Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Randomized, Controlled Trial of Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients.
Brief Summary: Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct.

Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.


Options:
A: Inclusion Criteria:

* All patients referred for ERCP who have an intact naïve papilla are considered for inclusion

Exclusion Criteria:

* Age \<18yrs
* Acute illness (hypotension: BP\<90mmHg, hypoxia: O2 \<95%, haemodynamic instability)
* Inability or refusal to give informed consent.
* Patients with previous sphincterotomy
* Pancreatic or ampullary cancer are excluded as post-ERCP pancreatitis (PEP) is very uncommon in these subgroups and tumour-related anatomical variation may alter cannulation technique.

(consider substratify results for this subgroup, but exclude if duodenal stenosis precludes an attempt on the papilla)

* Patients with surgically altered anatomy (Bilroth II gastrectomy and Roux en Y anastomosis) are excluded as cannulation technique is fundamentally different from that in normal anatomy.
B: Inclusion Criteria:

* high-risk patients for post-ERCP pancreatitis

Exclusion Criteria:

* age \< 18 years
* allargy to the contrast medium
* previous biliary or gastric surgery
* neoplastic patients
* previous biliary or pancreatic sphincterotomy
C: Inclusion Criteria:

1 Subjects who are undergoing endoscopic retrograde cholangiopancreatography (ERCP)

* Age \> 18 years
* Non-pregnant
* Non-prisoners
* Subjects who can sign informed consent
* Serum Creatinine \< 1.2 milligrams/deciliter (mg/dL)
* Subjects without renal failure (acute or chronic)
* Subjects without congestive heart failure (ejection fraction \< 40%)
* Subjects without cirrhosis of the liver
* Subjects without allergy to aspirin or non-steroidal anti-inflammatory drugs (NSAIDS)
* Subjects not on non-steroidal anti-inflammatory drugs NSAIDS prior to enrollment

Exclusion Criteria:

* Subjects who are not undergoing ERCP
* Age \< 18 years
* Pregnancy
* Prisoners
* Subjects lacking the capacity to consent for themselves
* Serum Creatinine \> 1.2 milligrams/deciliter (mg/dL)
* Subjects with renal failure (acute and chronic)
* Subjects with congestive heart failure (ejection fraction \< 40%)
* Subjects with cirrhosis of the liver
* Subjects with allergy to aspirin or non-steroidal anti-inflammatory drugs (NSAIDS)
* Subjects with gastrointestinal hemorrhage
* Subjects on chronic non-steroidal anti-inflammatory drugs NSAIDS
* Subjects with acute pancreatitis the day of their procedure (CITE 1-3)(APPENDIX 1)
D: 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

Answer: D