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Early versus Standard Endoscopically-centered drainage of necrotic pancreatic fluid collections: a prospective multicenter randomized controlled study

Early versus Standard Endoscopically-centered drainage of necrotic pancreatic fluid collections: a prospective multicenter randomized controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079757
Enrollment
Unknown
Registered
2024-01-11
Start date
2024-01-25
Completion date
Unknown
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute pancreatitis

Interventions

Control Group (Delayed Drainage Group):Patients in the control group are managed with a delayed approach, waiting until the peripancreatic fluid sufficiently encapsulates to form a pseudocyst or encap
Experimental Group (Early Drainage Group):For patients meeting the screening criteria, an early drainage strategy is initiated within 24 hours of enrollment.

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: - Onset of illness less than 4 weeks. - Meets the diagnostic criteria for acute pancreatitis: According to the 2012 Atlanta classification and definition revision international consensus, the diagnosis of acute pancreatitis requires 2 of the following 3 features: 1. Abdominal pain characteristic of acute pancreatitis (acute onset of persistent, severe upper abdominal pain often radiating to the back). 2. Serum lipase activity (or amylase activity) at least 3 times greater than the upper limit of normal. 3. Abdominal CT, less commonly used MRI, or abdominal ultrasound showing characteristic changes of acute pancreatitis. - Meets the diagnostic criteria for severe acute pancreatitis: Diagnosis of acute pancreatitis with persistent (>48h) organ dysfunction (single or multiple organs). - Confirmed/highly suspected peripancreatic fluid collection with infection: Abdominal imaging (CT or MRI) suggests peripancreatic fluid with gas formation; endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) indicates positive etiology; clinical exclusion of other infection factors (lung infection, urinary tract infection, catheter-related infection, etc.) and highly suspected pancreatic infective necrosis. Meeting any one of these conditions is sufficient. - Patients with symptoms of abdominal compression due to a large amount of peripancreatic fluid (intra-abdominal hypertension/compartment syndrome), or compression of the inferior vena cava or superior mesenteric vein, or compression of the common bile duct leading to biliary dilation, or patients with persistent organ failure that cannot be relieved. - No gender restriction, age 18 years and above. - Patient or family agrees to participate in this study and signs an informed consent form, agreeing to participate in this research.

Exclusion criteria

Exclusion criteria: - Patients requiring open surgical intervention due to specific clinical situations such as intra-abdominal compartment syndrome, intra-abdominal hemorrhage, visceral perforation, etc., and thus not suitable for endoscopic or percutaneous step-up therapy. - Patients who have participated in another clinical trial within the past 3 months, or have previously undergone surgical treatment for peripancreatic fluid collection. - Patients with a confirmed diagnosis of chronic pancreatitis.

Design outcomes

Primary

MeasureTime frame
Comprehensive Complication Index (CCI);

Secondary

MeasureTime frame
AP Severity Scores; Biochemical Indicators(Serum bilirubin, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, blood amylase, blood calcium);Number of total interventions;Hospitalization Time, ICU Stay Duration, Hospitalization Costs;

Countries

China

Contacts

Public ContactBaiwen Li

Department of Gastroenterology, Shanghai general hospital

muzibowen@126.com+86 189 3089 4343

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026