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Acute Necrotizing PancreatitisNCT03411629

Significance of Collections Around Colon in Patients With Acute Necrotizing Pancreatitis

An observational study of Acute Necrotizing Pancreatitis, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Acute pancreatitis is an inflammatory process which causes a local and systemic inflammatory response syndrome (SIRS). Although the majority of patients have a mild disease course, around 20% will develop moderate or severe pancreatitis, with necrosis of the (peri) pancreatic tissue and/or multiple-organ failure. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Necrotizing Pancreatitis
How many people
44 participants
Where
1 siteIndia
Study dates
12 Jan 2018to 18 May 2019
How long will I take part?
4 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All adult (≥18 years) ICU patients who had acute necrotizing pancreatitis.

Who may be able to join

  • All adult (≥18 years) ICU patients who had acute necrotizing pancreatitis will be considered.

Who cannot join

  • Age <18 years
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

India1 site
  • Department of Critical Care Medicine, SGPGIMS

    Lucknow, Uttar Pradesh, 226014

Other trials in India

About this study

Official title: Significance of Collections Around Colon in Patients With Acute Necrotizing Pancreatitis: a Prospective Study

Acute pancreatitis is an inflammatory process which causes a local and systemic inflammatory response syndrome (SIRS). Although the majority of patients have a mild disease course, around 20% will develop moderate or severe pancreatitis, with necrosis of the (peri) pancreatic tissue and/or multiple-organ failure. Previous studies have correlated colonic involvement as a prognostic marker in acute pancreatitis. It is well known that translocation of the colonic flora may significantly influence the clinical course of patients with acute pancreatitis. The correlation between collection(s) around colon in CT finding and clinical outcomes has not been studied in necrotizing pancreatitis. In current study, the investigators will do a prospective observational study correlating collection(s) around the colon and clinical course of patients in acute necrotizing pancreatitis.

Read the detailed description

Introduction and rationale of the study:

Acute pancreatitis is the leading gastrointestinal cause of hospitalization in the US, with 270,000 admissions annually. Acute pancreatitis is an inflammatory process which causes a local and systemic inflammatory response syndrome (SIRS). Although the majority of patients have a mild disease course, around 20% will develop moderate or severe pancreatitis, with necrosis of the (peri) pancreatic tissue and/or multiple-organ failure About 5-10% of patients develop necrosis of the pancreatic parenchyma, the peripancreatic tissue or both. A collection containing variable amounts of both fluid and necrosis associated with necrotizing pancreatitis; the necrosis can involve the pancreatic parenchyma and/or the peri- pancreatic tissues. A mature, encapsulated collection of pancreatic and/or peri- pancreatic necrosis with well defined inflammatory wall is walled off necrosis (WON). It usually occurs >4 weeks after onset of necrotizing pancreatitis.

Colonic involvement may predict disease severity and outcome. Clinical features may appear late in the course. Colonic complications occur in 1% patients with acute pancreatitis with 6-40% occurring with necrotizing pancreatitis. Correlation between colonic wall thickening at CT and the clinical course has already been established in non-necrotizing pancreatitis. Colonic necrosis is an adverse prognostic factor in pancreatic necrosis. Extension of necrosis towards the transverse colon and the splenic flexure were seen most commonly observed.

Previous studies have correlated colonic involvement as a prognostic marker in acute pancreatitis. It is well known that translocation of the colonic flora may significantly influence the clinical course of patients with acute pancreatitis. The correlation between collection(s) around colon in CT finding and clinical outcomes has not been studied in necrotizing pancreatitis.

Work plan methodology:

This will be a prospective, observational study, to be conducted in 20 bed ICU of department of Critical Care Medicine, Sanjay Gandhi Institute of Postgraduate and Medical Sciences, Lucknow.

All adult (≥18 years) ICU patients who had acute necrotizing pancreatitis will be considered. Demographic and clinical characteristics of all ICU patients who fulfill inclusion criteria will be collected along with relevant laboratory tests done for patient management routinely. ICU prognostication scores, i.e., Acute Physiologic and Chronic Health Evaluation (APACHE) II score and Sequential Organ Failure Assessment (SOFA) score will also be recorded. The investigators will review all available computed tomography scans (CT Scans) of abdomen, from 2nd week to 6th week of pancreatitis, which will be done as per treating clinicians during patient ICU stay.

Collection around colon is classified as: 1. No pericolonic collection; 2. Less than 90 degree encasement of colon; 3. In between 90-180 degree; 4. More than 180 degree encasement of colon. Other intra-abdominal collection will also be noted along with mesocolon.

Clinical course will be followed till ICU discharge in terms of need for drain and surgery, intra-abdominal infection, and survival at discharge.

Statistical analysis: Descriptive analysis will be done and data will be presented as mean or median.

Intervention: None. Waiver of consent has been granted by the Institute Ethics Committee (IEC).

Keywords
Necrotizing Pancreatitis, Critically ill, Mortality
Medical subject headings
Pancreatitis, Acute Necrotizing, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlating collection(s) around the colon and clinical course of patients in acute necrotizing pancreatitis.

    To study CT finding of collection(s) around colon in patients with acute necrotizing pancreatitis and its association with clinical course i.e. intra-abdominal infection, need of drain/surgery and survival at ICU discharge..

    Measured: Up to 6 weeks of the acute pancreatitis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2018
  2. Study start12 Jan 2018
  3. Primary completion11 Apr 2019
  4. Study completion18 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
44 participants (actual)
Target duration
4 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03411629
Sponsor's protocol ID
2017-235-IP-EXP
Status last verified
Sep 2019
First submitted
13 Jan 2018
Last updated
24 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Necrotizing Pancreatitis, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlating collection(s) around the colon and clinical course of patients in acute necrotizing pancreatitis. (time frame: Up to 6 weeks of the acute pancreatitis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.

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