Comparison of FCSEMS and Plastic Stents

Acute Pancreatic Fluid Collection Clinical Trial

— WON-MVP  

Official title:

Randomized Trial Comparing Fully Covered, Self-Expanding Metal Stent and Plastic Stents for Endoscopic Ultrasound-guided Drainage of Walled-off Necrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685865
• Other study ID #: 837579
• Status: Completed
• Phase: N/A
• Start date: February 12, 2016
• Est. completion date: August 2018

Study information

• Verified date: February 2019
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research design is a randomized prospective clinical trial comparing Endoscopic ultrasound (EUS) guided drainage of WON using FCSEMS and plastic stents. The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.

Description:

The research design is a randomized prospective clinical trial comparing EUS-guided drainage of WON using FCSEMS and plastic stents. The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.The sample size estimated for this study is 60 patients. All patients will undergo EUS-guided drainage of WON and be randomized to either FCSEM or plastic stents in a 1:1 ratio using a computer-generated randomized sequence. It will not be possible to blind the endoscopist to the stent type being inserted due to the differences in stent appearance. The statistician will be blinded to the stent type utilized.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.

2. The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.

3. Males or females = 18 years of age.

4. WON diagnosed on contrast-enhanced dual phase CT abdomen/pelvis (CECT) or MRI with gadolinium (seen as a fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a well-defined tissue layer).

5. WON of any size with any quantity of solid/necrotic component and any no. of loculations, located within the pancreatic/peri-pancreatic space not requiring percutaneous drainage, within 2cm of the enteric wall

6. Suspected/confirmed infected WON (defined as temp = 100.5°F, serum White Blood Cells = 15x109/L, positive blood cultures or positive Gram stain/culture of aspirated necrotic material), and/or symptomatic WON (defined as abdominal pain, gastric/intestinal/biliary outlet obstruction resulting in nausea, vomiting, early satiety, jaundice, or persistent malaise) = 4 weeks from attack of acute pancreatitis.

7. Documented history of acute or chronic pancreatitis:

i. Acute pancreatitis is diagnosed if 2 of the following 3 criteria are met:

1. Abdominal pain characteristic of acute pancreatitis

2. Serum lipase/amylase = x3 upper limit of normal

3. Characteristic radiological findings of acute pancreatitis on CECT/MRI/US abdomen, such as homogeneous enhancement of pancreatic parenchyma, standing of peripancreatic fat ii. Chronic pancreatitis is diagnosed if characteristic radiological changes are seen on CT/MRI with Magnetic resonance cholangiopancreatography (MRCP) (such as pancreatic atrophy, dilated pancreatic duct, pancreatic calcification) or EUS (=5/9 of Rosement criteria)

8. Able to undergo general anesthesia

Exclusion Criteria:

1. Females who are pregnant or lactating. Pregnancy for females of childbearing potential will be determined by routine preoperative urine or serum Human Chorionic Gonadotropin testing.

2. Irreversible coagulopathy (INR >1.5, thrombocytopenia with platelet count <50,000/mL)

3. Has surgically altered gastrointestinal anatomy such as but not limited to Billroth II, Roux-en-Y, gastric bypass

4. Age < 18 years

5. Unable to obtain consent for the procedure from either the patient or LAR

6. Use of anticoagulants that cannot be discontinued for the procedure

7. Unable to tolerate general anesthesia

8. WON that is not accessible for EUS-guided drainage

9. Percutaneous drainage of WON is required or performed prior to EUS-guided drainage

Related Conditions & MeSH terms

• Acute Pancreatic Fluid Collection
• Infected Pancreatic Necrosis
• Necrosis
• Pancreatic and Peripancreatic Necrosis
• Pancreatic Collection
• Symptomatic Pancreatic Necrosis

Intervention

Device:
• FCSEM Stent
Hot Axios Fully covered self-expandable metal stent - Boston Scientific
• Plastic Stent
7 French 4 cm double pigtail plastic stent - Cook 7 French 4 cm double pigtail plastic stent - Boston Scientific

Locations

Country	Name	City	State
United States	Center for Interventional Endoscopy - Florida Hospital Orlando	Orlando	Florida
United States	Florida Hospital Center for Interventional Endoscopy	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Hospital

Country where clinical trial is conducted

United States, 

References & Publications (13)

Bang JY, Holt BA, Hawes RH, Hasan MK, Arnoletti JP, Christein JD, Wilcox CM, Varadarajulu S. Outcomes after implementing a tailored endoscopic step-up approach to walled-off necrosis in acute pancreatitis. Br J Surg. 2014 Dec;101(13):1729-38. doi: 10.1002/bjs.9664. Epub 2014 Oct 21. — View Citation

Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25. — View Citation

Belle S, Collet P, Post S, Kaehler G. Temporary cystogastrostomy with self-expanding metallic stents for pancreatic necrosis. Endoscopy. 2010 Jun;42(6):493-5. doi: 10.1055/s-0029-1244021. Epub 2010 Apr 29. — View Citation

Berzosa M, Maheshwari S, Patel KK, Shaib YH. Single-step endoscopic ultrasonography-guided drainage of peripancreatic fluid collections with a single self-expandable metal stent and standard linear echoendoscope. Endoscopy. 2012 May;44(5):543-7. doi: 10.1055/s-0031-1291710. Epub 2012 Mar 9. — View Citation

Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. — View Citation

Forsmark CE. Management of chronic pancreatitis. Gastroenterology. 2013 Jun;144(6):1282-91.e3. doi: 10.1053/j.gastro.2013.02.008. Review. — View Citation

Gardner TB, Chahal P, Papachristou GI, Vege SS, Petersen BT, Gostout CJ, Topazian MD, Takahashi N, Sarr MG, Baron TH. A comparison of direct endoscopic necrosectomy with transmural endoscopic drainage for the treatment of walled-off pancreatic necrosis. Gastrointest Endosc. 2009 May;69(6):1085-94. doi: 10.1016/j.gie.2008.06.061. Epub 2009 Feb 24. — View Citation

Seifert H, Biermer M, Schmitt W, Jürgensen C, Will U, Gerlach R, Kreitmair C, Meining A, Wehrmann T, Rösch T. Transluminal endoscopic necrosectomy after acute pancreatitis: a multicentre study with long-term follow-up (the GEPARD Study). Gut. 2009 Sep;58(9):1260-6. doi: 10.1136/gut.2008.163733. Epub 2009 Mar 11. — View Citation

Stevens T. Update on the role of endoscopic ultrasound in chronic pancreatitis. Curr Gastroenterol Rep. 2011 Apr;13(2):117-22. doi: 10.1007/s11894-010-0167-3. Review. — View Citation

van Brunschot S, Bakker OJ, Besselink MG, Bollen TL, Fockens P, Gooszen HG, van Santvoort HC; Dutch Pancreatitis Study Group. Treatment of necrotizing pancreatitis. Clin Gastroenterol Hepatol. 2012 Nov;10(11):1190-201. doi: 10.1016/j.cgh.2012.05.005. Epub 2012 May 18. — View Citation

Varadarajulu S, Bang JY, Phadnis MA, Christein JD, Wilcox CM. Endoscopic transmural drainage of peripancreatic fluid collections: outcomes and predictors of treatment success in 211 consecutive patients. J Gastrointest Surg. 2011 Nov;15(11):2080-8. doi: 10.1007/s11605-011-1621-8. Epub 2011 Jul 23. — View Citation

Will U, Wanzar C, Gerlach R, Meyer F. Interventional ultrasound-guided procedures in pancreatic pseudocysts, abscesses and infected necroses - treatment algorithm in a large single-center study. Ultraschall Med. 2011 Apr;32(2):176-83. doi: 10.1055/s-0029-1245949. Epub 2011 Jan 21. — View Citation

Yamamoto N, Isayama H, Kawakami H, Sasahira N, Hamada T, Ito Y, Takahara N, Uchino R, Miyabayashi K, Mizuno S, Kogure H, Sasaki T, Nakai Y, Kuwatani M, Hirano K, Tada M, Koike K. Preliminary report on a new, fully covered, metal stent designed for the treatment of pancreatic fluid collections. Gastrointest Endosc. 2013 May;77(5):809-14. doi: 10.1016/j.gie.2013.01.009. Epub 2013 Feb 26. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of interventions performed between metal and plastic stent groups to achieve treatment success	The primary objective of this study is to compare the number of interventions performed between metal and plastic stent groups to achieve treatment success at 6 week follow-up. Re-intervention is defined as the need for repeat EUS-guided drainage of WON using the same stent type and/or DEN and/or insertion of percutaneous catheter due to inadequate treatment response following initial WON drainage. As FCSEMS have larger diameter than plastic stents, the investigators hypothesize that the no. of re-interventions performed will be lower in the FCSEMS group compared to the plastic stent group.	6 weeks
Secondary	Technical success	Successful deployment of transmural stents in to the WON cavity.	at index treatment Day 0
Secondary	Treatment success	Resolution of WON on CT scan and resolution of symptoms at 6-week outpatient follow-up (from day of hospital discharge) WITHOUT the need for cross-over to minimally invasive surgical debridement	6 week
Secondary	Treatment failure	Need for minimally-invasive surgical debridement as a consequence of inadequate endoscopic treatment response, or death as a direct consequence of WON drainage or underlying diseaseor underlying disease.	6 months
Secondary	Recurrence	Development of WON or additional Pancreatic Fluid Collection and recurrence of symptoms following initial treatment success	6 months
Secondary	Procedure duration (minutes)	Time from start of the procedure (endoscope inserted into the gastrointestinal lumen to perform transmural drainage to the end of the procedure (removal of the echoendoscope/ gastroscope/ duodenoscope from the oropharynx).	at index treatment Day 0
Secondary	Adverse events	Adverse event directly resulting from performing endoscopic drainage procedure. The severity will be graded according to a previously published consensus.	6 months
Secondary	Duration of hospitalization	Day of procedure to the day of hospital discharge	6 months
Secondary	Cost Analysis (Inpatient and outpatient costs)	Inpatient and outpatient costs of care will be calculated based on Medicare reimbursement fee structure.	6 months