An interventional study of EUS guided transgastric drainage in Pancreatitis,Acute Necrotizing, sponsored by John Gasdal Karstensen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by John Gasdal Karstensen · Not applicable, Interventional, and Treatment
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).
752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.
This study's enrollment of 42 is below the median of 80 across 448 interventional studies indexed under Pancreatitis.
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Inclusion criteria (all criteria must be fulfilled):
Patients with acute, necrotizing pancreatitis and
Infection in WON:
Exclusion Criteria:
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.
Device: EUS guided transgastric drainage
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.
Device: EUS guided transgastric drainage
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
Number of necrosectomies
Number of debridement procedures (endoscopic and video-assisted) needed throughout the disease course.
Time frame: Through study completion, an average of 2 year
Number of endoscopic procedures
Number of endoscopic procedures (drainage (including redilatation) and debridement)
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
Duration of drainage and debridement procedures (index and cumulated). It will be in minutes
Time frame: 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
Time frame: Through study completion, an average of 6 months
Length of ICU stay
Days in the ICU
Time frame: 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
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.
Specific adverse events and grouped by severity
Time frame: Though the hospital stay, an average of 6 months
Mortality
The rate mortality compared between the two study groups
Time frame: Though the hospital stay, an average of 6 months
Exocrine and endocrine insufficiency
The unset of diabetes and Steatorré
Time frame: Though the hospital stay, an average of 6 months
Total treatment costs.
In euros and dollars
Time frame: Through study completion
Plan to share: Undecided
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