NCT05716633

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

February 2, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2.9 years

First QC Date

January 29, 2023

Last Update Submit

February 6, 2023

Conditions

Acute Necrotizing Pancreatitis

Keywords

Acute Pancreatitis,Necrotic Collections,Walled off Necrosis

Outcome Measures

Primary Outcomes (1)

  • Timing of Encapsulation

    MRI scans will be performed

    1-2 months after initial MRI

Study Arms (1)

Acute Pancreatitis

Patients with acute pancreatitis will undergo serial MRI

Diagnostic Test: MRI

Interventions

MRIDIAGNOSTIC_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.

Acute Pancreatitis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Acute necrotizing pancreatitis
  • Presentation to hospital within 2 weeks of pain onset
  • \. Willing to give informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, Punjab, 160012, India

RECRUITING

Related Publications (9)

  • 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.

    PMID: 31479658BACKGROUND

  • 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.

    PMID: 23100216BACKGROUND

  • 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.

    PMID: 26796695BACKGROUND

  • 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.

    PMID: 30279466BACKGROUND

  • 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.

    PMID: 31958461BACKGROUND

  • 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.

    PMID: 29752684BACKGROUND

  • 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.

    PMID: 30505932BACKGROUND

  • 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.

    PMID: 33547585BACKGROUND

  • 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.

    PMID: 33318376BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Acute NecrotizingPancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Pankaj Gupta

    PGIMER, CHANDIGARH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pankaj Gupta

CONTACT

0172-2756508pankajgupta959@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 29, 2023

First Posted

February 8, 2023

Study Start

February 2, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)