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Early Versus Standard Endoscopic Interventions for Peripancreatic Fluid Collections

NCT05281458 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-06-08

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Early drainage of peripancreatic fluid collections

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

Sponsors & Collaborators

  • Second Affiliated Hospital of Soochow University

    collaborator OTHER

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    collaborator OTHER

  • Ruijin Hospital

    collaborator OTHER

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05281458 on ClinicalTrials.gov