Invasive Intervention of Local Complications of Acute Pancreatitis
- Conditions
- Acute Pancreatitis
- Interventions
- Procedure: Invasive intervention for acute pancreatitis
- Registration Number
- NCT06023771
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
Strategies for invasive intervention in acute pancreatitis include sequential or combined use of multiple drainage and debridement modalities. The more widely used is the step-up approach, which requires an individualized and multidisciplinary (internal medicine, interventional radiology, endoscopy, surgery, critical care medicine, and nutritionists) approach. The available evidence from randomized controlled studies is from highly selected subject populations, and it is unclear whether the results can be applied to complex clinical situations in real clinics, and the optimal strategy for drainage of peripancreatic lesions in different patients still needs to be evaluated in the real world. This study intends to establish a prospective single-center cohort for real-world analysis to collect comprehensive clinic information and clinical outcomes, to evaluate the effectiveness and safety of existing intervention strategies, especially the timing and modality of interventions, in real-world clinical practice, and to explore the key factors affecting patient prognosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Admission diagnosis of acute pancreatitis;
- Localized complications confirmed by imaging examinations;
- Voluntary participation in the study and signing of an informed consent form.
- Improved with conservative treatment without invasive interventions for local complications during hospitalization.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acute pancreatitis requiring invasive intervention Invasive intervention for acute pancreatitis Single-center cohort of acute pancreatitis patients requiring invasive intervention for the treatment of local complications during the whole course of disease.
- Primary Outcome Measures
Name Time Method Major complications or death Day 1 from admission until 6 months after discharge A composite of major complications (i.e., new-onset multiple organ failure or systemic complications, enterocutaneous fistula or perforation of a visceral organ requiring intervention, or intraabdominal bleeding requiring intervention) or death during admission or during the 6 months after discharge.
- Secondary Outcome Measures
Name Time Method Systemic complication Day 1 from admission until 6 months after discharge New-onset ( not present at any time in the 24 hours before first intervention) systematic complications such as disseminated intravascular coagulation, severe metabolic disturbance, and gastrointestinal bleeding
Enterocutaneous fistula Day 1 from admission until 6 months after discharge Secretion of fecal material from a percutaneous drain or drainage canal after removal of drains or from a surgical wound, either from small or large bowel; confirmed by imaging or during surgery
Perforation of visceral organ Day 1 from admission until 6 months after discharge Perforation requiring surgical, radiologic, or endoscopic intervention
Organ failure Day 1 from admission until 6 months after discharge New-onset ( not present at any time in the 24 hours before first intervention) pulmonary failure, circulatory failure, or renal failure
Length of intesive care Day 1 from admission until the 1 day of discharge Total days in intesive care unit for the management of acute pancreatitis
Total direct medical costs and indirect costs Day 1 from admission until the 1 day of discharge Total direct medical costs and indirect costs during admission
Intraabdominal bleeding Day 1 from admission until 6 months after discharge Requiring surgical, radiologic, or endoscopic intervention
Pancreatic fistula Day 1 from admission until 6 months after discharge Output, through a percutaneous drain or drainage canal after removal of drains or from a surgical wound, of any measurable volume of fluid with an amylase content \>3 times the serum amylase level
New-onset diabetes Day 1 from admission until 6 months after discharge Insulin or oral antidiabetic drugs required 6 mo after discharge; this requirement was not present before onset of pancreatitis
Use of pancreatic enzymes Day 1 from admission until 6 months after discharge Oral pancreatic-enzyme supplementation required to treat clinical symptoms of steatorrhea 6 mo after discharge; this requirement was not present before onset of pancreatitis
Length of hospitalization Day 1 from admission until the 1 day of discharge Total days of hospitalization for the management of acute pancreatitis
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China