Multicenter approach to recurrent acute and chronic pancreatitis in the United States: the North American Pancreatitis Study 2 (NAPS2).
BACKGROUND
Recurrent acute pancreatitis (RAP) and chronic pancreatitis (CP) are complex syndromes associated with numerous etiologies, clinical variables and complications. We developed the North American Pancreatitis Study 2 (NAPS2) to be sufficiently powered to understand the complex environmental, metabolic and genetic mechanisms underlying RAP and CP.


METHODS
Between August 2000 and September 2006, a consortium of 20 expert academic and private sites prospectively ascertained 1,000 human subjects with RAP or CP, plus 695 controls (spouse, family, friend or unrelated). Standardized questionnaires were completed by both the physicians and study subjects and blood was drawn for genomic DNA and biomarker studies. All data were double-entered into a database and systematically reviewed to minimize errors and include missing data.


RESULTS
A total of 1,000 subjects (460 RAP, 540 CP) and 695 controls who completed consent forms and questionnaires and donated blood samples comprised the final dataset. Data were organized according to diagnosis, supporting documentation, etiological classification, clinical signs and symptoms (including pain patterns and duration, and quality of life), past medical history, family history, environmental exposures (including alcohol and tobacco use), medication use and therapeutic interventions. Upon achieving the target enrollment, data were organized and classified to facilitate future analysis. The approaches, rationale and datasets are described, along with final demographic results.


CONCLUSIONS
The NAPS2 consortium has successfully completed a prospective ascertainment of 1,000 subjects with RAP and CP from the USA. These data will be useful in elucidating the environmental, metabolic and genetic conditions, and to investigate the complex interactions that underlie RAP and CP.
Whitcomb
David C
DC
Department of Medicine, University of Pittsburgh, Pittsburgh, PA 15213, USA. whitcomb@pitt.edu
Yadav
Dhiraj
D
Adam
Slivka
S
Hawes
Robert H
RH
Brand
Randall E
RE
Anderson
Michelle A
MA
Money
Mary E
ME
Banks
Peter A
PA
Bishop
Michele D
MD
Baillie
John
J
Sherman
Stuart
S
DiSario
James
J
Burton
Frank R
FR
Gardner
Timothy B
TB
Amann
Stephen T
ST
Gelrud
Andres
A
Lo
Simon K
SK
DeMeo
Mark T
MT
Steinberg
William M
WM
Kochman
Michael L
ML
Etemad
Babak
B
Forsmark
Christopher E
CE
Elinoff
Beth
B
Greer
Julia B
JB
O'Connell
Michael
M
Lamb
Janette
J
Barmada
M Michael
MM