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Lumen Apposing Metal Stents vs Double Pigtail Stents

Primary Purpose

Pancreatitis,Acute Necrotizing

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
EUS guided transgastric drainage
Sponsored by
John Gasdal Karstensen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis,Acute Necrotizing focused on measuring Walled of necrosis, Endoscopic drainage, Lumen apposing metal stents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion criteria (all criteria must be fulfilled):

  1. Patients with acute, necrotizing pancreatitis and

    1. 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].
    2. Imaging test(s) must be done within 1 week before the index drainage procedure.
    3. Debut of pancreatitis must be within 3 months before the index drainage procedure.
  2. 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.

Infection in WON:

  1. 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.
  2. Infected necrosis is suspected when a patient with WON present with clinical signs of persistent sepsis without other causes of infection.

Exclusion Criteria:

  1. Patients under the age of 18.
  2. Pregnancy.
  3. Known or suspected malignant disease.
  4. Pancreatitis secondary to trauma or surgical intervention.
  5. Chronic pancreatitis.
  6. Collections that may only be drained from the duodenum.
  7. Previous surgical or endoscopic drainage or necrosectomy.

Sites / Locations

  • Copenhagen University Hospital Hvidovre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Double pigtail

Lumen apposing metal stent

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of necrosectomies
Number of debridement procedures (endoscopic and video-assisted) needed throughout the disease course.

Secondary Outcome Measures

Number of endoscopic procedures
Number of endoscopic procedures (drainage (including redilatation) and debridement)
Total number of drainage and debridement procedures (radiological, endoscopic, and surgical)
Number of days from index drainage procedure until removal of naso-cystic catheter
Duration of drainage and debridement procedures
Duration of drainage and debridement procedures (index and cumulated). It will be in minutes
Length of hospital stay from the index drainage procedure
Days of hospital stay from the index drainage procedure
Length of ICU stay
Days in the ICU
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
New onset episodes of culture verified bacteremia
Occurrence of splanchnic vein thrombosis (portal-, splenic-, or superior mesenteric vein)
Need for tube feeding (naso-gastric or naso-jejunal) or parenteral nutrition
CRP-area under curve (AUC) from the index drainage procedure until discharge from hospital
Number of adverse events according to the ASGE lexicon and Clavien-Dindo.
Specific adverse events and grouped by severity
Mortality
The rate mortality compared between the two study groups
Exocrine and endocrine insufficiency
The unset of diabetes and Steatorré
Total treatment costs.
In euros and dollars

Full Information

First Posted
July 29, 2019
Last Updated
August 1, 2022
Sponsor
John Gasdal Karstensen
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1. Study Identification

Unique Protocol Identification Number
NCT04057846
Brief Title
Lumen Apposing Metal Stents vs Double Pigtail Stents
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 29, 2019 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John Gasdal Karstensen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis,Acute Necrotizing
Keywords
Walled of necrosis, Endoscopic drainage, Lumen apposing metal stents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A single-center, open-label, randomized, superiority trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Double pigtail
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lumen apposing metal stent
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EUS guided transgastric drainage
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of necrosectomies
Description
Number of debridement procedures (endoscopic and video-assisted) needed throughout the disease course.
Time Frame
Through study completion, an average of 2 year
Secondary Outcome Measure Information:
Title
Number of endoscopic procedures
Description
Number of endoscopic procedures (drainage (including redilatation) and debridement)
Time Frame
Through study completion, an average of 6 months
Title
Total number of drainage and debridement procedures (radiological, endoscopic, and surgical)
Time Frame
Through study completion, an average of 6 months
Title
Number of days from index drainage procedure until removal of naso-cystic catheter
Time Frame
Through study completion, an average of 6 months
Title
Duration of drainage and debridement procedures
Description
Duration of drainage and debridement procedures (index and cumulated). It will be in minutes
Time Frame
Through study completion, an average of 6 months
Title
Length of hospital stay from the index drainage procedure
Description
Days of hospital stay from the index drainage procedure
Time Frame
Through study completion, an average of 6 months
Title
Length of ICU stay
Description
Days in the ICU
Time Frame
Through study completion, an average of 6 months
Title
Resolution of pre-interventional systemic inflammatory response syndrome (SIRS) (sepsis)
Description
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
Title
New onset episodes of culture verified bacteremia
Time Frame
Through study completion, an average of 6 months
Title
Occurrence of splanchnic vein thrombosis (portal-, splenic-, or superior mesenteric vein)
Time Frame
Through study completion, an average of 6 months
Title
Need for tube feeding (naso-gastric or naso-jejunal) or parenteral nutrition
Time Frame
Through study completion, an average of 6 months
Title
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
Title
Number of adverse events according to the ASGE lexicon and Clavien-Dindo.
Description
Specific adverse events and grouped by severity
Time Frame
Though the hospital stay, an average of 6 months
Title
Mortality
Description
The rate mortality compared between the two study groups
Time Frame
Though the hospital stay, an average of 6 months
Title
Exocrine and endocrine insufficiency
Description
The unset of diabetes and Steatorré
Time Frame
Though the hospital stay, an average of 6 months
Title
Total treatment costs.
Description
In euros and dollars
Time Frame
Through study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria (all criteria must be fulfilled): 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. 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Copenhagen University Hospital Hvidovre
City
Hvidovre
State/Province
Capital
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28838972
Citation
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.
Results Reference
background
PubMed Identifier
17032204
Citation
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.
Results Reference
background
PubMed Identifier
29882517
Citation
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.
Results Reference
background
PubMed Identifier
25648776
Citation
Schmidt 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. Erratum In: Scand J Gastroenterol. 2015 May;50(5):625.
Results Reference
background
PubMed Identifier
29858393
Citation
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.
Results Reference
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PubMed Identifier
27693524
Citation
Kovacevic 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.
Results Reference
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Lumen Apposing Metal Stents vs Double Pigtail Stents

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