Rectal Indomethacin for Prevention of Post-ERCP Pancreatitis

Patient-level data from a multi-center, randomized, double-blind, placebo-controlled 2-arm trial (n = 602) of rectal indomethacin (100 mg) versus placebo to prevent post-ERCP pancreatitis in high-risk patients, as reported by Elmunzer, Higgins, et al. (2012) in the New England Journal of Medicine.

This dataset was originally collected, cleaned, reformatted, and released for public teaching and research use by Dr. Peter D. R. Higgins in the medicaldata R package as indo_rct. The version shipped here is redistributed in support of the worked examples in this package. The variable definitions below follow medicaldata; note that a few columns are stored as numeric (rather than factor) in this copy. Users who need the authoritative copy or accompanying documentation should consult medicaldata.

Format

A data frame with 602 observations on the following 33 variables:

id

Subject identifier (numeric); leading digit indicates center. Range 1001–4003.

site

Study site (factor, 4 levels): 1_UM = University of Michigan, 2_IU = Indiana University, 3_UK = University of Kentucky, 4_Case = Case Western Reserve University.

age

Age in years (numeric), range 19–90.

risk

Risk score for post-ERCP pancreatitis (numeric), range 1–5.5.

gender

Sex (factor): 1_female, 2_male.

outcome

Primary outcome: post-ERCP pancreatitis (numeric, 1 = yes, 0 = no).

sod

Sphincter of Oddi dysfunction present (factor): 0_no, 1_yes.

pep

History of prior post-ERCP pancreatitis (factor): 0_no, 1_yes.

recpanc

History of recurrent pancreatitis (factor): 0_no, 1_yes.

psphinc

Pancreatic sphincterotomy performed (factor): 0_no, 1_yes.

precut

Sphincter pre-cut needed to enter papilla (factor): 0_no, 1_yes.

difcan

Cannulation of papilla was difficult (factor): 0_no, 1_yes.

pneudil

Pneumatic dilation of papilla performed (factor): 0_no, 1_yes.

amp

Ampullectomy performed (factor): 0_no, 1_yes.

paninj

Contrast injected into pancreas (factor): 0_no, 1_yes.

acinar

Pancreas appeared to have acinarization on imaging (factor): 0_no, 1_yes.

brush

Brushings taken from pancreatic duct (factor): 0_no, 1_yes.

asa81

Aspirin used at 81 mg per day (factor with 3 levels): 0_no, 1_yes, and a third level retained from the source coding.

asa325

Aspirin used at 325 mg per day (factor with 3 levels): 0_no, 1_yes, and a third level retained from the source coding.

asa

Aspirin used at any dose (factor with 3 levels): 0_no, 1_yes, and a third level retained from the source coding.

prophystent

Pancreatic duct stent placed per endoscopist judgment (factor): 0_no, 1_yes.

therastent

Pancreatic duct stent placed to treat narrowing (factor): 0_no, 1_yes.

pdstent

Pancreatic duct stent placed for any reason (factor): 0_no, 1_yes.

sodsom

Sphincter of Oddi manometry performed (factor): 0_no, 1_yes.

bsphinc

Biliary sphincterotomy performed (factor): 0_no, 1_yes.

bstent

Biliary stent placed to relieve obstruction (factor): 0_no, 1_yes.

chole

Choledocholithiasis present (factor): 0_no, 1_yes.

pbmal

Biliary duct or pancreatic malignancy found (factor): 0_no, 1_yes.

train

Trainee participated in ERCP (factor): 0_no, 1_yes.

status

Patient status (factor): 0_inpatient, 1_outpatient.

type

Sphincter of Oddi dysfunction type (factor): 0_no SOD, 1_type 1, 2_type 2, 3_type 3.

rx

Treatment assignment (numeric, 1 = indomethacin, 0 = placebo).

bleed

Reportable gastrointestinal bleeding (numeric, coded 1 = no, 2 = yes; NA when not assessed).

Source

Higgins, P. D. R. medicaldata: Data Package for Medical Datasets. R package, dataset indo_rct. https://CRAN.R-project.org/package=medicaldata

References

Elmunzer BJ, Higgins PDR, Saini SD, et al. A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. New England Journal of Medicine 2012; 366(15):1414–1422. doi:10.1056/NEJMoa1111103

Examples

data(indo)