Clinical trial NCT06023771: Invasive Intervention of Local Complications of Acute Pancreatitis
Official title: Drainage and Debridement of Local Complications of Acute Pancreatitis: A Single-center Real-world Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Pancreatitis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized acute pancreatitis patients requiring invasive interventions.

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.


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.

Primary outcomes:
measure: Major complications or death
timeFrame: Day 1 from admission until 6 months after discharge
Secondary outcomes:
measure: Organ failure
timeFrame: Day 1 from admission until 6 months after discharge
measure: Systemic complication
timeFrame: Day 1 from admission until 6 months after discharge
measure: Enterocutaneous fistula
timeFrame: Day 1 from admission until 6 months after discharge
measure: Perforation of visceral organ
timeFrame: Day 1 from admission until 6 months after discharge
measure: Intraabdominal bleeding
timeFrame: Day 1 from admission until 6 months after discharge
measure: Pancreatic fistula
timeFrame: Day 1 from admission until 6 months after discharge
measure: New-onset diabetes
timeFrame: Day 1 from admission until 6 months after discharge
measure: Use of pancreatic enzymes
timeFrame: Day 1 from admission until 6 months after discharge
measure: Length of hospitalization
timeFrame: Day 1 from admission until the 1 day of discharge
measure: Length of intesive care
timeFrame: Day 1 from admission until the 1 day of discharge
measure: Total direct medical costs and indirect costs
timeFrame: Day 1 from admission until the 1 day of discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Dong Wu
role: PRINCIPAL_INVESTIGATOR
References: