Infected Pancreatic NecrosisWON-MVPNCT02685865

Comparison of FCSEMS and Plastic Stents

A study testing FCSEM Stent and Plastic Stent in people with Infected Pancreatic Necrosis and Acute Pancreatic Fluid Collection, run by AdventHealth at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Infected Pancreatic Necrosis, Acute Pancreatic Fluid Collection, Pancreatic and Peripancreatic Necrosis
What is being tested?: FCSEM Stent and Plastic Stent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 2 sitesUnited States
Study dates: 12 Feb 2016to Aug 2018
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

The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
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.
Males or females ≥ 18 years of age.
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).
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
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.

Show all 12Show fewer

Documented history of acute or chronic pancreatitis:
Acute pancreatitis is diagnosed if 2 of the following 3 criteria are met:
Abdominal pain characteristic of acute pancreatitis
Serum lipase/amylase ≥ x3 upper limit of normal
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)
Able to undergo general anesthesia

Who cannot join

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.
Irreversible coagulopathy (INR >1.5, thrombocytopenia with platelet count <50,000/mL)
Has surgically altered gastrointestinal anatomy such as but not limited to Billroth II, Roux-en-Y, gastric bypass
Age < 18 years
Unable to obtain consent for the procedure from either the patient or LAR
Use of anticoagulants that cannot be discontinued for the procedure

Show all 9Show fewer

Unable to tolerate general anesthesia
WON that is not accessible for EUS-guided drainage
Percutaneous drainage of WON is required or performed prior to EUS-guided drainage

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Center for Interventional Endoscopy - Florida Hospital Orlando
Orlando, Florida, 32803
Florida Hospital Center for Interventional Endoscopy
Orlando, Florida, 32803

Other trials in United States

About this study

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

Read the detailed 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.

Conditions: Infected Pancreatic Necrosis, Acute Pancreatic Fluid Collection, Pancreatic and Peripancreatic Necrosis, Pancreatic Collection, Symptomatic Pancreatic Necrosis
Being tested: FCSEM Stent, Plastic Stent
Keywords: pancreatic fluid collection; pancreatic necrosis; stent;
Medical subject headings: Pancreatitis, Pancreatitis, Acute Necrotizing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FCSEM StentDevice
Also called Fully covered self-expandable metal stent
Hot Axios Fully covered self-expandable metal stent - Boston Scientific
Plastic StentDevice
7 French 4 cm double pigtail plastic stent - Cook 7 French 4 cm double pigtail plastic stent - Boston Scientific

Study groups in NCT02685865
Study group	Role	What they receive
FCSEM Stent	Active comparator	WON is first identified using EUS and punctured using a 19 gauge needle. 10 ml of fluid is aspirated and sent for gram stain and culture with sensitivities. Using a catheter-based stent delivery system with a 15mm AXIOS stent mounted onto it is inserted into the echoendoscope, and introduced into the WON cavity so that the stent lies within both the WON and enteric lumen. The stent is then deployed so that one flange of the stent is located within the WON cavity and the other flange is located within the enteric lumen. Receives: Device: FCSEM Stent
Plastic Stents	Active comparator	WON is first identified using EUS, and punctured using a 19 gauge needle. 10 ml of the WON fluid is aspirated and sent for gram stain and culture with sensitivities. A 0.025 or 0.035 inch guidewire is inserted into the WON through the fine needle aspiration (FNA) needle. A transmural tract is created using an Endoscopic Retrograde Cholangiopancreatography(ERCP) catheter (with the use of a needle knife catheter ± cautery if needed), and then dilated using a 12-13.5-15mm Controlled Radial Expansion (CRE) balloon to a maximum size of 15mm if technically possible. Two or three 7 French plastic stents are inserted through the transmural tract into the WON cavity. Receives: Device: Plastic Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 weeks

Secondary outcomes (8)

Technical success
Successful deployment of transmural stents in to the WON cavity.
Measured: at index treatment Day 0
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
Measured: 6 week
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.
Measured: 6 months
Recurrence
Development of WON or additional Pancreatic Fluid Collection and recurrence of symptoms following initial treatment success
Measured: 6 months
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).
Measured: at index treatment Day 0
Adverse events
Adverse event directly resulting from performing endoscopic drainage procedure. The severity will be graded according to a previously published consensus.
Measured: 6 months
Duration of hospitalization
Day of procedure to the day of hospital discharge
Measured: 6 months
Cost Analysis (Inpatient and outpatient costs)
Inpatient and outpatient costs of care will be calculated based on Medicare reimbursement fee structure.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Feb 2016Aug 2018

First posted19 Feb 2016 (estimated)
Study start12 Feb 2016
Primary completion10 Jul 2018
Study completionAug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Infected 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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02685865
Sponsor's protocol ID: 837579
Acronym: WON-MVP
Status last verified: Feb 2019
First submitted: 24 Nov 2015
Last updated: 11 Feb 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 23100216
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.
PubMed 22610008
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.
PubMed 19243764
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.
PubMed 21786063
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.
PubMed 21259182
Seifert H, Biermer M, Schmitt W, Jurgensen C, Will U, Gerlach R, Kreitmair C, Meining A, Wehrmann T, Rosch 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.
PubMed 19282306
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.
PubMed 20432209
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.
PubMed 22407382
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.
PubMed 23453183
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. No abstract available.
PubMed 20189503
Forsmark CE. Management of chronic pancreatitis. Gastroenterology. 2013 Jun;144(6):1282-91.e3. doi: 10.1053/j.gastro.2013.02.008.
PubMed 23622138
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.
PubMed 21170612
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.
PubMed 25333872
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.
PubMed 29858393

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Infected Pancreatic Necrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial Comparing Fully Covered, Self-Expanding Metal Stent and Plastic Stents for Endoscopic Ultrasound-guided Drainage of Walled-off Necrosis
ClinicalTrials.gov ID: NCT02685865
Acronym / sponsor ID: WON-MVP / 837579
Conditions: Infected Pancreatic Necrosis, Acute Pancreatic Fluid Collection, Pancreatic and Peripancreatic Necrosis, Pancreatic Collection, Symptomatic Pancreatic Necrosis
Keywords: pancreatic fluid collection; pancreatic necrosis; stent;
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: AdventHealthUniversity, hospital or other
Study start: 12 Feb 2016 (actual)
Primary completion: 10 Jul 2018 (actual)
Study completion: Aug 2018 (actual)
First posted: 19 Feb 2016 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
FCSEM Stent	Active comparator	Device: FCSEM StentWON is first identified using EUS and punctured using a 19 gauge needle. 10 ml of fluid is aspirated and sent for gram stain and culture with sensitivities. Using a catheter-based stent delivery system with a 15mm AXIOS stent mounted onto it is inserted into the echoendoscope, and introduced into the WON cavity so that the stent lies within both the WON and enteric lumen. The stent is then deployed so that one flange of the stent is located within the WON cavity and the other flange is located within the enteric lumen.
Plastic Stents	Active comparator	Device: Plastic StentWON is first identified using EUS, and punctured using a 19 gauge needle. 10 ml of the WON fluid is aspirated and sent for gram stain and culture with sensitivities. A 0.025 or 0.035 inch guidewire is inserted into the WON through the fine needle aspiration (FNA) needle. A transmural tract is created using an Endoscopic Retrograde Cholangiopancreatography(ERCP) catheter (with the use of a needle knife catheter ± cautery if needed), and then dilated using a 12-13.5-15mm Controlled Radial Expansion (CRE) balloon to a maximum size of 15mm if technically possible. Two or three 7 French plastic stents are inserted through the transmural tract into the WON cavity.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
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.
Males or females ≥ 18 years of age.
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).
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

Key exclusion criteria (9 listed)

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.
Irreversible coagulopathy (INR >1.5, thrombocytopenia with platelet count <50,000/mL)
Has surgically altered gastrointestinal anatomy such as but not limited to Billroth II, Roux-en-Y, gastric bypass
Age < 18 years
Unable to obtain consent for the procedure from either the patient or LAR

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
FCSEM StentAlso: Fully covered self-expandable metal stentHot Axios Fully covered self-expandable metal stent - Boston Scientific	Device	FCSEM Stent
Plastic Stent7 French 4 cm double pigtail plastic stent - Cook 7 French 4 cm double pigtail plastic stent - Boston Scientific	Device	Plastic Stents

Primary outcome

The number of interventions performed between metal and plastic stent groups to achieve treatment success
Time frame: 6 weeks
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.

8 secondary outcomes

Technical success
Time frame: at index treatment Day 0
Treatment success
Time frame: 6 week
Treatment failure
Time frame: 6 months
Recurrence
Time frame: 6 months
Procedure duration (minutes)
Time frame: at index treatment Day 0
Adverse events
Time frame: 6 months
Duration of hospitalization
Time frame: 6 months
Cost Analysis (Inpatient and outpatient costs)
Time frame: 6 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 11 Feb 2019.
Background: PubMed 23100216Banks 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.
Background: PubMed 22610008van 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.
Background: PubMed 19243764Gardner 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.
Background: PubMed 21786063Varadarajulu 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.
Background: PubMed 21259182Will 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.
Background: PubMed 19282306Seifert H, Biermer M, Schmitt W, Jurgensen C, Will U, Gerlach R, Kreitmair C, Meining A, Wehrmann T, Rosch 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.
Background: PubMed 20432209Belle 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.
Background: PubMed 22407382Berzosa 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.
Background: PubMed 23453183Yamamoto 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.
Background: PubMed 20189503Cotton 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. No abstract available.
Background: PubMed 23622138Forsmark CE. Management of chronic pancreatitis. Gastroenterology. 2013 Jun;144(6):1282-91.e3. doi: 10.1053/j.gastro.2013.02.008.
Background: PubMed 21170612Stevens 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.
Individual participant dataSharing planned: No

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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.

Shyam Varadarajulu, MD principal investigator

Florida Hospital Orlando

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FCSEM Stent and Plastic Stent in people with Infected Pancreatic Necrosis and Acute Pancreatic Fluid Collection, run by AdventHealth at 2 sites in United States.

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 9 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 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

The number of interventions performed between metal and plastic stent groups to achieve treatment success (time frame: 6 weeks). 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 NCT02685865, which also lists 14 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 11 Feb 2019.