Early Versus Standard Endoscopic Interventions for Peripancreatic Fluid Collections

Shanghai Jiao Tong University

Status: Enrolling

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

Treatments: Procedure: Early drainage of peripancreatic fluid collections

Study type: Interventional

Funder types: Other

Identifiers

NCT05281458

2021-114

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Early endoscopic interventions for AP

Experimental group

Description:

Participants in the intervention group will undergo EUS guided drainage earlier (≤1 weeks) in the disease course.

Treatment:

Procedure: Early drainage of peripancreatic fluid collections

Standard endoscopic interventions for AP

No Intervention group

Description:

Participants in the control group will have postponed drainage, preferably until AP progress to the walled-off necrosis stage.