Tracking ENcapsulation of Pancreatic Collections in Acute Necrotizing Pancreatitis

NCT ID: NCT05716633

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-02

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Acute Necrotizing Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute Pancreatitis

Patients with acute pancreatitis will undergo serial MRI

MRI

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Pankaj Gupta

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pankaj Gupta

Role: PRINCIPAL_INVESTIGATOR

PGIMER, CHANDIGARH

Locations

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Post Graduate Institute of Medical Education and Research

Chandigarh, Punjab, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Pankaj Gupta

Role: CONTACT

0172-2756508

Facility Contacts

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Pankaj Gupta

Role: primary

References

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Baron TH, DiMaio CJ, Wang AY, Morgan KA. American Gastroenterological Association Clinical Practice Update: Management of Pancreatic Necrosis. Gastroenterology. 2020 Jan;158(1):67-75.e1. doi: 10.1053/j.gastro.2019.07.064. Epub 2019 Aug 31.

Reference Type BACKGROUND
PMID: 31479658 (View on PubMed)

Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

Reference Type BACKGROUND
PMID: 23100216 (View on PubMed)

ASGE Standards of Practice Committee; Muthusamy VR, Chandrasekhara V, Acosta RD, Bruining DH, Chathadi KV, Eloubeidi MA, Faulx AL, Fonkalsrud L, Gurudu SR, Khashab MA, Kothari S, Lightdale JR, Pasha SF, Saltzman JR, Shaukat A, Wang A, Yang J, Cash BD, DeWitt JM. The role of endoscopy in the diagnosis and treatment of inflammatory pancreatic fluid collections. Gastrointest Endosc. 2016 Mar;83(3):481-8. doi: 10.1016/j.gie.2015.11.027. Epub 2016 Jan 13. No abstract available.

Reference Type BACKGROUND
PMID: 26796695 (View on PubMed)

Trikudanathan G, Tawfik P, Amateau SK, Munigala S, Arain M, Attam R, Beilman G, Flanagan S, Freeman ML, Mallery S. Early (<4 Weeks) Versus Standard (>/= 4 Weeks) Endoscopically Centered Step-Up Interventions for Necrotizing Pancreatitis. Am J Gastroenterol. 2018 Oct;113(10):1550-1558. doi: 10.1038/s41395-018-0232-3. Epub 2018 Oct 2.

Reference Type BACKGROUND
PMID: 30279466 (View on PubMed)

Oblizajek N, Takahashi N, Agayeva S, Bazerbachi F, Chandrasekhara V, Levy M, Storm A, Baron T, Chari S, Gleeson FC, Pearson R, Petersen BT, Vege SS, Lennon R, Topazian M, Abu Dayyeh BK. Outcomes of early endoscopic intervention for pancreatic necrotic collections: a matched case-control study. Gastrointest Endosc. 2020 Jun;91(6):1303-1309. doi: 10.1016/j.gie.2020.01.017. Epub 2020 Jan 18.

Reference Type BACKGROUND
PMID: 31958461 (View on PubMed)

van Grinsven J, van Brunschot S, van Baal MC, Besselink MG, Fockens P, van Goor H, van Santvoort HC, Bollen TL; Dutch Pancreatitis Study Group. Natural History of Gas Configurations and Encapsulation in Necrotic Collections During Necrotizing Pancreatitis. J Gastrointest Surg. 2018 Sep;22(9):1557-1564. doi: 10.1007/s11605-018-3792-z. Epub 2018 May 11.

Reference Type BACKGROUND
PMID: 29752684 (View on PubMed)

Chantarojanasiri T, Yamamoto N, Nakai Y, Saito T, Saito K, Hakuta R, Ishigaki K, Takeda T, Uchino R, Takahara N, Mizuno S, Kogure H, Matsubara S, Tada M, Isayama H, Koike K. Comparison of early and delayed EUS-guided drainage of pancreatic fluid collection. Endosc Int Open. 2018 Dec;6(12):E1398-E1405. doi: 10.1055/a-0751-2698. Epub 2018 Nov 23.

Reference Type BACKGROUND
PMID: 30505932 (View on PubMed)

Rana SS, Sharma R, Kishore K, Dhalaria L, Gupta R. Safety and Efficacy of Early (<4 Weeks of Illness) Endoscopic Transmural Drainage of Post-acute Pancreatic Necrosis Predominantly Located in the Body of the Pancreas. J Gastrointest Surg. 2021 Sep;25(9):2328-2335. doi: 10.1007/s11605-021-04945-y. Epub 2021 Feb 5.

Reference Type BACKGROUND
PMID: 33547585 (View on PubMed)

Rana SS, Verma S, Kang M, Gorsi U, Sharma R, Gupta R. Comparison of endoscopic versus percutaneous drainage of symptomatic pancreatic necrosis in the early (< 4 weeks) phase of illness. Endosc Ultrasound. 2020 Nov-Dec;9(6):402-409. doi: 10.4103/eus.eus_65_20.

Reference Type BACKGROUND
PMID: 33318376 (View on PubMed)

Other Identifiers

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32055

Identifier Type: -

Identifier Source: org_study_id

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