THE AMERICAN JOURNAL OF GASTROENTEROLOGY
1, 2000
© 2000 by Am. Coll. of Gastroenterology
Published by Elsevier Science Inc.
Ampullary Obstruction
Monitoring in Acute Gallstone
Pancreatitis: A Safe, Accurate, and Reliable
Method to Detect Pancreatic Ductal Obstruction
Juan M. Acosta, M.D., Gustavo D. Ronzano, M.D., and Carlos A. Pellegrini, M.D.
Departamento de Cirugı́a, Facultad de Ciencias Médicas, Universidad Nacional de Rosario, Rosario,
Argentina; and Department of Surgery, University of Washington, Seattle, Washington
OBJECTIVE: The aim of this study was to determine the value
of ordinary clinical and laboratory data, including the mon-
itoring of ampullary gallstone obstruction in the early
phases of the disease, in the diagnosis of acute gallstone
pancreatitis (AGP).
METHODS: One hundred and thirty-two patients were
studied. The inclusion criteria were admission within 48 h
from the onset of symptoms, clinical presentation com-
patible with AGP, bile-free gastric aspirate, elevation of
serum amylase and bilirubin, and ultrasonographic dem-
onstration of cholelithiasis. Monitoring of ampullary
obstruction included severity of pain, presence of bile in
the gastric aspirate, and serial serum bilirubin determi-
nations. The clinical diagnosis of AGP was confirmed or
excluded by surgical exploration, and that of ampullary
obstruction by intraoperative cholangiography (IOC)
or endoscopic retrograde cholangiopancreatography
(ERCP).
RESULTS: The overall accuracy of the diagnostic tests for
AGP was high: sensitivity, 0.94; specificity, 0.99; positive
predictive value, 0.95; and negative predictive value, 0.99.
Detection of spontaneous ampullary decompression was
correct in 100% of the patients, and that of ampullary
obstruction, in 61%. The accuracy of this test was sensitiv-
ity, 1.0; specificity, 0.92; positive predictive value, 0.61; and
negative predictive value, 1.0.
CONCLUSIONS: Clinical criteria and ordinary laboratory de-
terminations are sufficiently accurate to discriminate be-
tween patients with AGP and those with other acute
abdominal pathologies. Careful monitoring of patients’
pain, quality of nasogastric aspirate, and serum bilirubin
level can accurately identify the few cases with persistent
ampullary obstruction. Those patients can then be se-
lected for intervention to restore the ampullary patency
and prevent progression of acute pancreatitis. (Am J
Gastroenterol 2000;95:122–127. © 2000 by Am. Coll. of
Gastroenterology)
Vol. 95, No.
ISSN 0002-9270/00/$20.00
PII S0002-9270(99)00730-3
INTRODUCTION
There is substantial experimental (1, 2) and clinical (3– 6)
evidence that ampullary gallstone obstruction not only ini-
tiates but also maintains and aggravates biliary pancreatitis.
A previous study from our institution comprising 97 patients
with acute gallstone pancreatitis (AGP) secondary to gall-
stone impaction at the ampulla showed that the duration of
ampullary obstruction is a major factor determining the
severity of pancreatic injury. The incidence of severe pan-
creatic injury was 10.6% in patients when obstruction lasted
⬍48 h, and 84.6% in those whose obstruction persisted ⬎48
h (7).
During the last decade a number of authors have advo-
cated the diagnostic and therapeutic value of endoscopic
retrograde cholangiopancreatography (ERCP) in patients
with AGP (8 –12). At present, there is no doubt that patients
with severe or worsening pancreatitis associated with biliary
obstruction will benefit from this procedure. However, such
patients are a minority, as in most patients gallstones mi-
grate spontaneously within 48 h and the process resolves
rapidly and completely by itself.
A confounding factor is the impossibility of predicting
which patients will pass their stones spontaneously (and
promptly) and which will not. Performing emergency ERCP
(i.e., ⬍48 h) routinely subjects all patients to the morbidity
and mortality of this procedure (13, 14), although the ma-
jority would not be expected to benefit from it.
Several methods to detect gallstone impaction at the am-
pulla have been advocated. In 1981 Coppa et al. (15) re-
ported the results of percutaneous transhepatic cholangiog-
raphy (PTC). In 1983 Neoptolemos et al. (16) and in 1996
Bolognese et al. (17) studied radioisotopic imaging of the
biliary tree in patients with pancreatitis and suspected com-
mon bile duct stones. These methods are either cumbersome
or involve risk, the number of patients studied was small,
and the results were equivocal.
We conducted a prospective study that included 132
consecutive patients with acute pancreatitis and biliary ob-
struction who were seen within 48 h from the onset of
AJG – January, 2000
symptoms. This study was performed to assess the value of
ordinary clinical and laboratory data in establishing the
diagnosis of AGP, and to predict the course of gallstone
obstruction of the ampulla in the initial phases of the dis-
ease. We expected that if these methods established a con-
fident diagnosis of ampullary gallstone obstruction during
an attack of pancreatitis, they would provide the stimulus for
early intervention to remove the offending stone.
MATERIALS AND METHODS
Inclusion Criteria
Acute pancreatitis was assumed to have a biliary origin if
the patient presented with an appropriate clinical picture,
and cholelithiasis was seen on ultrasound scan at admission,
or there was a history of previous cholecystectomy for
cholelithiasis. In addition, patients had to meet the following
inclusion criteria: admission within 48 h after the onset of
symptoms, bile-free gastric aspirate, elevation of serum
amylase level at least two times the upper normal value
(120 ⫾ 2.5 U/dl, by the method of Smith and Roe [18]),
elevation of serum bilirubin level to at least 1.4 mg/dl
(normal value, 0.98 ⫾ 0.04 mg/dl, by the method of Malloy
and Evelyn [19]), and no history of alcohol abuse or other
known etiological factor for acute pancreatitis.
Clinical Material
Between January 1986 and December 1996, a total of 259
patients with the diagnosis of acute pancreatitis of any origin
were admitted at the Hospital Escuela Eva Perón, Granadero
Baigorria, Santa Fé, Argentina. One hundred and thirty-two
of these patients were assumed to have AGP, met all the
criteria for inclusion, and were enrolled. Patients’ age av-
eraged 41.3 (range, 16 – 85) yr; 103 were women, and 29
were men. Serum bilirubin level at admission averaged 4.2
(range, 1.4 –12.7) mg/dl, and serum amylase level was 1,312
(range, 256 –14,600) U/dl.
Ultrasound scanning within 24 h of admission revealed
gallbladder stones (n ⫽ 122) or muddy bile (n ⫽ 4) in 94%
(126/132) of the patients; no abnormalities were observed in
two patients, and the gallbladder was not visualized in the
remaining four patients, who had previously undergone
cholecystectomy. The pancreas showed changes consistent
with acute pancreatitis in 47% (62/132) of the cases; in the
remaining 53% (70/132), the pancreas showed either no
alteration or was not visualized.
The severity of acute pancreatitis was evaluated at ad-
mission and before treatment according to personal clinical-
biochemical criteria,1 and at 48 h from admission by the
criteria of Ranson et al. (20). By the first (personal) assess-
ment, pancreatitis was classified as mild in 66 patients,
moderate in 65 patients, and severe in one patient. Applying
1. Criteria of severity of acute pancreatitis (7): Mild, mild or moderate symptoms
(particularly pain) with minimal local manifestations; moderate, moderate or intense
symptoms (particularly pain) with obvious local manifestations; severe, intense symp-
toms (particularly pain) with both, local and systemic manifestations.
Ampullary Obstruction Monitoring in AGP 123
Ranson et al.’s criteria showed that 101 patients did not
have any of the risk factors, 29 patients presented one or two
risk factors, and the remaining two patients presented with
three.
Study Design
All patients in this series were considered eligible at admis-
sion for early ampullary stone disimpaction no later than
48 h from the onset of symptoms. That limit was chosen on
the basis that beyond it, the expected incidence of severe
pancreatic lesions increases significantly (7). To measure
duration of ampullary obstruction, the time of its onset
(assumed as the time of the onset of symptoms) was care-
fully and systematically investigated and recorded in every
patient.
Initial therapy consisted of analgesics (hyoscine butil-
bromuro, 20 mg i.v.), intravenous fluids, broad-spectrum
antibiotics (ampicillin, 1 g i.v. every 6 h, and gentamicin, 80
mg i.v. every 8 h) and nasogastric suction. Monitoring of
ampullary obstruction was done using three parameters:
severity of the disease, particularly intensity of abdominal
pain using a graded scale of 1– 42 checked at intervals of 4
to 6 h; presence of bile in the gastric aspirate, checked every
6 h; and serum bilirubin level determined at admission, and
every 6 h thereafter.
The management protocol was as follows. The patients
who showed signs of spontaneous ampullary decompres-
sion, such as rapid relief of pain, sudden appearance of
golden bile in the gastric aspirate, and a significant fall of
serum bilirubin within 48 h from the onset of symptoms,
were reconsidered for elective biliary surgery during the
same admission. The remaining patients, who did not show
signs of decompression, had intervention to remove the
offending stone within the previously identified period.
However, the exact timing of operation in these patients—
though within the preestablished 48-h period— depended
upon a number of variables besides duration of obstruction.
Severe unremitting, increasing, or recurrent pain, associated
with stable or increasing jaundice and bile-free gastric as-
pirate, as well as the appearance of tenderness, manifest
ileus, fever, or other systemic manifestations, was consid-
ered an indication for immediate decompression. The pres-
ence of associated conditions, such as morbid obesity, preg-
nancy, recent myocardial infarction or cerebrovascular
accident, was considered indication for delaying surgery as
long as permitted by the 48-h limit. To be able to perform
the operation within the preestablished time limit, surgical
ampullary decompression was anticipated by no later than
36 h from the onset of symptoms.
2. Abdominal Pain Scale of Severity: 1 ⫽ spontaneous pain, requiring analgesics
every 6 h; 2 ⫽ spontaneous pain and tenderness, requiring analgesics every 4 h; 3 ⫽
sharp pain, tenderness, and ileus, requiring analgesics every 3 h or more frequently;
4 ⫽ sharp and continuous pain, tenderness, and ileus, frequently accompanied by
systemic manifestations, requiring analgesics continuously.
124 Acosta et al. AJG – Vol. 95, No. 1, 2000

Statistical Analysis Table 1. Incidence of Common Duct Stones in 121 Patients

To calculate the accuracy of the methods employed to With Acute Gallstone Pancreatitis Receiving Intervention on
Elective (Group A) or Urgent (Group B) Basis
discriminate AGP from other disease processes and to detect
ampullary gallstone obstruction in such patients, the follow- Common Duct Group A Group B Total
ing standards were defined (21). We assumed the presence Stones (n ⫽ 98) (n ⫽ 23) (n ⫽ 121)
of AGP when cholelithiasis coexisted with macroscopic Impacted 0 (0%) 14 (61%) 14 (11.5%)
lesions of acute pancreatitis such as edema, fat necrosis, Not impacted 17 (17%) 3 (13%) 20 (16.5%)
Total 17 (17%) 17 (74%) 34 (28%)
hemorrhage, or parenchymal necrosis, during surgical ex-
ploration; gallstone obstruction of the ampulla was assumed
when contrast failed to reach the duodenum during intraop- Surgical and Endoscopic Findings
erative cholangiography (IOC) or when confirmed at sur- In Group A, gallbladder stones were found in 93 patients,
gery or by direct observation of the papilla (DPO) during and cholesterolosis in two. The remaining three patients had
ERCP. had prior cholecystectomy. A patent ampulla clinically sus-
To evaluate the accuracy of the diagnostic tests for AGP, pected was found in all 98 patients in this group, 95 by IOC,
we had to consider 4,209 patients in whom such diagnosis and three by ERCP. Common duct stones were detected in
had been excluded, but who were operated on during the 17 (17%) patients, but in none of them was a stone found
period of the study (1986 –1996, inclusive) and within a impacted at the ampulla (Table 1). Changes consistent with
comparable interval from the onset of symptoms, x ⫽ 4.6 resolving acute pancreatitis were seen in 92 patients, and no
(1–15) days, as seen in AGP patients. The clinical diagnoses abnormalities were detected in the remaining six (Table 2).
in this group were acute appendicitis (1,927 cases), acute In Group B, gallbladder stones were found in 21 patients,
cholecystitis (1,430), bowel obstruction (381), sigmoid di- and cholesterolosis in one. The remaining patient had pre-
verticulitis (177), obstructive jaundice and cholangitis viously undergone cholecystectomy. Common duct studies
(117), acute abdomen of unknown etiology (96), perforated by IOC in 17 patients or by DPO in six patients (ERCP, two
peptic ulcer (69), complicated aorta aneurysm (six), bowel cases, and exploratory duodenotomy, four cases) revealed
infarction (five), and acute nonbiliary pancreatitis (one). common duct stones in 17 (74%) patients, among whom 14
Statistical analyses were performed by means of Student’s t (61%) had a stone impacted at the ampulla (Table 1). The
tests (two-tailed) (22). remaining nine patients showed a patent ampulla at the time
of exploration. However, in six of these nine patients, phys-
ical evidence of recent transpapillary stone migration was
RESULTS observed: one or more gallstones free in the duodenal or
jejunal lumen seen through a transparent bowel wall (three
Clinical Course cases) and acute lesions, such as tears and ecchymosis, at the
After admission, the 132 patients studied demonstrated two papillary meatus (three cases). Typical lesions of acute
distinct patterns of evolution. The great majority, 83% (109/ pancreatitis were observed at surgery in 21 patients (Table
132), showed signs of ampullary decompression such as 2). The remaining two patients were subjected to ERCP plus
rapid relief of pain from grades 2–3 to grades 0 –1, sudden endoscopic sphincterotomy (ES) during the attack and, as
appearance of golden clear bile in the gastric aspirate, and a the pancreas was not adequately visualized at that time, the
significant fall of elevated serum bilirubin level (mean, cases were not considered for evaluation of the diagnosis of
37.5%) from 4.8 to 3 mg/dl (mean values) (p ⬍ 0.001) AGP.
within 48 (x ⫽ 26) h after the onset of symptoms (Group A).
The remaining 17% (23/132) showed typical signs of per- Operative Management
sistent ampullary gallstone obstruction, such as severe un- Free common duct stones were removed by chole-
remitting or increasing pain (grades 2–3) associated with dochotomy in the patients subjected to open surgery in
stable or increasing elevated serum bilirubin, mean peak
value ⫽ 6.8 mg/dl (2.5–11.0), and bile-free gastric aspirate, Table 2. Incidence of Lesions of Acute Pancreatitis in 119
as well as the appearance of epigastric tenderness, manifest Patients With Diagnosis of AGP Subjected to Open Surgery on
ileus, or fever (Group B). Eleven of the 109 patients in Elective (Group A) or Urgent (Group B) Basis
Group A were treated successfully during their attacks of Lesions of Acute Group A Group B Total
AGP by conservative measures only, and received no sub- Pancreatitis (n ⫽ 98) (n ⫽ 21) (n ⫽ 119)
sequent treatment in our service. They were excluded from Present 92 (94%) 21 (100%) 113 (95%)
this study. The remaining 98 patients of Group A received Edema 56 9 65
Fat necrosis 35 8 43
elective intervention for the associated cholelithiasis once Hemorrhage 1 3 4
the attack subsided, between 1 and 17 days (mean, 4.3 days) Necrosis 0 1 1
after the onset of symptoms. The 23 patients in Group B Absent 6 (6%) 0 (0%) 6 (5%)
were operated on urgently, between 18 and 48 h (mean, Total 98 (100%) 21 (100%) 119 (100%)
37 h) from the onset of symptoms. AGP ⫽ acute gallstone pancreatitis.
AJG – January, 2000
Table 3. Technical Procedures Performed in 121 Patients
Divided Into Two Groups, A and B
Group A Group B
Technical Procedures (n ⫽ 98) (n ⫽ 23)
Surgery 98 21
Cholecystectomy 67 4 71
CDE 31* 17†
Choledochotomy ⫹ T-tube 24 10
drain
Choledochoduodenostomy 3 1
Papillotomy 1 6
ERCP ⫹ ES 3 3
ERCP ⫹ ES 2 2
Total 98 23
* In 28 cases, in association with cholecystectomy, and in three previously cholecys-
tectomized patients, as a unique procedure.
† In 16 cases, in association with cholecystectomy, and in the remaining previ-
ously cholecystectomized patients, as a unique procedure.
CDE ⫽ common duct exploration; ES ⫽ endoscopic sphincterotomy; ERCP ⫽
endoscopic retrograde pancreatography.
either group, and by ES in three patients of Group A sub-
jected to ERCP as the initial procedure. In the 14 patients of
Group B in whom a stone was found impacted at the
ampulla, the stone was removed by papillotomy in eight
patients (transduodenal, six cases, and endoscopic, two cas-
es), and by maneuvers that avoided papillotomy (removal of
the stone through choledochotomy, three cases, and by
pushing the stone with a probe toward the duodenum, three
cases) in the remaining six patients, all of whom were
subjected to open surgery. The operative procedures per-
formed in both groups are listed in Table 3. In the five
patients primarily subjected to ERCP plus ES (Group A,
three cases, and Group B, two cases) standard or laparo-
scopic cholecystectomy was carried out electively within 17
days after the onset of symptoms.
Postoperative Course
All the patients in Group B showed signs of ampullary
decompression such as rapid relief of pain (grades 2–3 to
0 –1), sudden appearance of bile in the gastric aspirate, and
a significant fall (averaging 45%) in serum bilirubin level,
from 6.2 to 3.4 mg/dl within 6 h after endoscopic or surgical
decompression. Eleven (9%) of the 121 patients operated on
in this series had immediate postoperative complications.
None of them required reoperation, and all recovered un-
eventfully. There were no deaths. Eighty-six (71%) patients
were monitored during a follow-up period of between 2 and
12 yr (mean, 6.5 yr). Only one patient in Group A developed
an episode of AGP with cholangitis, 8 yr after hospital
discharge. The attack subsided 30 h after the onset of
symptoms, and on the 12th day of admission ERCP plus
ES was performed. Muddy bile and small calculi were
removed from the common duct. The patient’s recovery
was uneventful.
Accuracy of the Diagnostic Methods
Open surgical exploration was carried out in 119 patients
(Group A, 98 and Group B, 21) in whom a clinical and
Ampullary Obstruction Monitoring in AGP 125
Table 4. Accuracy of Ordinary Clinical and Laboratory Data in
the Diagnosis of Biliary Pancreatitis, and in Monitoring
Ampullary Gallstone Obstruction
Total
(n ⫽ 121) Biliary Ampullary Gallstone
119 Pancreatitis Obstruction
Accuracy Factor (n ⫽ 119)* (n ⫽ 121)†
48 Sensitivity 0.94 1.0
34 Specificity 0.99 0.92
Positive predictive value 0.95 0.61
4 Negative predictive value 0.99 1.0
7 * Total number of patients who were subjected to open surgical exploration to confirm
or exclude the diagnosis of AGP.
† Total number of patients who were subjected to IOC and/or to DPO (ERCP or
121 exploratory duodenotomy) to confirm or exclude the diagnosis of ampullary gallstone
obstruction.
AGP ⫽ acute gallstone pancreatitis; IOC ⫽ intraoperative cholangiography; DPO
⫽ direct papilla observation; ERCP ⫽ endoscopic retrograde pancreatography.
laboratory diagnosis of AGP had been made. It revealed that
113 had cholelithiasis associated with lesions typical of
acute pancreatitis (true-positive cases). The remaining six
patients showed cholelithiasis but no lesions suggestive of
pancreatitis (false-positive cases). On the other hand, surgi-
cal exploration carried out in the 4209 control patients in
whom the diagnosis of AGP had been excluded showed that
the exclusion diagnosis was correct in 4202 patients (true-
negative cases) and incorrect in the remaining seven. The
lesions of acute pancreatitis found in this latter group were
edema (two cases), fat necrosis (two), and hemorrhage
(three). All these latter patients showed cholelithiasis also
(false-negative cases).
Exploration of common bile duct by IOC or DPO in 121
patients (Group A, 98; Group B, 23) revealed that monitor-
ing of ampullary obstruction was a highly efficient way to
recognize ampullary decompression; this diagnosis was cor-
rect in all the 98 patients (100%) in whom it was made
(true-negative cases). On the contrary, the diagnosis of
ampullary obstruction was wrong in 39% (9/23) of cases
(false-positive cases).
The accuracy of the methods used to discriminate the
patients with AGP from those with other acute abdominal
conditions, and to detect ampullary gallstone obstruction in
such patients in terms of sensitivity, specificity, and positive
and negative predictive values, is represented in Table 4.
DISCUSSION
The results of this study strongly suggest that our method—
based on simple, safe, and easily available tests—accurately
diagnoses AGP. Indeed, its accuracy was high; the sensi-
tivity was 94%, with a specificity of 99.8%. When the test
was positive for AGP and the patients were explored oper-
atively, 95% of them showed clear signs of the suspected
condition. Delay in surgery may explain the six false-posi-
tive cases, as the mean time to exploration was 6.4 days,
compared with 4.3 days for the true-positive cases. When
AGP was excluded by the method described, surgical ex-
ploration demonstrated that ⬍1% of such patients actually
had AGP.
126 Acosta et al.
The results obtained from the method used to monitor
ampullary obstruction indicate that this may be a very useful
way to manage biliary pancreatitis. It is important to con-
sider that in 88% (107/121) of our patients the gallstone
initiating the episode of pancreatitis migrated spontaneously
through the ampulla within 48 h from the onset of symp-
toms. Thus, neither emergency surgery nor ERCP with
papillotomy would have been beneficial or necessary in
these patients. To treat these patients correctly one needs to
know whether the causative stone remains blocking the
ampulla. Our study showed that when signs of ampullary
decompression were present, 100% of such patients had a
patent ampulla at the time of surgery because of migration
of the impacted stone. On the other hand, when signs of
ampullary obstruction persisted and the patients were oper-
ated on within 48 h of evolution, only 61% (14/23) of them
had an impacted stone at the ampulla, which was removed.
It is important to emphasize that six of the nine patients with
diagnosis of ampullary obstruction had a patent ampulla
with signs of recent stone migration at the time of surgical
exploration. Nevertheless, it remains uncertain whether or
not it would be beneficial for these patients to delay the
intervention for a few more hours in the expectation of
impending gallstone migration. If that did not occur within
the first 48 h, the risk of severe pancreatitis might be
significantly increased (7). In addition, such risk is more
than hypothetical as, according to our experience, ⬍l5% of
stone migrations occurred after 36 h of obstruction.
Using ultrasonography, we were able to detect gallblad-
der stones in 94% of patients. This observation differs from
other studies in which the procedure was hampered by
excessive gas in the bowel associated with the ileus of
severe acute pancreatitis (23–25). This finding is highly
consistent with the low incidence of severe pancreatitis in
our series (⬍1%) assessed by two different criteria. The fact
that 95% (113/119) of the patients explored at surgery
proved to have cholelithiasis and obvious lesions of acute
pancreatitis is a solid argument against the term “pseudo-
pancreatitis,” coined to describe the condition of patients
with hyperamylasemia and minimal clinical manifestations
(26). Such a term leads to confusion, because such patients
may indeed have genuine acute pancreatitis, albeit mild.
The overall percentage of successful diagnosis of the
presence and absence of ampullary obstruction in this series
was 93% (123/132). The high success rate observed in our
study might be due to the high accuracy of our method of
diagnosing ampullary decompression, which, in fact, is the
most important issue that needs to be determined for appro-
priate management. Indeed, correct and timely diagnosis of
a patent ampulla by this method prevented unnecessary
urgent intervention in 83% (109/132) of our patients, all of
whom recovered uneventfully from their attack. Thus, using
this method, only nine patients (7%) underwent urgent ex-
ploration of their ampulla (by ERCP or operation), which,
although unnecessary, did not seem to impact negatively on
their outcome.
AJG – Vol. 95, No. 1, 2000
In conclusion, we suggest that this study has two impor-
tant findings. An accurate diagnosis of AGP can be made
using basic clinical and easily obtained laboratory data.
Further, using our method it is possible to identify patients
with persisting obstruction of the ampulla requiring urgent
decompression, and to spare those who have already passed
their stones unnecessary procedures, such as ERCP and
exploratory surgery.
ACKNOWLEDMENTS
We are indebted to Dr. Frida Bergmann, and to Dr. Mónica
Liborio for their expert assistance in the statistical analyses,
and to Dr. Jean Mc Allister for her invaluable editorial
assistance.
Reprint requests and correspondence: Juan M. Acosta, M.D.,
Profesor Titular, Universidad Nacional de Rosario, Facultad de
Ciencias Médicas, Pte. Roca 786 Piso 1, 2000-Rosario, Argentina.
Received Sep. 10, 1998; accepted Sep. 24, 1999.
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