Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 11:54 AM
Study NCT ID:
NCT05716633
Status:
RECRUITING
Last Update Posted:
2023-02-08
First Post:
2023-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tracking ENcapsulation of Pancreatic Collections in Acute Necrotizing Pancreatitis
Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Organization:
Study Overview
Official Title:
Tracking the ENcapsulation of Pancreatic Collections in Acute Necrotizing Pancreatitis. A Serial MRI Based Prospective Study (MRI-ENCAP Study)
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: