Invasive Intervention of Local Complications of Acute Pancreatitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Procedure: Invasive intervention for acute pancreatitis

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Dong Wu; Phone Number: 18612671010; Email: wudong@pumch.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Dong Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized acute pancreatitis patients requiring invasive interventions.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute pancreatitis requiring invasive intervention; Single-center cohort of acute pancreatitis patients requiring invasive intervention for the treatment of local complications during the whole course of disease.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Dong Wu, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: K4433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No