Invasive Intervention of Local Complications of Acute Pancreatitis

Study Overview
=================
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.

Official Title
-----------------
Drainage and Debridement of Local Complications of Acute Pancreatitis: A Single-center Real-world Prospective Study

Conditions
-----------------
Acute Pancreatitis

Intervention / Treatment
-----------------
* Procedure: Invasive intervention for acute pancreatitis


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute pancreatitis requiring invasive intervention<br>Single-center cohort of acute pancreatitis patients requiring invasive intervention for the treatment of local complications during the whole course of disease. | Procedure: Invasive intervention for acute pancreatitis<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major 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. | Day 1 from admission until 6 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ failure | New-onset ( not present at any time in the 24 hours before first intervention) pulmonary failure, circulatory failure, or renal failure | 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 | 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 | Day 1 from admission until 6 months after discharge | 
| Perforation of visceral organ | Perforation requiring surgical, radiologic, or endoscopic intervention | Day 1 from admission until 6 months after discharge | 
| Intraabdominal bleeding | Requiring surgical, radiologic, or endoscopic intervention | 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 | 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 | 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 | Day 1 from admission until 6 months after discharge | 
| Length of hospitalization | Total days of hospitalization for the management of acute pancreatitis | 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 | 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 | Day 1 from admission until the 1 day of discharge |