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.
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
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).
- Conditions
- Acute Necrotizing Pancreatitis
- 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.
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.
- First posted26 Jan 2018
- Study start12 Jan 2018
- Primary completion11 Apr 2019
- Study completion18 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Necrotizing PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohan Gurjar, Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Investigators
- Mohan Gurjar, MD, PDCC, Principal investigator, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Collections Around Colon in Patients With Acute Necrotizing Pancreatitis: a Prospective Study
- ClinicalTrials.gov ID
- NCT03411629
- Acronym / sponsor ID
- 2017-235-IP-EXP
- Conditions
- Acute Necrotizing Pancreatitis
- Keywords
- Necrotizing Pancreatitis, Critically ill, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical SciencesOther government
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 18 May 2019 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult (≥18 years) ICU patients who had acute necrotizing pancreatitis.
Key inclusion criteria (1 listed)
- All adult (≥18 years) ICU patients who had acute necrotizing pancreatitis will be considered.
Key exclusion criteria (2 listed)
- Age <18 years
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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..
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohan Gurjar, MD, PDCC principal investigator
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
1 site in 1 country: see every site and its status.
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.