Invasive Intervention of Local Complications of Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06023771
• Other study ID #: K4433
• Status: Recruiting
• Start date: October 2023
• Est. completion date: December 2026

Study information

• Verified date: August 2023
• Source: Peking Union Medical College Hospital
• Contact: Dong Wu
• Phone: 18612671010
• Email: wudong[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

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).

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Perforation of visceral organ	Perforation requiring surgical, radiologic, or endoscopic intervention	Day 1 from admission until 6 months after discharge
Secondary	Intraabdominal bleeding	Requiring surgical, radiologic, or endoscopic intervention	Day 1 from admission until 6 months after discharge
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of hospitalization	Total days of hospitalization for the management of acute pancreatitis	Day 1 from admission until the 1 day of discharge
Secondary	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
Secondary	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