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Abstracts of the 22
nd
National Congress of Digestive Diseases / Digestive and Liver Disease 48S2 (2016) e67–e231
e93
our health system, considering the subsequent diagnostic delay and
the number of unnecessary medical indemnities for CD prescribed.
OC.06.6
EFFECTS OF MODIFIED WHEAT GLUTEN ADMINISTRATION IN
PATIENTS WITH CELIAC DISEASE: RESULTS OF A DOUBLE-BLIND,
GLUTEN-CONTROLLED CLINICAL TRIAL
Marino M.
1
, Casale R.
1
, Di Nardi S.
1
, Gerratana G.
6
, Santulli M.
7
,
Angeloni A.
2
, Borghini R.
1
, Donato G.
3
, Porowska B.
4
, Tiberti A.
1
,
Rossi M.
5
, Di Tola M.
1
, Picarelli A.*
1
1
Department of Internal Medicine and Medical Specialties, Sapienza
University, Roma, Italy,
2
Department of Molecular Medicine, Sapienza
University, Roma, Italy,
3
Department of Clinical Medicine, Sapienza
University, Roma, Italy,
4
Department of General and Special Surgery
“Paride Stefanini”, Sapienza University, Roma, Italy,
5
Institute of
Food Sciences, National Research Council, Avellino, Italy,
6
UOC
DLC07 Laboratory Analysis DEA, Polyclinic Umberto I, Roma, Italy,
7
Department of Experimental Medicine, Sapienza University, Roma,
Italy
Background and aim:
The treatment of celiac disease (CD) is based
on a lifelong gluten-free diet (GFD). Recent studies showed that
biochemical modifications of gluten peptides, induced by microbial
transglutaminase (mTG) on wheat flour in the presence of lysine
ethyl ester (K-C2-H5), inhibit in vitro their ability to induce the CD-
specific immune response. Our aim was to perform a double-blind,
gluten-controlled clinical trial to evaluate the safety of a protracted
ingestion of mTG-modified wheat flour in CD patients.
Material and methods:
Twenty-two but 1 CD patients in remission
were randomized to receive, in double blind, rusks made with either
mTG-modified (Code A, n = 11) or unmodified (Code B, n = 10) wheat
flour. Every month for a total of 3 months, patients were asked to
complete an anamnestic card to monitor symptoms using a 100-
mm visual analogue scale (VAS), with 0 representing the absence
of symptoms. Serum anti-tissue transglutaminase (anti-tTG) and
endomysium antibodies (EMA), as well as creatinine concentration
were also monitored. At the end of the study, patients underwent
upper endoscopy with biopsy for duodenal histology and organ
culture system.
Results:
Five out of 11 patients who received rusks of Code A and 6
out of 10 patients who received rusks of Code B completed the study.
At baseline, all patients who completed the study showed serum
anti-tTG and EMA negative results. At the end of the study, one out
of 5 (20%) patients ingesting rusks of Code A and 4 out of 6 (66.7%)
patients taking rusks of Code B presented serum anti-tTG and EMA
positive results. In patients who received rusks of Code B, anti-tTG
serum levels determined after treatment were significantly higher
(p=0.0313) than those measured at baseline. No significant change
was found in the creatinine serum levels after treatment of all
patients who completed the study. At the end of the study, one out
of 5 (20%) patients ingesting rusks of Code A and 4 out of 6 (66.7%)
patients taking rusks of Code B presented intestinal villous atrophy.
Consistently, anti-tTG duodenal levels determined in patients who
received rusks of Code B tended to be higher than those measured
in patients who ate rusks of Code A. Swelling, meteorism and nausea
tended to be more severe in patients ingesting rusks of Code B than
those taking rusks of Code A.
Conclusions:
If data are confirmed, the enzymatic treatment of
wheat flour induced by mTG in the presence of K-C2-H5 could
become one of the most promising strategies for CD treatment
alternative to the GFD.
OC.06.7
RISK OF MISDIAGNOSIS AND OVERTREATMENT IN PATIENTS
WITH MAIN PANCREATIC DUCT DILATATION AND SUSPECTED
COMBINED/MAIN-DUCT IPMNS
Belfiori G.*
1
, Crippa S.
2
, Pergolini I.
1
, Rubini C.
3
, Castelli P.
3
,
Partelli S.
2
, Zardini C.
4
, Marchesini G.
5
, Zamboni G.
6
, Falconi M.
2
1
Department of Surgery, Università Politecnica delle Marche, Ospedali
Riuniti, Ancona, Italy,
2
Division of Pancreatic Surgery, Vita e Salute
University, San Raffaele Hospital, Milan, Italy,
3
Division of Pathology,
Università Politecnica delle Marche, Ancona, Italy,
4
General Surgery,
Sacro Cuore-Don Calabria Hospital, Negrar, Italy,
5
Biomedical Sciences
and Public Health Università Politecnica delle Marche, Ancona, Italy,
6
Pathology Sacro Cuore-Don Calabria Hospital, Negrar, Italy
Background and aim:
Segmental/diffuse dilatation of main
pancreatic duct (MPD) is the typical feature of combined/main-
duct intraductal papillary mucinous neoplasms (CMD-IPMNs). MPD
dilation in IPMNs may be also expression of mucus hypersecretion/
obstructive chronic pancreatitis (OCP). The aim of this study is to
evaluate the presence and extension of MPD involvement by tumor/
OCP and assess the risk of overtreatment.
Material and methods:
Retrospective analysis of suspected
CMD-IPMNs resected between January 2009 and October 2014.
Preoperative work-up included CT, MRI/MRCP and eventually EUS
with FNA. Pathological correlation among MPD dilatation, IPMN and
OCP was searched.
Results:
93 patients (60 males, 33 females; median age 67 years,
range 31-80) were resected for suspected CMD-IPMNs. All patients
underwent cross-sectional high-resolution imaging. MRI/MRCP
was performed in 89 patients (96%) and MDCT in 45 (48%) and 20
patients (22%) had an EUS-FNA. At pathology CMD-IPMNs were
found in 69 patients (74%). Branch-duct IPMNs (BD-IPMNs) were
found in 8 cases (9%), pancreatic ductal adenocarcinoma (PDAC) in
absence of IPMN in 9 (10%), cystic neuroendocrine tumor (NET G2) in
1 (1%), serous cystadenoma (SCA) in 2 (2%), and OCP alone/mucinous
metaplasia in 4 patients (4%). Overall, 18 patients (19%) underwent
an overtreatment because unnecessary (two BD-IPMNs, 2 serous
cystadenomas and 4 OCPs only) or too extensive resections (9 CMD-
IPMNs and one PDAC with associated OCP). Total pancreatectomy
was the most common procedure (67%) performed in these 18
patients. Preoperative work-up did not significantly differ between
patients who underwent overtreatment and the remaining ones,
although only 2/18 patients (11%) underwent EUS compared with
18/75 (24%) (P=0.194). Median size of MPD in IPMN-involved area
was 12 mm compared with 7 mm when only OCP was found (p <
0.05).
Conclusions:
There is a considerable risk of overtreatment in
patients with preoperative morphological diagnosis of CMD-
IPMNs. In order to improve their diagnostic accuracy, advanced
endoscopic techniques including EUS with FNA and pancreatoscopy
should be used more frequently. Partial pancreatectomy with
margin examination should be performed instead of upfront total
pancreatectomy. Radiological observation can be considered in
asymptomatic patients with “worrisome” MPD dilatation (5-9 mm)
and lacking other high-risk stigmata.
OC.06.8
INTEGRATED ANALYSIS OF EFFICACY OF PHASE II AND III DATA
OF OBETICHOLIC ACID IN PBC SUBPOPULATIONS BASED ON AGE
AND SEX
Pencek R.
1
, Lutz K.
1
, Marmon T.
1
, Macconell L.
1
, Picaro L.A.*
2
,
Adorini L.
1
, Shapiro D.
1
1
Intercept Pharmaceuticals, Inc, San Diego, California, United States,
2
Intercept Pharmaceuticals LTD Europe, London, United Kingdom