Acute Pancreatitis
Conditions
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.
Interventions
PROCEDUREInvasive intervention for acute pancreatitis
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).
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Admission diagnosis of acute pancreatitis; * Localized complications confirmed by imaging examinations; * Voluntary participation in the study and signing of an informed consent form.
Exclusion criteria
* Improved with conservative treatment without invasive interventions for local complications during hospitalization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
China
Contacts
Primary ContactDong Wu
Outcome results
None listed