Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomised Controlled Trial On The Effects Of Parenteral Fish Oil Emulsion In Patients With Severe Acute Pancreatitis
Brief Summary: The incidence of acute pancreatitis in UK has risen sharply over the past 40 years. Recent reports suggest that 56.5 per 100 000 of the population will suffer from AP annually; this figure is more than double the highest previous estimated incidence. In the majority of patients the condition is mild, but about 25% of patients suffer a severe attack and between 30 and 50% of these patients dies. The usual cause of death is multiple organ failure secondary to systemic leukocyte activation (mainly neutrophils), accompanied by the systemic inflammatory response syndrome (SIRS).

Studies with omega-3 fish oil have shown to control inflammatory process and improve the outcome especially in hyperinflammatory conditions.

This research will look at the effects of supplementing omega-3 fish oil to patients with severe acute pancreatitis (severe inflammation of the pancreas).

Patients with severe acute pancreatitis will be prospectively and blindly randomised into either a study group who will receive (Lipidem, lipid emulsion contains essential fatty acids and omega-3 fish oil) or a control group that will receive (Lipofundin, lipid emulsion contains only essential fatty acids and no omega-3 fish oil). Normal and standard clinical care will be provided to all patients as per the national management guidelines. Each patient will receive either Lipidem or Lipofundin emulsions daily until they are deemed fit for discharge by their own medical team or for a maximum of SEVEN days.

The main aim of this study is to examine whether lipid emulsions enriched with omega-3 fish oil could improve the clinical outcome in patients with severe acute pancreatitis.


Options:
A: Inclusion Criteria:

Conscious patients between age of 18-90 admitted to the Leicester General hospital with severe acute pancreatitis proven by:

1. compatible clinical features (abdominal pain with or without vomiting);
2. associated with elevated serum amylase levels (≥3 normal value) (≥300 iu/l);
3. one or more of the severity criteria as outlined in the Atlanta severity criteria or modified glasgow acute pancreatitis severity score ≥3

Exclusion Criteria:

* Patients unconscious or unable to consent.
* Patients under 18 years old or above 90 years old
* Hypersensitivity to fish, egg or soy protein or other active substances of the TPN.
* Uncontrolled hyperlipidaemia
* Severe primary blood coagulation disorder
* Acute pancreatitis accompanied with hyperlipidaemia
* Ketoacidosis
* Acute thromboembolic disease
* Severe liver failure
* Acute phase of myocardial infarction or stroke
* Pregnancy and lactation
* Severe renal failure without access to haemofiltration or dialysis
B: Inclusion Criteria:

Included patients are those undergoing ERCP and have one of the following:

1. Clinical suspicion of sphincter of Oddi dysfunction
2. History of post-ERCP pancreatitis (at least one episode)
3. Pancreatic sphincterotomy
4. Pre-cut (access) sphincterotomy
5. \> 8 cannulation attempts
6. Pneumatic dilation of intact biliary sphincter
7. Ampullectomy

or at least 2 of the following:

1. Age \< 50 years old \& female gender
2. History of recurrent pancreatitis (at least 2 episodes)
3. ≥3 pancreatic injections, with at least one injection to tail
4. Pancreatic acinarization
5. Pancreatic brush cytology

Exclusion Criteria:

1. Unwillingness or inability to consent for the study
2. Age \< 18 years
3. Intrauterine pregnancy
4. Breast feeding mother
5. Standard contraindications to ERCP
6. Allergy to Aspirin or NSAIDs
7. Renal failure (Cr \> 1.4)
8. Active or recent (within 4 weeks) gastrointestinal hemorrhage
9. Acute pancreatitis (lipase peak) within 72 hours
10. Known chronic calcific pancreatitis
11. Pancreatic head malignancy
12. Procedure performed on major papilla/ventral panc duct in pt with pancreas divisum (no manipulation of minor papilla)
13. ERCP for biliary stent removal or exchange without anticipated pancreatogram
14. Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
15. Anticipated inability to follow protocol
16. Endoscopist discretion: low risk (\<10%) of post-ERCP pancreatitis
C: Inclusion Criteria:

1. Predicted Severe Acute Pancreatitis
2. Enrollment within 72 hours of diagnosis
3. Ability to give informed consent
4. Age \>17 years

Exclusion Criteria:

1. Moderate or severe congestive heart failure
2. History of seizure disorder or demyelinating disease
3. Nursing mothers
4. Pregnancy
5. History of prior tuberculosis or risk factors for tuberculosis
6. Evidence of immunosuppression (malignancy, chronic renal failure, chemotherapy within 60 days, ongoing steroid treatment\*, and HIV)- (\*the exception of prednisone use will be allowed to participate).
7. Evidence of chronic pancreatitis from history and examination (however, "acute on chronic pancreatitis" diagnosis is allowed)
8. Evidence of active or pending hemorrhage.
9. Paralytic ileus with vomiting
D: Inclusion Criteria:

* Admitted to hospital within 72 h of the onset of pain.
* Plasma amylase concentration more than three times the upper limit of the normal range and/or CT findings compatible with AP.
* Organ failure and \<48h of the onset of the first organ failure

Exclusion Criteria:

* HIV / B- or C hepatitis infection
* Pregnancy or breast feeding
* Active bleeding
* Increased risk of bleeding (thrombocytes \<30x10E9/L or INR\>3.0
* Gastrointestinal bleeding within 6 weeks or intracranial stroke within 3 months before the study
* Intravenous contrast extravasation or other signs (fresh hematoma) suggesting active hemorrhage within the pancreas or in the peripancreatic area on admission CT scan
* Use of antithrombin III within 12 h
* Use of acetylsalicylic acid or glycoprotein IIB/IA antagonist within 7 days / Thrombolytic therapy within 3 days
* Surgery requiring general or spinal anaesthesia within 12 h
* Previous pancreatic surgery
* Application of an epidural catheter within 48 h

Answer: A