Clinical trial NCT03411629: Significance of Collections Around Colon in Patients With Acute Necrotizing Pancreatitis
Official title: Significance of Collections Around Colon in Patients With Acute Necrotizing Pancreatitis: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Necrotizing Pancreatitis
Keywords: Necrotizing Pancreatitis
Critically ill
Mortality
Lead sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2018-01-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult (≥18 years) ICU patients who had acute necrotizing pancreatitis.

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Age \<18 years
* Pregnancy

Primary outcomes:
measure: Correlating collection(s) around the colon and clinical course of patients in acute necrotizing pancreatitis.
timeFrame: Up to 6 weeks of the acute pancreatitis
Secondary outcomes:
Other outcomes:
Locations:
city: Lucknow
country: India
facility: Department of Critical Care Medicine, SGPGIMS
state: Uttar Pradesh
Study officials:
affiliation: Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
name: Mohan Gurjar, MD, PDCC
role: PRINCIPAL_INVESTIGATOR
References: