NCT05281458

Early Versus Standard Endoscopic Interventions for Peripancreatic Fluid Collections

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Acute Pancreatitis
• Peripancreatic Fluid Collections
• Endoscopic Ultrasound-Guided Drainage
• Pancreatic Fluid Collections

Interventions

Type	Name	Description
PROCEDURE	Early drainage of peripancreatic fluid collections	Participants will undergo EUS guided drainage earlier (≤1 weeks) in the disease course.

Timeline

• Start date: 2021-09-15
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2022-03-16
• Last updated: 2023-06-08

Locations

1 site across 1 country: China