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Status unknownNCT03259880Updated Aug 24, 2017

Searching the Best Prognostic Factor in Out Come Evaluation in Patients With Acute Pancreatitis Admitted at Assiut University Hospitals

An observational study in Acute Pancreatitis, sponsored by Fady Refaat Edwar Nasrallah. Status unknown. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-08-24.

Sponsored by Fady Refaat Edwar Nasrallah · Observational

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
16 Years to 80 Years
Sex
All
01

Study summary

Acute pancreatitis (AP) is rapid-onset inflammation of the pancreas that varies in severity from a self-limiting mild illness to rapidly progressive multiple organ failure. Statistics suggest that 10-20% of patients with AP develop severe AP (SAP),1 which usually has an unfavourable disease progression and is associated with a poor prognosis.

The two most common and important causes of acute pancreatitis are gallstones (40-70%) and alcohol (25-35%) Gallstone pancreatitis is usually due to an obstructing stone in the pancreatic duct near the sphincter of Oddi . In alcohol-related pancreatitis, it is believed that the acinar cells of the pancreas are susceptible to damage by ethanol and underlie the etiology of the disease . Another common cause, iatrogenic pancreatitis, may occur after endoscopic retrograde cholangiopancreatography (ERCP) in up to 5% of patients. Other etiologies of acute pancreatitis include medications, infections, trauma, hereditary, hypertriglyceridemia and autoimmune disease.

Read the detailed description

Acute pancreatitis (AP) is rapid-onset inflammation of the pancreas that varies in severity from a self-limiting mild illness to rapidly progressive multiple organ failure. Statistics suggest that 10-20% of patients with AP develop severe AP (SAP),1 which usually has an unfavourable disease progression and is associated with a poor prognosis. (Banks PA, Bollen,et al.).

The two most common and important causes of acute pancreatitis are gallstones (40-70%) and alcohol (25-35%) (Tenner S et al., 2014) Gallstone pancreatitis is usually due to an obstructing stone in the pancreatic duct near the sphincter of Oddi ( Bhatia M et al .,2005). In alcohol-related pancreatitis, it is believed that the acinar cells of the pancreas are susceptible to damage by ethanol and underlie the etiology of the disease ( Tonsi AF et al ., 2009). Another common cause, iatrogenic pancreatitis, may occur after endoscopic retrograde cholangiopancreatography (ERCP) in up to 5% of patients. Other etiologies of acute pancreatitis include medications, infections, trauma, hereditary, hypertriglyceridemia and autoimmune disease.

According to the American College of Gastroenterology, a patient must have two of the following three features present to make a diagnosis of acute pancreatitis The diagnostic criteria used for acute pancreatitis includes:

  1. Clinical criteria - history of pain in abdomen radiating to the back and relieved on bending forward associated with tenderness/guarding in the upper abdomen.
  2. Radiographic evidence - Computed Tomography findings suggestive of acute pancreatitis such as pancreatic edema, pancreatic necrosis, peripancreatic fluid collections
  3. Biochemical - Serum amylase concentration greater than 180 Somogyii units (by the Somogyii method).
02

Conditions studied

  • Acute Pancreatitis

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Keywords

  • evaluation
03

Who can participate

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

Study population

Evaluation of the best prognostic parameter in patients with acute pancreatitis

Inclusion criteria

  • 100 patients with acute pancreatitis admitted at Assiut university hospital and the diagnosis of acute pancreatitis is confirmed if at least two of the following three features present:

    1. abdominal pain characteristic of acute pancreatitis.
    2. serum amylase and/or lipase greater than 3 times the upper limit of normal .
    3. radiographically demonstrated acute pancreatitis on CT scan or abdominal ultrasound.

Exclusion criteria

Exclusion Criteria:

  1. Patients are excluded from the study if they do not meet the criteria for acute pancreatitis
  2. Patients who are under the age of 16.
  3. Patients with chronic pancreatitis.
  4. Patients with recurrent acute pancreatitis
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. evaluation of the prognostic value of neutrophil _lymphocyte ratio in cbc in patients with acute pancreatitis admitted at assiut university hospitals.

    evaluation of the prognostic value neutrophil lymphocyte ratio in patient with acute pancreatitis

    Time frame: one year

  2. evaluation of the prognostic value of LDH in patients with acute pancreatitis admitted at assiut university hospitals.

    evaluation of the prognostic value of LDH ratio in patient with acute pancreatitis

    Time frame: one year

  3. evaluation of the prognostic value of urine analysis in patients with acute pancreatitis admitted at assiut university hospitals.

    evaluation of the prognostic value of urine analysis ratio in patient with acute pancreatitis

    Time frame: one year

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03259880
Lead sponsor
Fady Refaat Edwar Nasrallah
Collaborators
Assiut University
Responsible party
Fady Refaat Edwar Nasrallah (internal medicine resident,Assiut University hospital, Assiut University) — Sponsor-investigator
First posted
Aug 24, 2017
Start date
Sep 1, 2017 (estimated)
Primary completion
Sep 1, 2018 (estimated)
Completion
Sep 1, 2018 (estimated)
Last update
Aug 24, 2017

Oversight

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

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This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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