Early Versus Standard Endoscopic Interventions for Peripancreatic Fluid Collections

June 7, 2023 updated by: Baiwen Li, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Recruiting
        • Shanghai General Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Bedside Index of Severe Acute Pancreatitis (BISAP)
Time Frame: 1-4 week
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
Time Frame: 1-4 week
1-4 week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Ruijin Hospital
Second Affiliated Hospital of Soochow University
Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 19, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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