Br. J. Surg. 1992, Vol. 79, December, 1342-1 345

G. L. Carlson, M. Rhodes, S. Stock, R . Lendrum*, M. I. Lavelle'f and C. W. Venables Departments of Surgery, *Medicine and ?Radiology, University of Newcastle upon Tyne. UK Correspondence to: Mr G . L. Carlson, Department of Surgery and North-western Injury Research Centre, Hope Hospital, Eccles Old Road, Salford M6 8HD, UK

Role of endoscopic retrograde cholangiopancreatography in the investigation of pain after c holecystectomy Patients who continue to have or who develop abdominal pain after apparently successful cholecystectomy pose diagnostic dificulties. This study reports 384 such patients, investigated by endoscopic retrograde cholangiopancreatography ( E R C P ) . There were 146 patients with abdominal pain alone with no previous history ~fcommon bile duct ( C B D ) exploration, of whom only I7 ( I 1.6 per cent) had CBD stones on ERCP. Bile duct calculi were present in 76 of 140 patients (54.3 per cent) with abnormal biochemical Jindings (raised alkaline phosphatase andlor amylase level) and in 34 of 57 (60 per cent) with an abnormality detected on ultrasonography or intravenous cholangiography. A combination o j biochemical and radiological abnormalities was present in 37 patients and was associated with CBD stones in 28 ( 76per cent ). Patients who had undergone C B D exploration represented a special group, of whom the majority ( 7 5 per cent) had common duct stones at E R C P even in the absence of biochemical and radiologicul abnormalities. E R C P is a useful investigation in patients with persistent postcholecystectomy symptoms. Other features in addition to pain or a history of CBD exploration may be relevant to the decision to perform E R C P in the investigation of' these patients.

Despite careful selection and attention to operative detail, some patients continue to complain of abdominal pain following cholecystectomy. In addition, patients may present later with abdominal pain after an initially successful operation. While there are a number of possible reasons for this pain, a major cause is that of common bile duct ( C B D ) stones either missed at the original operation or recurring subsequent to Until the advent of endoscopic retrograde cholangiopancreatography ( E R C P ) the diagnosis of such stones was difficult and their management problematic. ERCP has provided an accurate and satisfactory method for diagnosing CBD calculi and, with the development of endoscopic sphincterotomy (ES ), offers the possibility of treatment during the same ERCP is, however, an invasive procedure and is associated with a small but significant risk of complications, particularly if ES is performed. Under these circumstances major complication rates of 8-10 per cent and mortality rates of 1-2 per cent have been reported3-". It is therefore desirable to restrict its use to those patients in whom there is a reasonable probability that CBD stones are present. ERCP may be valuable in patients with abdominal pain after c h o l e c y s t e c t ~ r n ybut ~ ~it~ has ~ ~ to date proven difficult to define those in whom the procedure is most likely to be of benefit. This retrospective study aimed to define the factors that would predict the presence of CBD stones in patients referred for ERCP for persistent pain after cholecystectomy.

Patients and methods The records were reviewed of all ERCP examinations performed within the Newcastle Health Authority region between 1 January I976 and 31 December 1989. During this period over 5000 ERCP investigations were carried out. These included 466 consecutive patients investigated for abdominal pain after a previous cholecystectomy ( Table I ). All ERCP investigations were performed by, or in the presence of, an experienced endoscopist (M.I.L., R.L. or C.W.V.) using an Olympus (JFB2, JFBIT; Olympus, Lake Success, New York, USA) or Fujinon

1342

( X L ; Pyser, Kent, U K ) duodenoscope. An attempt was made to visualize the pancreatic and biliary systems in every case and incomplete visualization of either duct was regarded as failed examination of that system. Fiwiurc~.scvumined The medical records for all of these patients were examined and the age, sex and time interval after cholecystectomy recorded. It was noted whether or not the bile duct had been explored at the original operation. The clinical history was reviewed and results were recorded of serum alkaline phosphatase and amylase levels, and of the assessment of the CBD by ultrasonography and intravenous cholangiography. Ultrasonography was available only after 1978 and was performed on 368 patients. Intravenous cholangiography was carried out on 107. Abdominal pain was considered to be an indication for ERCP if it was epigastric or right hypochondrial, suggesting biliary or pancreatic pathology.

Mean age (years)

Mean interval since cholecystectomy (months)

140

24 126 49.91

544 63 1

78.4 768

51

14:43

54.4

91.0

37

8:29

61.6

87.6

Sex ratio (M F)

Clinical status

No.

Pain only Pain and clinical or biochemical abnormality Pain and imaging abnormality Pain and both clinical or biochemical and imaging abnormalities Failed investigation

1 50

82

30:52

58.2

82.5

Total

466

125:341

54.4

83.3

~

-

ERCP in pain after cholecystectomy: G. L. Carlson et al.

A raised serum amylase concentration was defined as that >90 units I - ' (normal range 20-90 units I - ' ) at the time of admission with abdominal pain. Amylase assays were performed on a Cobas Mira instrument (Roche, Welwyn Garden City, U K ) at 37°C using a blocked-substrate procedure consisting of p-nitrophenylmaltoheptaoside in the presence of glucose. Amylase activity was measured kinetically at 405 nm. A raised level of serum alkaline phosphatase was defined as one >115 units I - ' (normal range 25-115 units I - ' ) measured either during an admission with abdominal pain or at the time of admission for ERCP. Alkaline phosphatase assays were performed on an Olympus AU5000 analyser at 37°C using sodium p-nitrophenylphosphate in 2-amino-2-methyl-1-propanolbuffer at pH 10.5. Imaging abnormalities were also sought. Biliary dilatation was defined as a CBD diameter > 7 mm on ultrasonography using either an Acuson 128 (Acuson, Mountain View, California, USA) or Hewlett Packard 77020A (Hewlett Packard, Andover, Massachusetts, USA ) or > 11 mm on intravenous cholangiography. Biliary dilatation or the demonstration of a calculus by imaging was defined as an abnormal investigation. All intravenous cholangiograms were reviewed by one of the authors (M.I.L.); ultrasonography was performed by one of seven radiologists. Reported imaging investigations commented on the presence or absence of calculi or duct dilatation as defined above. It was not attempted to record CBD diameter in every case. Analysis of patient groups The patients studied were divided into four groups on the basis of their history and results of investigations. These were: (1) presentation with abdominal pain without history of jaundice or pancreatitis and with normal investigation findings; ( 2 ) pain and an additional history of jaundice or pancreatitis, and/or recorded high alkaline phosphatase or amylase levels but no imaging abnormality; ( 3 ) pain and an imaging abnormality alone; and ( 4 ) pain and abnormalities in the history and biochemical and imaging investigations. Statistical analysis Abnormality or a history of CBD exploration was assessed to predict the presence of any abnormality at ERCP, particularly the finding of common duct stones. This was performed by a comparison of proportions using the ,y2 test. The mean ages and intervals after cholecystectomy in patients with normal and abnormal ERCP results were compared using Student's t test and the Mann-Whitney 11 test respectively.

Results Successful cannulation of both biliary and pancreatic duct systems was achieved at ERCP in 384 patients (82.4 per cent), whereas cannulation of the pancreatic duct alone occurred in

25 (5.4 per cent) and that of the CBD alone in 20 (4.3 per cent). Neither duct was cannulated in 37 patients (7.9 per cent). Only those in whom both duct systems were cannulated were included in the analysis, to avoid the possibility that an alternative cause for the pain might be attributable to the duct system that was not cannulated. Table 2 shows the relationship between the clinical, laboratory and imaging findings and the presence of an abnormality on ERCP. The distribution of CBD stones was significantly different in the four patient groups ( x 2 = 39.62, 3 d.f., P < 0.001). The chance of finding stones at ERCP was significantly increased if there were any clinical, biochemical or imaging abnormalities present in addition to a history of abdominal pain ( x 2 = 54.30 and 45.30 respectively, 1 d.f., P < 0,001). There was no significant increase ( x2 = 0.40, 1 d.f., P > 0.05) in the predictive value for duct stones whether the abnormalities before ERCP were clinical, biochemical or imaging in nature. The presence of both a clinical or biochemical and an imaging abnormality added significantly to the chance of finding CBD stones at ERCP compared with a clinical or biochemical abnormality alone (1' = 5.07, 1 d.f., P < 0.003) but not when compared with an imaging abnormality alone ( x 2 = 2.43, 1 d.f., P > 0.1). Abnormalities other than stones found at ERCP are shown in Table 2 . Both clinical or biochemical ( x 2 = 51.99, 1 d.f., P < 0.001) and imaging (x' = 61.99, 1 d.f., P < 0,001) abnormalities significantly increased the diagnostic yield of ERCP. Patients with abnormal findings on ERCP were significantly older (mean(s.d.) age 55.8( 14.8) uersus 61.5(4.6) years; t = 5.17, 382 d.f., P < 0-001). There was, however, no difference in the

Table 3 Incidence of common bile duct stones found on endoscopic retrograde cholangiopancreatography in relation to clinical features and history of previous bile duct exploration Common bile duct exploration Clinical status

Performed

Not performed

Pain only ( n = 150) Pain and any abnormality* ( n = 234)

3 o f 4 (75) 28 of48 (58)

17 of 146 (11.6) 110 of 186 (59.1)

Values in parentheses are percentages. *Clinical or biochemical and/or imaging abnormality

Table 2 Abnormalities and common duct stones in 384 consecutive successful endoscopic retrograde cholangiopancreatography investigationsfor pain after cholecystectomy Clinical status

Abnormal ERCP

CBD stones

Other diagnoses

Pain only ( n = 150)

29 (19.3)

20 (13.3)

Stricture at cystic duct-CBD junction Chronic pancreatitis Ampullary stenosis

5 (3.3) 2 (1.3) 2 (1.3)

Pain and clinical or biochemical abnormality ( n = 140)

91 (65.0)

76 (54.3)

Ampullary stenosis Pancreas divisum Chronic pancreatitis Ampullary carcinoma Bilioenteric fistula Pancreatic carcinoma

5 (3.6) 4 (2.9

Pain and imaging abnormality ( n = 57)

42 (74)

34 (60)

Pancreatic carcinoma Leak from cystic duct stump Pseudocyst Ampullary stenosis Chronic pancreatitis

Pain and both clinical or biochemical and imaging abnormalities ( n = 37)

33 (89)

28 (76)

Chronic pancreatitis Cholangiocarcinoma Duodenal diverticulum compressing CBD

195 (50.8)

158 (41.1)

Total ( n = 384)

Values in parentheses are percentages. ERCP, endoscopic retrograde cholangiopancreatography; CBD, common bile duct

Br. J. Surg.. Vol. 79, No. 12, December 1992

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ERCP in pain after cholecystectomy: G.

L. Carlson et al.

median interval between cholecystectomy and presentation with abdominal pain when the groups with normal and abnormal ERCP were compared (median (range) 54.4 (3-408) uersus 48 ( 1 -432) months, P > 0-5). The relationship of bile duct stones to a history of previous exploration of the CBD is shown in Tuble3. When common duct stones were confirmed a successful ES with subsequent clearance of the duct (confirmed by repeat ERCP at 6 weeks) was performed in 98 patients (62.0 per cent). In a further 44 (27.8 per cent ), repeat endoscopic procedures were required before the duct was cleared and in 16 patients (10.1 per cent) surgical clearance of the duct was necessary.

Discussion Although the majority of patients with gallstone-related symptoms are cured8-’* by cholecystectomy, 5-40 per cent of patients continue to have pain or develop recurrent symptoms’. These patients generate difficulties in management and may undergo exhaustive investigation, often without a satisfactory conclusion. A specific ‘postcholecystectomy syndrome’ does not exist’, and many of these patients have other pathologies to explain their symptoms, such as peptic ulceration, gastro-oesophageal reflux or irritable bowel syndrome. The possibility of biliary or pancreatic pathology, however, is a natural source of concern to the clinician and requires investigation in many cases. The advent of ERCP has improved the assessment of such patients. This investigation also provides an opportunity for treatment at the same time if common duct stones are found. However, as the procedure carries a small but definite risk and is relatively expensive it is important to define any subgroups of patients in whom the diagnostic yield of ERCP is likely to be particularly high7. The diagnostic yield of ERCP in the postcholecystectomy patient with abdominal pain is higher in patients with jaundice and/or p a n c r e a t i t i ~ ’ ~In ~ ~ earlier ~. of patients without jaundice and/or pancreatitis, the incidence of normal ERCP findings was 33 and 38 per cent. In the present study, 80.7 per cent of patients without a biochemical or radiological abnormality had normal ERCP examinations. The discrepancy between these results and those of earlier studies may reflect the fact that the present patients without jaundice and/or pancreatitis had normal biochemical findings (in particular, a normal serum alkaline phosphatase level), suggesting that in the absence of overt jaundice or documented pancreatitis, a raised alkaline phosphatase concentration will predict an additional number of patients likely to benefit from early ERCP. Another factor that may

make comparison of separate studies difficult is selection bias in referral of patients for ERCP. This is difficult to rule out in any study but in the present case would have occurred before referral. All patients referred to this unit for management were investigated as described above. The present total diagnostic yield at ERCP of 50.8 per cent is significantly lower than that of 73 per cent reported earlier’. This discrepancy probably arises because the higher figure is based on a report in which patients known to have retained common duct stones and a T tube in situ were included, whereas the present study included only patients in whom the presence of pathology was unknown before ERCP, and those with a T tube were excluded. Another possible explanation for the relatively low diagnostic yield in the present series is the low incidence of dysfunction of the sphincter of Oddi. Although the incidence of CBD stones is similar (or even greater) than figures reported previously, the overall incidence of ampullary stenosis in the present study is only 2 per cent, compared with 9 per cent reported by Neoptolemos et a/.’ in a similar group of patients. This discrepancy may be due in part to patient selection, and failure in the present study to perform biliary manometry, which may be of value in predicting the response to ES in these patients. The presence of an imaging abnormality (usually biliary dilatation) was of predictive value for an abnormality at ERCP, although imaging alone was not a better predictor than the finding of a biochemical abnormality alone. The presence of both imaging and biochemical abnormalities was, however, of greater predictive value than biochemical abnormalities alone. The role of an isolated imaging abnormality must be considered in the light of the well recognized biliary dilatation that follows cholecystectomy, even in patients without biliary symptom^'^. Although this was taken into account by the radiologists reporting imaging investigations, the interpretation of such abnormalities has been q ~ e s t i o n e d ’ ~In. the present study, bile duct diameter was simply classified as ‘normal’ or ‘dilated’. A measurement of CBD diameter in relation to age might have allowed an assessment of whether a cut-off size would lead to refinements in the predictive value of imaging investigations. It is difficult to explain why a history of previous CBD exploration is such a good predictor of an abnormality at ERCP, and in particular, common duct stones. Although the numbers involved are small relative to the group as a whole, it is a cause for concern that the majority of patients who have undergone previous common duct exploration and continue to complain of pain have biliary pathology. This suggests that these patients should always be investigated by ERCP

Postcholecystectomy pain

.) P r e v i o u s CBD e x p l o r a t i o n ?

d

.)

Yes

No

Serum alkaline phosphatase

Abnormal Abnormal

I

1344

Normal

Normal

Oesophagogastroduodenoscopy B a r i u m enema

Normal

Abnormal

Br. J. Surg., Vol. 79, No. 12, December 1992

ERCP in pain after cholecystectomy: G. L. Carlson et al.

irrespective of the presence of another abnormality. The majority of these patients have CBD stones. Many of these calculi must have been left behind at the original exploration, although a proportion could have recurred within the duct system at a later time. There is increasing evidence, obtained from follow-up studies after clearance of the bile duct at operation and by ES, that bile duct calculi can re-form within the CBD, particularly when the duct is large in calibre''. This suggestion is supported by the long interval between a symptomatically successful operation and a new presentation with upper abdominal pain, leading to the diagnosis of stones in many of these patients. In summary, ERCP is a valuable method of assessing patients likely to have biliary or pancreatic pathology after cholecystectomy. The absence of biochemical and/or imaging abnormalities at assessment before ERCP may enable a more rational and cost-effective approach to this difficult group of patients by selecting for other investigations those who are likely to have a normal ERCP finding (Figure I ).

4.

5. 6. 7.

8. 9. 10.

11. 12. 13.

References I.

2. 3.

Blumgart LH, Sokhi GS, Duncan J G . Endoscopy and retrograde choledochopancreatogrdphy in the diagnosis of post-cholecystectomy symptoms. Bulletin dc lu Soci6ti; Intrrnutionulc~de Chirurgic 1975; 6 : 587-91. Sugawa C, Clift D, Walt AJ. Endoscopic retrograde cholangiopdncreatography after cholecystectomy. Surg Gynrc~olOhstrt 1983; 157: 247-51. Cotton PB, Chapman M, Whiteside CG, Le Quesne LP. Duodenoscopic papillotomy and gall-stone removal. Br J Surg 1976; 63: 709-14.

Br. J. Surg., Vol. 79, No. 12, December 1992

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Safrany L. Endoscopic treatment of biliary tract disease. An international study. Lancet 1978; ii: 983-5. Cotton PB, Vallon AG. British experience with duodenoscopic sphincterotomy for removal of bile duct stones. Br J Surg 1981: 68: 373-80. Ferguson DR, Sivak MV. Indications, contraindications and complications of ERCP. In: Sivak MV, ed. Gustroenterologic Endoscopy. Philadelphia: WB paunders, 1987: 581-99. Ruddell WSJ, Lintott DJ, Ashton MG, Axon ATR. Endoscopic retrograde cholangiography and pancreatography in the investigation of post-cholecystectomy patients. Lancet 1980; i: 44-7. Bodvall B. The post-cholecystectomy syndrome. Bui/lieres Clin Gastroenterol 1973; 2: 103-26. Schofield GE, Macleod RG. Sequelae of cholecystectomy. Br J Surg 1966; 53: 1042-6. Burnett W, Shields R. Symptoms after cholecystectomy. Lancet 1958; i : 923-5. Le Quesne LP, Whiteside TG, Hand B. The common bile duct after cholecystectomy. BMJ 1959; i : 329-32. Rhodes M, Lennard T. Cholecystectomy for gallstones. B M J 1989; 298: 526 (Letter). Neoptolemos JP, Bailey IS, Carr-Locke DL. Sphincter of Oddi dysfunction: results of treatment by endoscopic sphincterotomy. Br J Surg 1988; 75: 454-9. Chung SCS, Leung JWC, Li AKC. Bile duct size after cholecystectomy : an endoscopic retrograde cholangiopancreatographic study. Br J Sury 1990; 77: 534-5. Bar-Meir S, Halpern Z. The significance of the diameter of the common bile duct in cholecystectomized patients. A m J Gustroenterol 1984; 79: 59-60. Nagase M, Setoyama M, Hikosa Y. Recurrent common duct stones with special reference to primary common duct stones. Gastroenterol Jpn 1978; 13: 290-6.

Paper accepted 22 June 1992

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Role of endoscopic retrograde cholangiopancreatography in the investigation of pain after cholecystectomy.

Patients who continue to have or who develop abdominal pain after apparently successful cholecystectomy pose diagnostic difficulties. This study repor...
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