Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis

Status:	Completed
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - Any
Updated:	10/26/2018
Start Date:	July 2013
End Date:	October 2018

Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients: Searching for the Optimal Dose. A Prospective, Randomized Trial

It is now established that indomethacin, a non-steroidal anti-inflammatory drug, at a dose of
100 mg, is effective in reducing the frequency and severity of pancreatitis (inflammation of
the pancreas) after endoscopic retrograde cholangiopancreatography (ERCP) in high risk
patients. However, the optimal dose required is not known. The purpose of this study is to
determine whether a dose of 200 mg, administered as rectal suppositories, is more effective
than the standard dose of 100 mg. An ERCP procedure is a scope procedure where a lighted tube
with a camera is passed down the patient's throat and allows for evaluation of the bile duct
and/or pancreatic duct. The most common side effect of this procedure is post-ERCP
pancreatitis, or swelling of the pancreas. Some patients are at higher risk for this
complication than others. Our hypothesis is to compare the efficacy of these two dose
regimens (100 mg vs 200 mg) of prophylactic rectally-administered indomethacin on the
frequency and severity of post-ERCP pancreatitis in high-risk patients.

After obtaining informed consent, subjects will undergo ERCP per clinical protocol. All
procedure-related clinical decisions and interventions will be dictated by the performing
physician as he or she sees fit. At the end of the procedure, it will be determined by the
endoscopist and research coordinator whether the patient meets inclusion criteria. If
inclusion criteria are met, subjects will be randomized by concealed allocation to receive
either 100mg or 150mg indomethacin, in the form of two or three 50mg rectal suppositories.
Those patients who are randomized to receive the 100mg dose will receive an additional
glycerin suppository. Four hours later, those patients who were randomized to the high-dose
group will then receive an additional 50mg suppository while in the recovery area. At this
same time point, subjects who were randomized to the standard-dose group, will receive a
glycerin suppository in the recovery area. All participating patients will receive a total of
4 suppositories.

Inclusion Criteria:

Included patients are those undergoing ERCP and have:

one of the following:

1. Clinical suspicion of sphincter of Oddi dysfunction (type I or II)

2. History of post-ERCP pancreatitis (at least one episode)

3. Pancreatic sphincterotomy

4. Pre-cut (access) sphincterotomy

5. >8 cannulation attempts of any sphincter

6. Pneumatic dilation of intact biliary sphincter

7. Ampullectomy 8.) Assessment for post-sphincterotomy stenosis

OR at least 2 of the following:

1. Age <50 years old and female gender

2. History of recurrent pancreatitis (at least 2 episodes)

3. > or = to 3 pancreatic injections, with at least 1 injection to tail

4. Pancreatic acinarization (excluding ventral pancreas of pancreas divisum)

5. Pancreatic brush cytology -

Exclusion Criteria:

1. Unwillingness or inability to consent for the study

2. Age < 18 years

3. Intrauterine pregnancy

4. Breastfeeding mother

5. Standard contraindications to ERCP

6. Allergy/hypersensitivity to aspirin or NSAIDs

7. Received NSAIDs in prior 7 days (aspirin 325mg or less ok)

8. Renal failure (Cr >1.4)

9. Active or recurrent (within 4 weeks) gastrointestinal hemorrhage

10. Acute pancreatitis (lipase peak) within 72 hours

11. Known chronic calcific pancreatitis

12. Pancreatic head mass

13. Procedure performed on major papilla/ventral pancreatic duct in patient with pancreas
divisum (dorsal duct not attempted on injected)

14. ERCP for biliary stent removal or exchange without anticipated pancreatogram

15. Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy
without anticipated pancreatogram

16. Anticipated inability to follow protocol

17. Known active cardiovascular or cerebrovascular disease -

We found this trial at

sites

Methodist Dallas Medical Center

Dallas, Texas 75203

Principal Investigator: Paul Tarnasky, MD

from

Dallas, TX