Prospective assessment of dynamic CT and MR cholangiography in functional biliary pain.

OBJECTIVE: The objectives of our study were to assess the feasibility of dynamic CT and MR cholangiography during gallbladder stimulation, to compare CT and MR cholangiography with biliary scintigraphy, and to identify morphologic differences between patients with functional biliary pain and healthy control subjects. SUBJECTS AND METHODS: In this prospective study, 30 patients with functional biliary pain underwent biliary scintigraphy, CT cholangiography, and MR cholangiography before and during 45-minute sincalide infusions. Thirty healthy control subjects also underwent MR cholangiography with sincalide infusion. IV contrast agents (iodipamide meglumine or gadobenate dimeglumine) were administered before scanning. CT and MR images were qualitatively and quantitatively analyzed. RESULTS: Diagnostic images were obtained of all participants. There was good agreement for gallbladder ejection fraction (EF) at 40 minutes by all three methods (Lin's concordance correlation coefficient ≥ 0.6). Gallbladder contraction and refilling occurred more promptly by CT and MR cholangiography than scintigraphy. CT and MR cholangiography showed previously undiagnosed gallstones in two patients (7%). Gallbladder shape was categorized as straight, curved, or folded; a folded gallbladder was present in 37% and 23% of patients at baseline and 40 minutes, respectively, versus in 3% of control subjects at both times (p ≤ 0.004). Asymmetric patterns of gallbladder contraction occurred in 10 patients (33%) and four control subjects (13%) (p = 0.13). CONCLUSION: Dynamic CT cholangiography and MR cholangiography performed during pharmacologic stimulation accurately measure gallbladder EFs and detect missed gallstones. Gallbladder shape before and during contraction differs between patients with functional biliary pain and healthy control subjects. Dynamic CT cholangiography and MR cholangiography are promising techniques that might improve selection of patients to undergo cholecystectomy for functional biliary pain.

Factors that predict relief from upper abdominal pain after cholecystectomy.

BACKGROUND & AIMS: Upper abdominal pain (UAP) in patients with gallstones is often treated by cholecystectomy but it frequently persists. We aimed to identify symptoms associated with relief. METHODS: We followed 1008 patients who received cholecystectomy for gallstones and UAP at the Mayo Clinic (Rochester, Minnesota) or Kaiser Permanente (San Diego, California) for 12 months. A validated, self-completed biliary symptoms questionnaire identified features of UAP, gastroesophageal reflux disease (GERD), and irritable bowel syndrome (IBS); the questionnaire was given initially and 3 and 12 months after cholecystectomy, to identify features that predicted sustained relief of UAP. RESULTS: Five hundred ninety-four patients (59%) reported relief from UAP. Factors associated univariately (P < .05) with relief included frequency of UAP ≤1 per month, onset ≤1 year preoperatively, usual duration (30 minutes to 24 hours, most often in the evening or night), and severity >5/10. Compared to no features, multiple predictive features of UAP (frequency, onset, duration, or timing) were associated with increasing odds ratios (95% confidence interval) for relief: 1, 2, or 3 features (4.2 [1.1-16]; P = .03) and 4 features (6.3 [1.6-25]; P = .008). Negative univariate associations included lower abdominal pain (LAP), usual bowel pattern, nausea ≥1 per week, often feeling bloated or burpy, GERD, and/or IBS. There was an inverse association between relief and somatization; relief was not associated with postprandial UAP. Multivariable logistic regression analysis revealed independent associations (P < .05) with UAP frequency, onset, and nocturnal awakening, but inverse associations with lower abdominal pain, abnormal bowel pattern, and frequent bloated or burpy feelings. CONCLUSIONS: UAP features and concomitant GERD, IBS, and somatization determine the odds for relief from UAP after cholecystectomy.

Tegaserod does not alter fasting or meal-induced biliary tract motility.

OBJECTIVE: Tegaserod is a 5-HT(4) receptor partial agonist that increases peristaltic activity of the intestinal tract. It is approved for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). IBS is a chronic gastrointestinal disorder of function that is reported to be associated with an increased incidence of abdominal surgery including cholecystectomy. The effect of tegaserod on nongut digestive organs, such as the gallbladder and biliary tract, has not been previously investigated. Therefore, this study aimed to evaluate the effects of tegaserod on gallbladder contractility and on functional status of the sphincter of Oddi during both the interdigestive and the digestive periods in healthy female subjects and in female patients with IBS-C. METHODS: During a 6-wk, double-blind, placebo-controlled crossover study, gallbladder contractility and concomitant change in luminal diameter of the common hepatic duct (CHD) and the common bile duct (CBD, both proximal and distal) in response to a standard liquid meal were quantified using real-time ultrasonography. Changes in luminal diameter of the CHD and the CBD were used as a surrogate marker for sphincter of Oddi function. Ultrasound measurements were conducted every 15 min from 45 min before, to 60 min after the test meal to observe the impact of tegaserod on gallbladder volume and any concomitant change in the diameters of the CHD and the CBD that developed in response to gallbladder contraction. The ultrasound measurements of gallbladder contractility, along with the CHD and the CBD diameters, were repeated after each of the two 2-wk periods of treatment with tegaserod or placebo. The recommended dose of tegaserod (6 mg b.i.d.) for IBS-C patients was used in healthy female subjects (n = 13) and female patients with IBS-C (n = 20). Twice this dose (12 mg b.i.d.) was also evaluated in an additional 20 female patients with IBS-C. Statistical evaluations were conducted using a two-sided analysis of variance (ANOVA). RESULTS: Gallbladder contractility variables including ejection fraction, ejection rate and ejection period, fasting and residual volume, and maximal emptying, were similar after 2 wk of treatment with tegaserod 6 mg b.i.d. and placebo in healthy female subjects and female patients with IBS-C. There were no significant changes in the luminal diameters of the CHD or the CBD after tegaserod compared to placebo in any cohort. Additionally, no significant dilation (> or =7 mm in diameter) of the CHD or CBD was observed during maximal gallbladder emptying. Similar results were also observed when tegaserod was given at 12 mg b.i.d. in patients with IBS-C. Tegaserod treatment had no significant effect on plasma CCK concentration in response to the test meal. No significant abdominal pain or unexpected adverse events were reported during the study. CONCLUSIONS: This study showed no significant pharmacodynamic effect of tegaserod on gallbladder contractility or on CBD and CHD diameters as a surrogate marker of sphincter of Oddi function during both the interdigestive (fasting) and the digestive (postprandial) periods in healthy female subjects and female patients with IBS-C.

A questionnaire for the assessment of biliary symptoms.

OBJECTIVES: Gallstone disease is common and causes high health care costs, but a measure of symptomatic biliary disease for outcome studies is lacking. We aimed to develop a reproducible, valid, discriminative, disease-specific measure of biliary symptoms. METHODS: We created the self-report Biliary Symptoms Questionnaire (BSQ) by combining possible biliary symptoms with validated items for gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), and other disorders. We developed the final version through an iterative process and assessed reproducibility by the test-retest method, concurrent validity by comparing BSQ responses with symptoms obtained by structured interview, and discriminative validity by comparing BSQ-based diagnoses of biliary symptoms, GERD, and IBS with patients' final diagnoses. A shortened version (sBSQ) also underwent reproducibility testing. RESULTS: A total of 245 outpatients (mean age, 55.2 yr; 61% female) participated. Median completion times for the BSQ and sBSQ were 36 and 10 min, respectively. For the BSQ, median kappa values were 0.65 (range -0.03 to 0.95) for reproducibility and 0.61 (range 0.15-0.95) for concurrent validity. Using BSQ responses, investigators distinguished IBS and GERD 79-90% of the time. For the sBSQ, the median kappa value for reproducibility was 0.72 (range 0.32-0.86). CONCLUSIONS: The BSQ is reproducible and has good concurrent and discriminative validity for biliary symptoms. The abridged sBSQ has good reproducibility. These instruments may be useful in future outcome studies.