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CompletedNCT03411629Updated Sep 24, 2019

Significance of Collections Around Colon in Patients With Acute Necrotizing Pancreatitis

An observational study in Acute Necrotizing Pancreatitis, sponsored by Sanjay Gandhi Postgraduate Institute of Medical Sciences. Completed at 1 site in India. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-09-24.

Sponsored by Sanjay Gandhi Postgraduate Institute of Medical Sciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
44
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Acute Necrotizing Pancreatitis

Keywords

  • Necrotizing Pancreatitis
  • Critically ill
  • Mortality
03

In context

Pancreatitis, Acute Necrotizing

74 studies on the registry are indexed under Pancreatitis, Acute Necrotizing; 19 are open to participants now.

This study's enrollment of 44 is below the median of 100 across 25 observational studies indexed under Pancreatitis, Acute Necrotizing.

Browse Pancreatitis, Acute Necrotizing studies →

Lead sponsor

Sanjay Gandhi Postgraduate Institute of Medical Sciences is the lead sponsor of 38 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years
  • Pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
44 participants (actual)
Target follow-up
4 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  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..

    Time frame: Up to 6 weeks of the acute pancreatitis

07

Study locations

1 site
  • Department of Critical Care Medicine, SGPGIMS
    Lucknow, Uttar Pradesh 226014, India
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Apr 2019, 14 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2018
First posted
Jan 26, 2018
StartActual
Jan 12, 2018
Primary completionActual
Apr 11, 2019
CompletionActual
May 18, 2019
Last update
Sep 24, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03411629
Lead sponsor
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Responsible party
Mohan Gurjar (Additional Professor, Sanjay Gandhi Postgraduate Institute of Medical Sciences) — Principal investigator
First posted
Jan 26, 2018
Start date
Jan 12, 2018
Primary completion
Apr 11, 2019
Completion
May 18, 2019
Last update
Sep 24, 2019

Study contacts

Mohan Gurjar, MD, PDCC
principal investigator · Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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