Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis

Status:	Recruiting
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - Any
Updated:	3/28/2019
Start Date:	September 2015
End Date:	June 2021
Contact:	B. Joseph Elmunzer, MD
Email:	elmunzer@musc.edu

Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis: The SVI Trial

Background: Pancreatitis is the most frequent complication of endoscopic retrograde
cholangiopancreatography (ERCP), accounting for substantial morbidity, occasional mortality,
and increased health care expenditures. Until recently, the only effective method of
preventing post-ERCP pancreatitis (PEP) had been prophylactic pancreatic stent placement
(PSP), an intervention that is costly, time consuming, technically challenging, and
potentially dangerous. The investigators recently reported the results of a large randomized
controlled trial demonstrating that rectal indomethacin, a non-steroidal anti-inflammatory
drug, reduced the risk of pancreatitis after ERCP in high-risk patients, most of whom (>80%)
had received a pancreatic stent. Secondary analysis of this RCT suggested that subjects who
received indomethacin alone were less likely to develop PEP than those who received a
pancreatic stent alone or the combination of indomethacin and stent, even after adjusting for
underlying differences in subject risk. If indomethacin were to obviate the need for PSP,
major clinical and cost benefits in ERCP practice could be realized.

Objective: To assess whether rectal indomethacin alone is non-inferior to the combination of
rectal indomethacin and prophylactic pancreatic stent placement for preventing post-ERCP
pancreatitis in high-risk cases.

Methods: Comparative effectiveness multi-center non-inferiority trial of rectal indomethacin
alone vs. the combination of rectal indomethacin and prophylactic pancreatic stent placement
for the prevention of post-ERCP pancreatitis in high-risk patients. One thousand four hundred
and thirty subjects at elevated risk for PEP who would normally receive a pancreatic stent
for prophylaxis will be randomized to indomethacin alone or the combination of indomethacin
and PSP. The proportion of patients developing PEP and moderate-severe PEP will be compared.
In addition, the investigators will establish a quality-assured central repository of
biological specimens obtained from study participants, permitting future translational
research elucidating the molecular and genetic mechanisms of PEP, as well as the mechanisms
by which non-steroidal anti-inflammatory drugs prevent this complication.

Inclusion Criteria:

Any patient undergoing ERCP in whom pancreatic stent placement is planned for post-ERCP
pancreatitis prevention, is ≥ 18 years old, who provides informed consent, AND:

Has one of the following:

1. Clinical suspicion of or known sphincter of Oddi dysfunction

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

3. Pancreatic sphincterotomy

4. Pre-cut (access) sphincterotomy (freehand pre-cut and septotomy)

5. Difficult cannulation: cannulation duration ≥ 6 minutes (starting at time of initial
papillary engagement with at least 25% of the time in contact with the papilla) AND/OR
≥ 6 cannulation attempts (defined as sustained contact with papilla lasting at least 1
second).

6. Short-duration (≤ 1 min) balloon dilation of an intact biliary sphincter.

Or has at least 2 of the following:

7. Age < 50 years old & female gender

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

9. ≥3 pancreatic injections

10. Pancreatic acinarization

11. Pancreatic brush cytology

Exclusion Criteria:

1. Ampullectomy

2. Cases in which a pancreatic stent must be placed for therapeutic intent

3. Unwillingness or inability to consent for the study

4. Pregnancy

5. Breast feeding mother

6. Standard contraindications to ERCP

7. Allergy to Aspirin or NSAIDs

8. Known renal failure (Cr > 1.4 mg/dl)

9. Ongoing or recent (within 2 weeks) hospitalization for gastrointestinal hemorrhage

10. Ongoing or recent (within 1 week) hospitalization for acute pancreatitis

11. Known chronic calcific pancreatitis

12. Pancreatic head malignancy

13. Procedure performed on major papilla/ventral pancreatic duct in patient with pancreas
divisum (no manipulation of minor papilla)

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

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

16. Anticipated inability to follow protocol

17. Absence of rectum

We found this trial at

sites

Virginia Mason Medical Center

Seattle, Washington 98101

(888) 862-2737