WON-MVP: Comparison of FCSEMS and Plastic Stents

Sponsor

AdventHealth (Other)

Overall Status

Completed

CT.gov ID

NCT02685865

Collaborator

(none)

Enrollment

Locations

Arms

29.6

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infected Pancreatic Necrosis Acute Pancreatic Fluid Collection Pancreatic and Peripancreatic Necrosis Pancreatic Collection Symptomatic Pancreatic Necrosis	Device: FCSEM Stent Device: Plastic Stent	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 12, 2016

Actual Primary Completion Date :

Jul 10, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: FCSEM Stent 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.	Device: FCSEM Stent Hot Axios Fully covered self-expandable metal stent - Boston Scientific Other Names: Fully covered self-expandable metal stent
Active Comparator: Plastic Stents 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.	Device: Plastic Stent 7 French 4 cm double pigtail plastic stent - Cook 7 French 4 cm double pigtail plastic stent - Boston Scientific

Arm

Intervention/Treatment

Active Comparator: FCSEM Stent

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.

Device: FCSEM Stent

Hot Axios Fully covered self-expandable metal stent - Boston Scientific

Other Names:

Fully covered self-expandable metal stent

Active Comparator: Plastic Stents

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.

Device: Plastic Stent

7 French 4 cm double pigtail plastic stent - Cook 7 French 4 cm double pigtail plastic stent - Boston Scientific

Outcome Measures

Primary Outcome Measures

The number of interventions performed between metal and plastic stent groups to achieve treatment success [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
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

Exclusion Criteria:

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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Interventional Endoscopy - Florida Hospital Orlando	Orlando	Florida	United States	32803
2	Florida Hospital Center for Interventional Endoscopy	Orlando	Florida	United States	32803

Sponsors and Collaborators

AdventHealth

Investigators

Principal Investigator: Shyam Varadarajulu, MD, Florida Hospital Orlando

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

AdventHealth

ClinicalTrials.gov Identifier:

NCT02685865

Other Study ID Numbers:

837579

First Posted:

Feb 19, 2016

Last Update Posted:

Feb 11, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by AdventHealth

pancreatic fluid collection; pancreatic necrosis; stent;

Additional relevant MeSH terms:

Pancreatitis, Acute Necrotizing

Necrosis

Study Results

No Results Posted as of Feb 11, 2019