Invasive Intervention of Local Complications of Acute Pancreatitis

• ClinicalTrials.gov Identifier: NCT06023771
• Recruitment Status: Recruiting
• First Posted: September 5, 2023
• Last Update Posted: September 5, 2023
• Sponsor: Peking Union Medical College Hospital
• Information provided by (Responsible Party): Peking Union Medical College Hospital

Tracking Information

• First Submitted Date: August 17, 2023
• First Posted Date: September 5, 2023
• Last Update Posted Date: September 5, 2023
• Estimated Study Start Date: October 2023
• Estimated Primary Completion Date: October 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 4, 2023)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 4, 2023)

• 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
• 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
• 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
• Perforation of visceral organ [ Time Frame: Day 1 from admission until 6 months after discharge ]
  Perforation requiring surgical, radiologic, or endoscopic intervention
• Intraabdominal bleeding [ Time Frame: Day 1 from admission until 6 months after discharge ]
  Requiring surgical, radiologic, or endoscopic intervention
• 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
• 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
• 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
• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Invasive Intervention of Local Complications of Acute Pancreatitis
• Official Title: Drainage and Debridement of Local Complications of Acute Pancreatitis: A Single-center Real-world Prospective Study
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Hospitalized acute pancreatitis patients requiring invasive interventions.
• Condition: Acute 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).

Study Groups/Cohorts

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.

Intervention: Procedure: Invasive intervention for acute pancreatitis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 4, 2023): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2026
• Estimated Primary Completion Date: October 2026 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

Contact: Dong Wu; 18612671010; wudong@pumch.cn

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT06023771
• Other Study ID Numbers: K4433
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Peking Union Medical College Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Peking Union Medical College Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dong Wu; Peking Union Medical College Hospital

• PRS Account: Peking Union Medical College Hospital
• Verification Date: August 2023