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Invasive Intervention of Local Complications of Acute Pancreatitis

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

Study Description
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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.

Condition or disease Intervention/treatment
Acute Pancreatitis Procedure: Invasive intervention for acute pancreatitis

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drainage and Debridement of Local Complications of Acute Pancreatitis: A Single-center Real-world Prospective Study
Estimated Study Start Date : October 2023
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Groups and Cohorts
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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).


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized acute pancreatitis patients requiring invasive interventions.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06023771


Contacts
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Contact: Dong Wu 18612671010 wudong@pumch.cn

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Dong Wu         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Dong Wu Peking Union Medical College Hospital
More Information
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT06023771    
Other Study ID Numbers: K4433
First Posted: September 5, 2023    Key Record Dates
Last Update Posted: September 5, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases