Tracking ENcapsulation of Pancreatic Collections in Acute Necrotizing Pancreatitis

February 6, 2023 updated by: Pankaj Gupta, Postgraduate Institute of Medical Education and Research, Chandigarh

Tracking the ENcapsulation of Pancreatic Collections in Acute Necrotizing Pancreatitis. A Serial MRI Based Prospective Study (MRI-ENCAP Study)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

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 Locations

  • India
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Recruiting
        • Post Graduate Institute of Medical Education and Research
        • Contact:
          • Pankaj Gupta

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  1. Acute necrotizing pancreatitis
  2. Presentation to hospital within 2 weeks of pain onset

2. 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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute Pancreatitis
Patients with acute pancreatitis will undergo serial MRI
Diagnostic test: MRI
Serial MRI scans will be performed starting at day 15 from date of pain. Subsequent scans will be performed at 5 days interval till the clinically significant encapsulation (for all the collections in an individual patient) is seen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timing of Encapsulation
Time Frame: 1-2 months after initial MRI
MRI scans will be performed
1-2 months after initial MRI

Collaborators and Investigators

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

Sponsor

Postgraduate Institute of Medical Education and Research, Chandigarh

Investigators

  • Principal Investigator: Pankaj Gupta, PGIMER, Chandigarh

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)

February 2, 2023

Primary Completion (ANTICIPATED)

December 31, 2025

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

January 29, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32055

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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