Early Versus Standard Endoscopic Interventions for Peripancreatic Fluid Collections

NCT ID: NCT05281458

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early endoscopic interventions for AP

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

Group Type: EXPERIMENTAL

Early drainage of peripancreatic fluid collections

Intervention Type: PROCEDURE

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

Standard endoscopic interventions for AP

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early drainage of peripancreatic fluid collections

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Baiwen Li

Director of Digestive Endoscopy Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai General Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Baiwen Li

Role: CONTACT

muzibowen@126.com

(+86)021-37798977

Kui Peng

Role: CONTACT

drpeng@alumni.sjtu.edu.cn

(+86)021-37798977

Facility Contacts

Xiaodong Sun

Role: primary

sfph_edu2@163.com

(+86)021-63240090

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Other Identifiers

2021-114

Identifier Type: -

Identifier Source: org_study_id