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.
Study Type
OBSERVATIONAL
Enrollment
100
Invasive interventions include drainage (endoscopic transmural drainage, imaging-guided percutaneous catheter drainage) and debridement (endoscopic debridement, videoscopic assisted retroperitoneal debridement, laparoscopic surgical debridement, open surgical debridement).
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGMajor complications or death
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.
Time frame: Day 1 from admission until 6 months after discharge
Organ failure
New-onset ( not present at any time in the 24 hours before first intervention) pulmonary failure, circulatory failure, or renal failure
Time frame: Day 1 from admission until 6 months after discharge
Systemic complication
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
Time frame: Day 1 from admission until 6 months after discharge
Enterocutaneous fistula
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
Time frame: Day 1 from admission until 6 months after discharge
Perforation of visceral organ
Perforation requiring surgical, radiologic, or endoscopic intervention
Time frame: Day 1 from admission until 6 months after discharge
Intraabdominal bleeding
Requiring surgical, radiologic, or endoscopic intervention
Time frame: Day 1 from admission until 6 months after discharge
Pancreatic fistula
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
Time frame: Day 1 from admission until 6 months after discharge
New-onset diabetes
Insulin or oral antidiabetic drugs required 6 mo after discharge; this requirement was not present before onset of pancreatitis
Time frame: Day 1 from admission until 6 months after discharge
Use of pancreatic enzymes
Oral pancreatic-enzyme supplementation required to treat clinical symptoms of steatorrhea 6 mo after discharge; this requirement was not present before onset of pancreatitis
Time frame: Day 1 from admission until 6 months after discharge
Length of hospitalization
Total days of hospitalization for the management of acute pancreatitis
Time frame: Day 1 from admission until the 1 day of discharge
Length of intesive care
Total days in intesive care unit for the management of acute pancreatitis
Time frame: Day 1 from admission until the 1 day of discharge
Total direct medical costs and indirect costs
Total direct medical costs and indirect costs during admission
Time frame: Day 1 from admission until the 1 day of discharge
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