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Recruiting NCT06023771

Invasive Intervention of Local Complications of Acute Pancreatitis

Observational Acute Pancreatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Invasive intervention for acute pancreatitis.
Who it may be relevant to
Registry conditions: Acute Pancreatitis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure Invasive 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).

Primary outcome measures

  • Major complications or death [Time frame: Day 1 from admission until 6 months after discharge]
Secondary outcome measures (11)
  • Organ failure [Time frame: Day 1 from admission until 6 months after discharge]
  • Systemic complication [Time frame: Day 1 from admission until 6 months after discharge]
  • Enterocutaneous fistula [Time frame: Day 1 from admission until 6 months after discharge]
  • Perforation of visceral organ [Time frame: Day 1 from admission until 6 months after discharge]
  • Intraabdominal bleeding [Time frame: Day 1 from admission until 6 months after discharge]
  • Pancreatic fistula [Time frame: Day 1 from admission until 6 months after discharge]
  • New-onset diabetes [Time frame: Day 1 from admission until 6 months after discharge]
  • Use of pancreatic enzymes [Time frame: Day 1 from admission until 6 months after discharge]
  • Length of hospitalization [Time frame: Day 1 from admission until the 1 day of discharge]
  • Length of intesive care [Time frame: Day 1 from admission until the 1 day of discharge]
  • Total direct medical costs and indirect costs [Time frame: Day 1 from admission until the 1 day of discharge]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT06023771 · K4433

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗