Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT02718092
Eligibility Criteria:
Inclusion Criteria:
1. 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)
2. 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
3. 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.
4. 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
5. 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
6. 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)
7. Able to undergo general anesthesia
Exclusion Criteria:
1. Age \< 18 years
2. Unable to obtain consent for the procedure
3. Pregnancy
4. Irreversible coagulopathy: INR \> 1.5, platelets \< 50 x 109/L
5. Use of anticoagulants that cannot be discontinued for the procedure
6. Unable to tolerate general anesthesia
7. WON with ≥ 3 loculations
8. WON that is not accessible for EUS-guided drainage
9. Percutaneous drainage of WON is required or performed prior to EUS-guided drainage
10. Prior endoscopic, percutaneous or surgical drainage procedure(s) for pancreatic/peri-pancreatic fluid collections.
11. Contraindication to endoscopic drainage: Gastrectomy with Billroth II, gastric bariatric surgery, prior pancreatic surgery, prior esophagectomy, cirrhosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02718092
Study Brief:
Protocol Section:
NCT02718092