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Tracking ENcapsulation of Pancreatic Collections in Acute Necrotizing Pancreatitis

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ClinicalTrials.gov Identifier: NCT05716633
Recruitment Status : Recruiting
First Posted : February 8, 2023
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Pankaj Gupta, Post Graduate Institute of Medical Education and Research, Chandigarh

Study Description
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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.

Condition or disease Intervention/treatment
Acute Necrotizing Pancreatitis Diagnostic Test: MRI

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Tracking the ENcapsulation of Pancreatic Collections in Acute Necrotizing Pancreatitis. A Serial MRI Based Prospective Study (MRI-ENCAP Study)
Actual Study Start Date : February 2, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Timing of Encapsulation [ Time Frame: 1-2 months after initial MRI ]
    MRI scans will be performed


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05716633


Contacts
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Contact: Pankaj Gupta 0172-2756508 pankajgupta959@gmail.com

Locations
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India
Post Graduate Institute of Medical Education and Research Recruiting
Chandigarh, Punjab, India, 160012
Contact: Pankaj Gupta         
Sponsors and Collaborators
Post Graduate Institute of Medical Education and Research, Chandigarh
Investigators
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Principal Investigator: Pankaj Gupta PGIMER, CHANDIGARH
More Information
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Publications:

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Responsible Party: Pankaj Gupta, Associate Professor, Post Graduate Institute of Medical Education and Research, Chandigarh
ClinicalTrials.gov Identifier: NCT05716633    
Other Study ID Numbers: 32055
First Posted: February 8, 2023    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pankaj Gupta, Post Graduate Institute of Medical Education and Research, Chandigarh:
Acute Pancreatitis,Necrotic Collections,Walled off Necrosis
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Digestive System Diseases