Early Versus Standard Endoscopic Interventions for Peripancreatic Fluid Collections

Study Overview
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Brief Summary
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Acute pancreatitis is a complex gastrointestinal disease with a variable course that is often difficult to predict early in its development. The majority of cases are mild, self-limited, and follow an uncomplicated course. However, 10-20% of cases can be associated with pancreatic or peripancreatic fluid collections, or both. Infected necrosis complicates 10% of all acute pancreatitis episodes and is associated with a mortality of 15-20%. Current guidelines for necrotizing pancreatitis recommend to postpone drainage until 4 or more weeks after initial presentation to allow collections to walled-off. However, evidence of infection with clinical deterioration despite maximum support may mandate earlier intervention. It is unclear whether such delay is needed for drainage or whether earlier endoscopic intervention could actually be beneficial in the current approach. The aims of this randomized, controlled, multicenter study is to evaluate whether early endoscopic drainage in patients with peripancreatic fluid collection is superior to postponed intervention in the current practice.

Detailed Description
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EUS guided drainage is now the preferred route for peripancreatic fluid collections (PFC). It belongs to transmural drainage and is accomplished by creating a fistula and placing a stent between the gastric or duodenal lumen and the PFC. The size of the PFC and percentage of solid debris were noted prior to puncture, and the optimal site of transluminal puncture was identified using EUS. Participants will be randomly allocated to either the intervention or the control group. Participants in the intervention group will undergo EUS guided drainage earlier (≤1 weeks) in the disease course. The follow-up duration is 6 months from randomization. All patients undergo imaging (contrast enhanced computed tomography) at 3- and 6-months post randomization.

Official Title
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Postponed or Early Drainage of Peripancreatic Fluid Collections: a Randomized Controlled Multicenter Study

Conditions
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Acute Pancreatitis, Peripancreatic Fluid Collections, Endoscopic Ultrasound-Guided Drainage, Pancreatic Fluid Collections

Intervention / Treatment
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* Procedure: Early drainage of peripancreatic fluid collections


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with PFC; All patients with PFC will be screened for eligibility including a protocolized approach; Patients admitted within 72 hours of onset Exclusion Criteria: More than 30 days after onset of acute pancreatitis Pregnant women Documented chronic pancreatitis Inability to gave informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early endoscopic interventions for AP<br>Participants in the intervention group will undergo EUS guided drainage earlier (≤1 weeks) in the disease course. | Procedure: Early drainage of peripancreatic fluid collections<br>* Participants will undergo EUS guided drainage earlier (≤1 weeks) in the disease course.<br>|
| No Intervention: Standard endoscopic interventions for AP<br>Participants in the control group will have postponed drainage, preferably until AP progress to the walled-off necrosis stage. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Bedside Index of Severe Acute Pancreatitis (BISAP) | Comparison of BISAP changes between the two groups after different treatments. Also compare the number of participants with BISAP ≥3. BISAP was designed as a predictor of mortality based on 5 variables: blood urea nitrogen (BUN) level greater than 25 mg/dL, impaired mental status, systemic inflammatory response syndrome (SIRS), age older than 60 years, or radiographic evidence of pleural effusion within the first 24 hours of admission. A BISAP score of 3 or greater was associated with developing organ failure, and a higher scores mean a worse outcome. | 1-4 week | 
| Number of Participants with New-onset multi-organ failure after intervention |  | 1-4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of mortality |  | 6 months | 
| Length of hospital stay |  | 3 months | 
| Length of ICU stays |  | up to 3 months | 
| Related complications |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Pancreatitis, Peripancreatic Fluid Collections, Endoscopic Ultrasound, Endoscopic Drainage