Randomized Trial Comparing Fully Covered, Self Expanding Metal Stent (FCSEMS) and Plastic Stents for EUS- Guided Drainage of Walled -Off Necrosis (WON)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
Consenting eligible patients will sign an IRB (Institutional Review Board)-approved, written informed consent to verify their willingness to participate in this study. Informed consent will be obtained on the day of their scheduled endoscopic drainage procedure and will occur at the time of consent to undergo the endoscopic drainage procedure (standard of care). Consent for the study will be obtained by one of the participating endoscopists and/or a research assistant. Subjects will receive a copy of the signed and dated informed consent document. Original informed consent documents will be maintained on-file at each participating center and will be made available for review upon request by coordinating center team or IRB, and/or any additional oversight organizations. A note may be made in the subject's hospital chart regarding participation in the research study. Once consented and enrolled into the trial, subjects will be issued a unique code to be used on data collection forms and other research records throughout the duration of the trial.
Preparation, Imaging and Endoscopic Procedures:
Patients on anti-platelet therapy or anticoagulation
-
Warfarin is to be stopped prior to the procedure per institutional guidelines..
-
Patients on heparin:
-
Subcutaneous low molecular weight heparin (LMWH) is held for 12 hours and restarted the day after the procedure
-
Intravenous heparin drip is stopped per institutional guideline prior to the procedure and restarted 12 hours after the drainage procedure
-
Aspirin can be continued until the day of the procedure
-
Clopidogrel and other anti-platelet agents are to be stopped per institutional guidelines prior to the procedure and restarted the day after the procedure. In patients with placement of drug-eluting stents within one year, the risk of cessation of clopidogrel will have to be weighed against the risk of bleeding during the drainage procedure. In that case, cardiology may be consulted so that the best course of action can be taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age < 18 years
- •Unable to obtain consent for the procedure
- •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.
研究组 & 干预措施
Plastic Stent
Three 7 Fr OR two 10 Fr Plastic Stents will be used
干预措施: Plastic Stent (Device)
Axios FCSEMS
15 mm Axios Fully Covered Self Expanding Metal Stent
干预措施: Axios Fully Covered Self Expanding Metal Stent (Device)
结局指标
主要结局
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.
时间窗: 6 weeks
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.
Short term efficacy as measured with improvement in symptoms using Visual Analog Scale (VAS)
时间窗: 6 Weeks
Visual Analog Pain Scale Ranges. 0= No pain Ever to 10= Worst Pain. Visual faces demonstrate increased unhappiness as the numbers rise
Short term efficacy as measured with improvement in symptoms using the SF-36 questionnaire scale
时间窗: 6 weeks
SF-36 is a 36 question, patient reported survey of patient health. It is a measure of health status.
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.
时间窗: 24 Months
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.
Long term efficacy as measured with improvement in symptoms using Visual Analog Scale (VAS)
时间窗: 24 Months
Visual Analog Pain Scale Ranges. 0= No pain Ever to 10= Worst Pain. Visual faces demonstrate increased unhappiness as the numbers rise
Long term efficacy as measured with improvement in symptoms using the SF-36 questionnaire scale
时间窗: 24 Months
SF-36 is a 36 question, patient reported survey of patient health. It is a measure of health status.
次要结局
- Using the perspective of the payer, obtain and extrapolate cost data to compare direct healthcare costs(24 months from stent insertion.)
研究者
Jeffrey Easler
Assistant Professor of Medicine
Indiana University