Tracking ENcapsulation of Pancreatic Collections in Acute Necrotizing Pancreatitis

Recruiting

• Conditions: Acute Necrotizing Pancreatitis
• Interventions: Diagnostic Test: MRI

• Registration Number: NCT05716633
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

The goal of this study is to investigate the encapsulation of fluid collections in patients with ANP using serial MRI.

The main questions it aims to answer are:

* Evaluating the timing of encapsulation of necrotic fluid collection using serial non-enhanced MRI.

* Identifying the factors that affect the timing of encapsulation of necrotic fluid collections Participants will undergo serial MRI scans (all with the same protocol) performed starting at day 15. Subsequent scans will be performed at 5 days interval till the clinically significant encapsulation (for all the collections in an individual patient) is seen or patients are excluded from the protocol due to intervention.

Detailed Description

Consecutive patients with ANP presenting to the hospital within 2 weeks from the pain onset will be recruited. They will undergo serial non-contrast MRI starting at day 15 and every 5 days thereafter, till complete encapsulation of PFC. Ultrasound evaluation of the collection will be performed on the day of MRI by a radiologist not involved in evaluation of MRI. The site and volume of collection as well as thickness and completeness of the capsule and solid content within the collection will be recorded independently by two radiologists. The timing of clinically significant (\>50% of PFC show capsule) and complete encapsulation will be recorded. The proportion of collections encapsulating in each week after 2nd week of illness will be recorded. The association between timing of encapsulation and clinical/biochemical parameters will be assessed. The correlation between the degree of encapsulation and percentage of solid components will also be documented. Multivariate analysis will be performed to identify factors associated with timing of encapsulation.

Study Timeline

• Study First Submitted: 2023-01-29
• Status Verified: 2023-02
• Study Start: 2023-02-02
• Study First Submitted QC: 2023-02-06
• Last Update Submitted: 2023-02-06
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Acute necrotizing pancreatitis

2. Presentation to hospital within 2 weeks of pain onset

3. Willing to give informed consent

Exclusion Criteria

1. Contraindications to non- enhanced MRI (Claustrophobia, cardiac pacemaker, cochlear implant).
2. Acute on chronic pancreatitis
3. Mechanical ventilation, ionotropic support (precluding safe environment in MRI).
4. Drainage or aspiration of a collection prior to recruitment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute Pancreatitis	MRI	Patients with acute pancreatitis will undergo serial MRI

Primary Outcome Measures

Name	Time	Method
Timing of Encapsulation	1-2 months after initial MRI	MRI scans will be performed

Trial Locations

Locations (1)

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, Punjab, India