantly, and generally requires an invasive intervention. During the last decade, minimally invasive therapies consisting of percutaneous and endoscopic, transluminal drainage followed, if necessary, by percutaneous or endoscopic necrosectomy, have replaced open surgery as the standard treatment resulting in better patient outcomes. The investigators have for nearly two decades been practicing an endoscopic step-up approach as standard treatment for infected WON.
Recently, lumen apposing metal stents (LAMS) have been introduced for the 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 electro cautery device enables extra-luminal access and deployment of the stent. Initial results from primarily retrospective case series were promising. However, a recent randomized controlled trial failed to demonstrate superiority in terms of number of necrosectomies needed, treatment success, clinical adverse events, readmissions, length of hospital stay (LOS), and overall treatment costs. Furthermore, a number of serious adverse events with development of pseudoaneurisms probably due to collapse of the cavity have led to alterations in treatment with sequential computed tomography (CT) scans and insertion of double pigtail stents within the metal stent. In that trial, the mean diameter of the treated necroses was limited and in addition, the study was launched before the introduction of a novel 20 mm in diameter LAMS. The investigators hypothesize, that use of a 20 mm LAMS in large caliber WON is superior to the standard double pigtail technique.
Aim To compare the use of a novel 20 mm lumen apposing metal stent (LAMS) (Hot Axios, Boston Scientific) with a conventional double pigtail technique for endoscopic transluminal drainage of large (> 15 cm) pancreatic and/or peripancreatic walled-of necrosis (WON).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single-center, open-label, randomized, superiority trial
| Arm | Type | Receives |
|---|---|---|
| Double pigtail | Active comparator | Device: EUS guided transgastric drainagePlastic stent group EUS-guided drainage shall be performed as follows: a) Puncture of WON with a 19 GA Access needle (Cook Medical), b) aspiration of fluid in WON for microbiological assessment, c) insertion of guidewire (0.035 inch, 450 cm, Dreamwire (Boston Scientific), d) creation of transmural tract with needle knife over the guidewire, e) dilatation of tract to a diameter of 15 mm with dilation balloon (EZDilate, Olympus), f) insertion of two 7-Fr/6 cm double pigtail stents and a 7-Fr naso-cystic irrigation catheter. |
| Lumen apposing metal stent | Experimental | Device: EUS guided transgastric drainageLAMS shall be the Hot AXIOS stent with electrocautery-enhanced delivery system (Boston Scientific). The stent is a through-the-scope, fully covered, self-expandable metal stents with a diameter of 20 mm and a length of 10 mm. Before placement of the LAMS, the WON shall be punctured with a 19 GA Access needle (Cook Medical) and fluid in WON aspirated for microbiological assessment. Thereafter the LAMS shall be placed as follows: After directly puncturing the WON using the electrocautery tip (without the use of a guidewire to assist in stent insertion), the delivery catheter is advanced into the WON and the distal flange is deployed under EUS-guidance. The proximal flange is then released under EUS guidance or endoscopic view. After placement of the LAMS, a 7-Fr/4cm double pigtail and a 7-Fr nasocystic irrigation catheter shall be placed through the LAMS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with acute, necrotizing pancreatitis and
- One or more indication(s) for endoscopic, transmural drainage must be established:
- 1. Confirmed or suspected infection.1 2. Severe intraabdominal hypertension or abdominal compartment syndrome. 3. Persisting abdominal pain, early satiety, or general discomfort. 4. Obstruction of the GI or biliary tract. 5. Leakage of pancreatic juice, e.g. ascites or pleural effusion.
- 3. Preoperatively, the WON must be considered eligible for endoscopic, transgastric drainage with both conventional double pigtail and LAMS technique. Distance between the gastric wall and WON must not exceed one cm and there must be no major interposed vessels.
- Confirmed infected necrosis is defined as a) positive culture from WON obtained by fine- needle aspiration prior to or at the first drainage procedure or b) presence of gas in WON on CECT prior to drainage with no earlier puncture/drainage and no signs of perforation to the GI tract.
Key exclusion criteria (7 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 |
|---|---|---|
| EUS guided transgastric drainageWhenever possible, randomisation and intervention shall be postponed until 4 weeks after onset of pancreatitis in line with international guidelines. All procedures in this study shall be performed by three experienced endoscopists (PNS, EFH, SN), who all have an extensive experience in endoscopic ultrasound (EUS-) guided drainage of pancreatic collections and the use of self-expanding stents. They have together performed more than 300 endoscopic, transmural drainage and debridement procedures in patients with WON since 2005. Endosonography-guided, transgastric drainage of the WONs shall be performed using a curve-linear echoendoscope (endoscope: Olympus GF-UCT180; ultrasound scanner: Hitachi Arietta 850 or Olympus EU-ME2). All collections shall be treated by single tract transmural cystogastrostomy (single-gate technique). T | Device | Double pigtail, Lumen apposing metal stent |
Primary outcome
Number of necrosectomies
Time frame: Through study completion, an average of 2 year
Number of debridement procedures (endoscopic and video-assisted) needed throughout the disease course.
15 secondary outcomes
Number of endoscopic procedures
Time frame: Through study completion, an average of 6 months
Total number of drainage and debridement procedures (radiological, endoscopic, and surgical)
Time frame: Through study completion, an average of 6 months
Number of days from index drainage procedure until removal of naso-cystic catheter
Time frame: Through study completion, an average of 6 months
Duration of drainage and debridement procedures
Time frame: Through study completion, an average of 6 months
Length of hospital stay from the index drainage procedure
Time frame: Through study completion, an average of 6 months
Length of ICU stay
Time frame: Through study completion, an average of 6 months
Resolution of pre-interventional systemic inflammatory response syndrome (SIRS) (sepsis)
Time frame: Through study completion, an average of 6 months
New onset episodes of culture verified bacteremia
Time frame: Through study completion, an average of 6 months
Occurrence of splanchnic vein thrombosis (portal-, splenic-, or superior mesenteric vein)
Time frame: Through study completion, an average of 6 months
Need for tube feeding (naso-gastric or naso-jejunal) or parenteral nutrition
Time frame: Through study completion, an average of 6 months
CRP-area under curve (AUC) from the index drainage procedure until discharge from hospital
Time frame: Though the hospital stay, an average of 6 months
Number of adverse events according to the ASGE lexicon and Clavien-Dindo.
Time frame: Though the hospital stay, an average of 6 months
Mortality
Time frame: Though the hospital stay, an average of 6 months
Exocrine and endocrine insufficiency
Time frame: Though the hospital stay, an average of 6 months
Total treatment costs.
Time frame: Through study completion
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 2 Aug 2022.
- Background: PubMed 28838972van Dijk SM, Hallensleben NDL, van Santvoort HC, Fockens P, van Goor H, Bruno MJ, Besselink MG; Dutch Pancreatitis Study Group. Acute pancreatitis: recent advances through randomised trials. Gut. 2017 Nov;66(11):2024-2032. doi: 10.1136/gutjnl-2016-313595. Epub 2017 Aug 24.
- 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 29882517Yan 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.
- Background: PubMed 25648776Schmidt PN, Novovic S, Roug S, Feldager E. Endoscopic, transmural drainage and necrosectomy for walled-off pancreatic and peripancreatic necrosis is associated with low mortality--a single-center experience. Scand J Gastroenterol. 2015 May;50(5):611-8. doi: 10.3109/00365521.2014.946078. Epub 2015 Feb 3.
- Background: PubMed 29858393Bang 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.
- Background: PubMed 27693524Kovacevic B, Vilmann P, Karstensen JG. Endoscopic Ultrasonography-Guided Gastrojejunostomies With Lumen-Apposing Metal Stents. Clin Gastroenterol Hepatol. 2017 Mar;15(3):459-460. doi: 10.1016/j.cgh.2016.09.144. Epub 2016 Sep 28. No abstract available.
- Derived from this study: PubMed 36446550Karstensen JG, Novovic S, Hansen EF, Jensen AB, Jorgensen HL, Lauritsen ML, Werge MP, Schmidt PN. EUS-guided drainage of large walled-off pancreatic necroses using plastic versus lumen-apposing metal stents: a single-centre randomised controlled trial. Gut. 2023 Jun;72(6):1167-1173. doi: 10.1136/gutjnl-2022-328225. Epub 2022 Nov 29.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS guided transgastric drainage in people with Pancreatitis,Acute Necrotizing, run by John Gasdal Karstensen 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 10 inclusion and 7 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 2 Aug 2022. 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?
Number of necrosectomies (time frame: Through study completion, an average of 2 year). 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 NCT04057846, which also lists 7 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 2 Aug 2022.