Comparing Fully Covered, Self Expanding Metal Stent (FCSEMS) and Plastic Stents for EUS- Guided Drainage of WON

NCT02718092 | Withdrawn DMC FDA Device

• 1 other identifier: 1512035809
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-center, single-blinded, randomized trial comparing AXIOS FCSEMS (Fully Covered Self Expanding Metal Stent) and plastic stents for EUS (Endoscopic Ultrasound)-guided management of infected and/or symptomatic WON (Walled Off Necrosis). Patients will be randomized to either FCSEMS or plastic stents for EUS-guided drainage of WON in a 1:1 manner. Following EUS-guided drainage patients in both groups will be assessed pre- procedure, pre -discharge, weeks 1, 6 and months 3, 6, 12 and 24 months. Information will also be collected from any subsequent hospital admissions related to their walled-off necrosis.

Conditions

Walled-off Necrosis

Outcome Measures

Primary Outcomes (6)

• Short term efficacy as measured by interval decrease in size in WON (Walled Off Necrosis) collection to 10% of the pre-treatment volume as measured in centimeters^3.

  Hypothesis: Short term efficacy for radiographic resolution of symptomatic walled off necrosis. Diameter of the collection on MRI/CT axial and coronal imaging sections will be used to calculate volume in centimeters \^3.

  6 weeks

• Short term efficacy as measured with improvement in symptoms using Visual Analog Scale (VAS)

  Visual Analog Pain Scale Ranges. 0= No pain Ever to 10= Worst Pain. Visual faces demonstrate increased unhappiness as the numbers rise

  6 Weeks

• Short term efficacy as measured with improvement in symptoms using the SF-36 questionnaire scale

  SF-36 is a 36 question, patient reported survey of patient health. It is a measure of health status.

  6 weeks

• Long term efficacy as measured by interval decrease in size in WON collection to 10% of the pre-treatment volume as measured in centimeters^3.

  Hypothesis: Long term efficacy for radiographic resolution of symptomatic walled off necrosis. Diameter of the collection on MRI/CT axial and coronal imaging sections will be used to calculate volume in centimeters \^3.

  24 Months

• Long term efficacy as measured with improvement in symptoms using Visual Analog Scale (VAS)

  Visual Analog Pain Scale Ranges. 0= No pain Ever to 10= Worst Pain. Visual faces demonstrate increased unhappiness as the numbers rise

  24 Months

• Long term efficacy as measured with improvement in symptoms using the SF-36 questionnaire scale

  SF-36 is a 36 question, patient reported survey of patient health. It is a measure of health status.

  24 Months

Secondary Outcomes (1)

• Using the perspective of the payer, obtain and extrapolate cost data to compare direct healthcare costs

  24 months from stent insertion.

Study Arms (2)

Plastic Stent

ACTIVE COMPARATOR

Three 7 Fr OR two 10 Fr Plastic Stents will be used

Device: Plastic Stent

Axios FCSEMS

ACTIVE COMPARATOR

15 mm Axios Fully Covered Self Expanding Metal Stent

Device: Axios Fully Covered Self Expanding Metal Stent

Interventions

Plastic Stent DEVICE

Subjects who are randomized to this arm will receive a plastic stent

Plastic Stent

Axios Fully Covered Self Expanding Metal Stent DEVICE

Subjects who are randomized to this arm will receive the Axios FCEMS

Axios FCSEMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• All WON centered within the pancreatic/peri-pancreatic space not requiring percutaneous drainage, ≥ 6cm, located within 2cm of the enteric wall, not extending into the flanks or pelvis
• WON with single loculation, with no extension into the flanks, pelvis or into the root of the small bowel mesentery. Collections should have an estimated solid component of = or \>25% based on cross sectional imaging and/or endosonographic evaluation of the collection at the time of study procedure.
• Suspected/confirmed infected WON (defined as temp ≥ 100.5°F, serum WBC ≥ 15x199/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) at a time interval of ≥ 4 weeks from attack of acute pancreatitis complicated by pancreatic necrosis
• Documented history of acute or chronic pancreatitis
• a) Acute pancreatitis is diagnosed if 2 of the following 3 criteria are met: i) Abdominal pain characteristic of acute pancreatitis ii) Serum lipase/amylase ≥ x3 upper limit of normal iii) Characteristic radiological findings of acute pancreatitis on CECT/MRI/US abdomen, such as homogeneous enhancement of pancreatic parenchyma, standing of peripancreatic fat (1) b) Chronic pancreatitis is diagnosed if characteristic radiological changes are seen on CT/MRI with MRCP (such as pancreatic atrophy, dilated pancreatic duct, pancreatic calcification) (11) or EUS (≥5/9 of Rosement criteria) (12)
• Able to undergo general anesthesia

You may not qualify if:

• Age \< 18 years
• Unable to obtain consent for the procedure
• Pregnancy
• Irreversible coagulopathy: INR \> 1.5, platelets \< 50 x 109/L
• Use of anticoagulants that cannot be discontinued for the procedure
• Unable to tolerate general anesthesia
• WON with ≥ 3 loculations
• WON that is not accessible for EUS-guided drainage
• Percutaneous drainage of WON is required or performed prior to EUS-guided drainage
• Prior endoscopic, percutaneous or surgical drainage procedure(s) for pancreatic/peri-pancreatic fluid collections.
• Contraindication to endoscopic drainage: Gastrectomy with Billroth II, gastric bariatric surgery, prior pancreatic surgery, prior esophagectomy, cirrhosis.

Sponsors & Collaborators

• Indiana University: lead

Study Officials

• Jeffrey Easler, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 24, 2016
• Study Start: February 1, 2016
• Primary Completion: August 23, 2017
• Study Completion: August 23, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share