Invasive Intervention of Local Complications of Acute Pancreatitis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking Union Medical College Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Admission diagnosis of acute pancreatitis;

Localized complications confirmed by imaging examinations;

Voluntary participation in the study and signing of an informed consent form.

Disqualifiers

Improved with conservative treatment without invasive interventions for local complications during hospitalization.

Trial population

Hospitalized acute pancreatitis patients requiring invasive interventions.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Invasive intervention for acute pancreatitis

    Procedure/Surgery

    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).

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Acute pancreatitis requiring invasive intervention1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1 from admission until 6 months after discharge

Secondary outcomes

1

Organ failure

New-onset ( not present at any time in the 24 hours before first intervention) pulmonary failure, circulatory failure, or renal failure

Time frame
Day 1 from admission until 6 months after discharge
2

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

Time frame
Day 1 from admission until 6 months after discharge
3

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

Time frame
Day 1 from admission until 6 months after discharge
4

Perforation of visceral organ

Perforation requiring surgical, radiologic, or endoscopic intervention

Time frame
Day 1 from admission until 6 months after discharge

Other outcomes

Sponsors and contacts

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