Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06023771

Invasive Intervention of Local Complications of Acute Pancreatitis

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Dong Wu

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Invasive intervention for acute pancreatitis

Procedure

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 outcomes

  1. Major complications or death

    Time frame: 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 outcomes

  1. Organ failure

    Time frame: 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

  2. Systemic complication

    Time frame: 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

  3. Enterocutaneous fistula

    Time frame: 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

  4. Perforation of visceral organ

    Time frame: Day 1 from admission until 6 months after discharge

    Perforation requiring surgical, radiologic, or endoscopic intervention

  5. Intraabdominal bleeding

    Time frame: Day 1 from admission until 6 months after discharge

    Requiring surgical, radiologic, or endoscopic intervention

  6. Pancreatic fistula

    Time frame: 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

  7. New-onset diabetes

    Time frame: 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

  8. Use of pancreatic enzymes

    Time frame: 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

  9. Length of hospitalization

    Time frame: Day 1 from admission until the 1 day of discharge

    Total days of hospitalization for the management of acute pancreatitis

  10. Length of intesive care

    Time frame: Day 1 from admission until the 1 day of discharge

    Total days in intesive care unit for the management of acute pancreatitis

  11. Total direct medical costs and indirect costs

    Time frame: Day 1 from admission until the 1 day of discharge

    Total direct medical costs and indirect costs during admission

Study contacts

Contact information is provided by the study sponsor or research team.

Dong Wu

CONTACT

[email protected]

18612671010

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2023
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.