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Abstract Background The use of Lamivudine in chronic hepatitis B (CHB) is well known, however the reported rate of HBeAg sero-conversion and its durability post-treatment have varied considerably. We undertook the present study to study the effect of Lamivudine on HBeAg loss and seroconversion rates in Indian patients of CHB in relation to frequency, predictors and durability. Methods We treated 60 patients of e antigen positive CHB (with active viral replication and ongoing necro-inflammatory activity) with Lamivudine. They were followed up by monthly aminotransferases, and 3 monthly HBeAg and anti-HBe. Those who attained HBeAg sero-conversion were advised to discontinue Lamivudine after 6 months and followed up every 3 months thereafter, to see for relapse. Treatment was given for maximum of 3 years if not sero-converted. Results The annual incremental loss of HBeAg in patients receiving Lamivudine was 25 (41.6%) at end of 1st year, 33 (55%) at 2nd year and 35 (58.3%) at 3rd year. The corresponding rates for full sero-conversion were 17/60 (28.6%), 22/60 (36.6%) and 24/60 (40%) in the 3 years. HBeAg loss correlated with increased pre-therapy ALT levels (p = 0.002) and decreased pretreatment HBV-DNA levels (p = 0.004). The presence of cirrhosis had no influence on the rate of HBeAg loss. Relapse occurred in 35% (7/20) post-treatment at median time of 6 months. Conclusion Indian patients showed a higher rate of HBeAg sero-conversion in the first year of Lamivudine treatment. This correlated with baseline ALT and inversely with HBV-DNA levels. Relapse rate after treatment was high and occurred soon after stopping treatment.

Background: Liver stiffness (LS) may be falsely elevated in patients on maintenance hemodialysis (MHD) due to fluid overload. We measured LS change by transient elastography (TE) in MHD patients before and after successful renal transplantation., Method: Adults on ≥2 years of MHD, without additional risk factors for liver fibrosis or fluid overload, and planned for renal transplantation were prospectively recruited. LS was measured on two occasions, i.e., within two weeks before transplantation (pre-Tx LS) and after ≥ 3 months after successful transplantation (post-Tx LS). The participants with pre-Tx LS ≤ 7.0 KPa and >7.0 KPa were classified as "Group I" and "Group II," respectively. Categorical and numerical data are expressed as ratio/proportions and mean (SD), respectively., Results: Paired data from 43 participants (males 42 [97.7%]; age 32 [11] years) were analyzed. The pre-Tx and post-Tx LS of the entire cohort, measured at 307 (198) days of interval, were 8.5 (7.3) KPa and 6.7 (3.1) KPa, respectively. Before transplantation, 21 (49%) participants belonged to Group II and 22 (51%) to Group I. Among the Group II participants, 12 (57%) showed LS normalization after 312 (182) days of transplantation. Of the 22 participants in Group I, three (13.6%) showed LS elevation to >7.0 KPa after 303 (217) days of transplantation. The mean LS changes among the overall cohort, Group II, and Group I were -1.8 KPa, -4.1 KPa, and +0.2 KPa, respectively., Conclusion: LS in people on MHD may be falsely elevated, which is likely to normalize after successful renal transplantation., (© 2022 Indian National Association for Study of the Liver. Published by Elsevier B.V. All rights reserved.)

The author regrets that one of the author's name was incorrectly presented in the published version of this article. The third author's name original read as "Tajwar Singh Negi" this should have been "Tajwer Singh Negi".

The objectives of this prospective case-control study were to determine liver stiffness (LSM) by transient elastography (TE) in children with newly diagnosed chronic liver disease (CLD) and to find out normal values in healthy Indian children. Two groups (A: 50 CLD who underwent liver biopsy and B: 50 healthy) aged 5-18 years were recruited prospectively. Liver biopsies were scored as per Metavir scoring and compared with TE. The median age of 100 recruited children was 13.6 years. In group B, normal LSM was 4.9 (2.5-7.3) kPa with significantly higher LSM in adolescent males (5.6 (4.1-7.3) kPa) as compared with females (4.3 (3.7-4.9) kPa), p = 0.001. In group A, TE was excellent in discriminating significant fibrosis (≥ F2) (P = 0.001) at a cut-off value of 10.6 kPa with area under receiver operating characteristic curve of 0.96. Metavir fibrosis stage (β = 0.611; R2 = 0.586) and age (β = 0.230; R2 = 0.586) were independent variables associated with higher LSM in stepwise multiple logistic regression analysis.Conclusions: TE is an excellent non-invasive tool to assess significant liver fibrosis and can be used as an alternative to liver biopsy. Normative value of TE in adolescent males is higher than in females.What is Known:• Transient elastography is a good non-invasive test for liver fibrosis assessment.• Normal liver stiffness depends on race, gender, and age.What is New:• This is the first study from India to show the normative data of transient elastography in healthy Indian children.• We have documented that liver stiffness measurement by fibroscan in treatment naïve chronic liver disease has excellent correlation in significant fibrosis, severe fibrosis, and cirrhosis.

Hepatitis C virus (HCV) infection is a considerable public-health problem and an important cause of liver disease with about 71 million people infected worldwide and more than 399 000 people die every year from hepatitis C-related liver diseases. The present study was, therefore, initiated to investigate the association of polymorphism in interferon λ3 (IFNL3) also known as interleukin-28B (IL-28B) gene with chronic HCV infection and association of these polymorphic variants with the combination daclatasvir and sofosbuvir HCV therapy response. Genotypes were determined by the polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) assay in a total of 250 chronic HCV genotype three patients and 500 number of healthy controls. Our data revealed that the TT (minor) genotype of IFNL3 (rs12979860) and GG (minor) genotype of IFNL3 (rs8099917) exhibited a significant association with chronic HCV genotype 3 infection when compared with controls. The results of treatment response showed that CC (major) genotype of IFNL3 (rs12979860) and TT (major) genotype of IFNL3 (rs8099917) are associated with the likelihood of achieving a higher sustained virological response (SVR), to combined daclatasvir and sofosbuvir therapy, in genotype 3-infected HCV patients, whereas the individuals with TT (minor) genotype of IFNL3 (rs12979860) and GG (minor) genotype of IFNL3 (rs8099917) are more susceptible to chronic HCV infection and treatment relapse, suggesting a role of IFNL3 (rs12979860) and (rs8099917) in the treatment outcome of combined daclatasvir and sofosbuvir therapy in chronic HCV genotype 3 infection., (© 2018 Wiley Periodicals, Inc.)

Background: In a developing country like India with intermediate level of prevalence of hepatitis B, most of the patients remain undiagnosed as they are asymptomatic. The purpose of the study was to diagnose asymptomatic HBsAg positive patients from the general population and evaluate further the potential clinical implications of IDAHS., Methods: Asymptomatic subjects with unknown HBV status were screened free of cost for hepatitis-B surface antigen. Those who tested positive for HBsAg were further tested to identify those who were potential candidates for anti-viral therapy. To explore the relevance of our screening we assessed potential implications of HBsAg detection., Results: A total of 30,836 patients were screened in medical camps over the period of 7 years. Out of these 704 (2.3%) subjects were found to be positive for HBsAg. Distress of being diagnosed with HBV was expressed by 649 (92%) of the positive subjects. High cost of further testing and antiviral therapy, leading to inability to pursue further management was elicited in 510 (72%) of the positive subjects. HBV DNA was detected in 349 (59%) out of 592 subjects, out of which 236 (67%) had high viral load., Conclusion: Incidental detection of asymptomatic HBsAg positive subjects was seen in 2.3% of subjects. One third of these patients had an actively replicating virus and required antiviral therapy. Financial support was required in 72% of the subjects for further HBV management. Detecting HBsAg in asymptomatic person in an endemic community has considerable health and psycho-economic impact on the individual.

Background: India is home to one in 14 of all chronic hepatitis B virus (HBV) cases, meaning that it is important to develop HBV interventions that are applicable in the Indian context. Vaccination is the foremost tool for interrupting the HBV infection cycle. HBV vaccination was not included in India's government-sponsored expanded immunisation program until 2011, and many children born earlier remain unvaccinated. This study sought to observe the impact of the HOPE Initiative's school-based intervention to increase vaccination coverage by increasing HBV awareness among students in Lucknow, Uttar Pradesh., Methods: At 430 schools in the administrative areas within and surrounding Lucknow, students viewed an educational documentary film on HBV and completed two questionnaires, one immediately before the screening and the other six weeks later. Both questionnaires asked the same 14 questions, which were organized into five domains: knowledge of the magnitude of the problem of HBV; knowledge of modes of HBV transmission; knowledge of consequences of HBV infection; awareness of HBV; and attitudes regarding HBV. The baseline questionnaire also asked students whether they had been vaccinated against HBV. At two-year follow-up, researchers measured vaccination levels at a subset of 30 intervention schools and six non-intervention schools to further assess the impact of the intervention., Results: Baseline questionnaires were completed by 11,250 students, and post-intervention questionnaires, by 9698 students. Scores for knowledge about the magnitude of the HBV problem improved from 41% at baseline to 74% at follow-up, and scores for knowledge about modes of transmission, from 38% to 75% ( p  < 0.05 for both). The baseline HBV vaccination level among students receiving the intervention was 21%. Two years after the intervention, 45% of students ( N  = 4284) reported being vaccinated at intervention schools compared to 22% ( N  = 1264) at non-intervention schools., Conclusions: The observed increases in HBV awareness, knowledge and vaccination levels in this study indicate that school-based interventions can be used to achieve higher vaccination coverage among Indian children. The documentary film was found to be an affordable tool for reaching large audiences. More studies are needed to validate the impact of this intervention and to explore its applicability to other social causes.

Background and Aim: Genetic factors regulating alcohol metabolism could predispose in developing alcoholic pancreatitis (ACP). Studies revealed that alcohol could be metabolized by both ways, oxidative and non-oxidative. The main oxidative pathway includes alcohol dehydrogenase (ADH), aldehyde dehydrogenase (ALDH), and cytochrome P450 enzyme. We investigated the association of polymorphisms in these enzymes with the alcoholic pancreatitis in the north Indian population., Method: Patients with alcoholic pancreatitis (ACP; n = 72), tropical calcific pancreatitis (TCP; n = 75), alcoholic controls (AC; n = 40), and healthy controls (HC; n = 100) were included in the study. Blood samples were collected from the subjects in EDTA coated vials. DNA was extracted and genotyping for ADH3, ALDH2, and CYP2E1 was done by PCR-RFLP (polymerase chain reaction-restriction fragment length polymorphism). The products were analyzed by gel electrophoresis., Result: The frequency distribution of ADH3(*)1/(*)1 genotype was significantly higher in ACP group (59.7%) compared with TCP (38.7%), HC (42%), and AC (37.5%) and was found to be associated with increased risk of alcoholic pancreatitis. There was no statistically significant difference between the frequency distribution of ADH3(*)1/(*)1, ADH3(*)1/(*)2, and ADH3(*)2/(*)2 genotypes between TCP and HC or healthy alcoholics. ALDH2 gene was monomorphic in our population, and the frequencies for CYP2E1 intron 6 Dra I polymorphism were comparable in all the four groups., Conclusion: This study shows that carriers of ADH3(*)1/(*)1 individuals consuming alcohol are at higher risk for alcoholic pancreatitis than those with other genotypes such as ADH3(*)1/(*)2 and ADH3(*)2/(*)2.

We conducted a case-control study involving 150 genotype 3 chronic hepatitis C virus (HCV) patients and 150 healthy controls to investigate the association of polymorphisms in the interleukin-10 (IL-10) gene with chronic HCV infection and the association of these polymorphic variants with the combination of pegylated interferon (Peg-IFN) and ribavirin therapy response. Our data revealed that the GG genotype of IL-10 -1082A/G exhibited significant association with genotype 3 chronic HCV infection compared to controls. Treatment response data also showed a significant increase in risk for the GG genotype of IL-10 -1082A/G in response-relapse patients or non-responder patients compared to sustained virological response patients. Further, a significant increase in risk was also revealed for the CC genotype of IL-10 -592A/C in response-relapse patients or non-responder patients compared to sustained virological response patients, suggesting a role of the GG genotype of IL-10 -1082A/G and CC genotype of IL-10 -592A/C in the treatment outcome of combined Peg-IFN/ribavirin therapy.

Background: Mutations in p53 gene are found in a majority of human malignancies and usually occur in the exons 5, 6, 7 and 8. Mutated p53 protein is more stable and gets accumulated in the cells that induce the host to develop anti-p53 antibodies in sera of cancer patients., Aim: This study is aimed to observe the frequency and nature of mutations in exons 5-8 of p53 gene and to evaluate its correlation with prevalence of serum p53 antibodies in Indian patients with gallbladder cancer (GBC)., Methods: Mutation studies were done in cancer tissues obtained from 62 patients with proven GBC (40 cytologically proven cases and 22 resected gallbladder cancer tissues) by polymerase chain reaction (PCR), restriction fragment length analysis (RFLP) and single strand conformation polymorphism (SSCP). Presence of serum p53 antibodies was determined using highly specific enzyme linked immunosorbent assay (ELISA) kit in 50 patients with GBC and 30 patients of cholelithiasis. Clinicopathologic characteristics of these patients were given attention., Results: Antibodies to p53 protein was present in the serum in 34% (17/50) of GBC patients and in 3.3% (1/30) patients with cholelithiasis (p < 0.018). RFLP failed to detect common mutations in the exons 5- 8 of the p53 gene in 62 samples. Using SSCP analysis we could detect frameshift mutation in p53 gene in 2 of 22 (9.1%) GBC cases. Mutated samples were sequenced and found to have insertion of adenine at codon 271 (GAG) in exon 8 region., Conclusion: Our results show that 1//3rd of the north Indian patients with GBC have antibodies to p53 protein. The commonest identifiable alteration in the p53 gene was a frameshift mutation at codon 271.

Background and Aims: Microlithiasis has been suspected to cause acute pancreatitis and biliary pain. We studied the frequency of microlithiasis and response to treatment in recurrent idiopathic acute pancreatitis (RIAP) and unexplained biliary pain., Methods: Gallbladder bile was examined microscopically for cholesterol monohydrate crystals (CMC) and calcium bilirubinate granules (CBG) in patients with RAIP (n = 24; mean age 36 years, range 18-56 years; 14 men), unexplained biliary pain (n = 12; mean age 32 years, range 22-55 years; six men), gallstones (n = 22; mean age 40 years, range 30-58 years; 12 men) and patients without clinical or imaging evidence of gallstone disease (n = 12; mean age 32 years, range 14-54 years; six men). The presence of a single CMC or >25 CBG/slide was considered abnormal., Results: Bile microscopy was abnormal in 75% patients with RAIP (18/24; CMC in 10, CBG in six, CMC and CBG in two), 83.3% patients with unexplained biliary pain (10/12; CMC in seven, CBG in one, CMC and CBG in two) and 95.4% patients with gallstones (21/22; CMC in 12, CBG in one, CMC and CBG in eight). None of the controls without gallstone disease had CMC while three patients had low counts of CBG. Twenty-eight patients with RAIP and biliary pain having microlithiasis agreed to be treated with cholecystectomy (n = 2), endoscopic sphincterotomy (n = 21) or ursodeoxycholic acid (UDCA; n = 5). The 23 patients treated with cholecystectomy or sphincterotomy remained asymptomatic during follow up (mean 23 months, range 6-48 months). Four of five patients treated with UDCA remained asymptomatic for a follow-up period of 9, 10, 11 and 18 months, respectively. One patient who had refused cholecystectomy or sphincterotomy continued to experience pain at the same frequency as before during a follow-up period of 12 months. One patient, who was asymptomatic on UDCA for 9 months, agreed to undergo sphincterotomy and remained asymptomatic over a follow-up period of 14 months., Conclusions: Microlithiasis is a common cause for idiopathic acute pancreatitis and unexplained biliary pain. Lasting relief is obtained in most patients after treatment with UDCA, cholecystectomy or sphincterotomy.

Background: Endoscopic sphincterotomy has been shown to inhibit stone formation in the gall bladder of experimental animals., Aims: To investigate the alterations in bile composition and gall bladder motility after endoscopic sphincterotomy., Patients: A study was performed of gall bladder bile composition and gall bladder motility in patients with gallstone disease ((n = 20; age 40-60 years, median age 55 years: seven men), with gall bladder calculi (n = 12) and with diseased gall bladder (chronic inflammation) without gall bladder calculi (n = 8)), who had received endoscopic sphincterotomy for common bile duct stones. Age and sex matched disease controls comprised 20 patients with gallstone disease but without stones and an intact sphincter of Oddi (with gall bladder calculi (n = 10) and diseased gall bladder without gall bladder calculi (n = 10))., Methods: Gall bladder motility was assessed by ultrasound. Duodenal bile collected by nasoduodenal tube after stimulation of gall bladder by intravenous ceruletid infusion was analysed for cholesterol, phospholipid, and bile acid concentrations, cholesterol saturation index, and nucleation time., Results: There was a significant reduction in mean (SEM) fasting volume (12.5 (1.7) ml v 26.4 (2.5) ml; p < 0.001) and mean (SEM) residual volume (4.34 (0.9) ml v 14.7 (0.98) ml; p < 0.001), and increase in mean (SEM) ejection fraction (65.7 (4.2)% v 43.6 (5.52)%; p < 0.001) and mean (SEM) rate constant of gall bladder emptying (-0.031/min v -0.020/min; p < 0.01) in patients who had been subjected to endoscopic sphincterotomy. Median nucleation time was significantly longer (17 days v 6 days; p < 0.006) in treated patients. There was a reduction in total mean (SEM) lipid concentrations (6.73 (0.32) g/dl v 7.72 (0.84) g/dl; p < 0.05), cholesterol (5.6 (1.5) mmol/l v 10.3 (2.23) mmol/l; p < 0.001) and CSI (0.72 (0.15) v 1.32 (0.31); p < 0.001). There was no significant change in mean (SEM) phospholipid (25.6 (3.5) mmol/l v 23.4 (6.28) mmol/l) and bile acid (93.7 (7.31) mmol/l v 105.07 (16.6) mmol/l) concentrations., Conclusions: After endoscopic sphincterotomy there was enhanced contractility of the gall bladder, accompanied by a prolongation of nucleation time and reduction in cholesterol saturation index.

A quick and reliable method for estimating the proportion of constituents of a stone may be useful in determining the prevalence of chemical type of gallstones in different geographic areas or ethnic groups. Chemical and infrared spectroscopy estimation facilities are not commonly available in many parts of the world and visual inspection may not be reliable for scientific purposes. To investigate whether identification of microcrystalline solids in partially dissolved stone powder could accurately predict the chemical nature of the gallstone we undertook a blind study on 40 samples of gallstones and compared our results with those of visual inspection and quantitative infrared spectroscopy. There were 29 cholesterol stones (mean cholesterol 83.4 +/- 7.5%), six intermediate cholesterol stones (mean cholesterol 48.0 +/- 21.2%) and five pigment stones (mean cholesterol 14.3 +/- 4.3%) as determined by quantitative infrared spectroscopy. Microscopic examination of partially dissolved gallstone powder in ethanol correctly identified all 29 cholesterol gallstones (sensitivity 100%, specificity 92%), four of six intermediate cholesterol stones (sensitivity 67%, specificity 100%) and all five pigment stones (sensitivity 100%, specificity 97%). It also detected microspheroliths of calcium carbonate in 14 of 16 calcium carbonate containing gallstones (sensitivity 88%, specificity 100%). The chemical grouping of stones on the basis of microscopic examination was correct in 37 (93%) of 40 samples and was especially useful in identifying 'intermediate' cholesterol stones which cannot be recognized by visual inspection. Thus microscopic examination of powdered gallstones appears to be a simple and reliable method of determining gallstone composition.

Cholesterol gallstones obtained from different geographic regions have been reported to show significant differences in their minor chemical constituents. We undertook the present study with two objectives: (i) to investigate the possible physiochemical and radiological differences between cholesterol gallstones obtained from Indian and German patients; and (ii) to compare the brittleness of the two stone groups. Forty Indian and 36 German gallstones (matched in size and shape) were subjected to assessment of physical characteristics, in vitro computed tomography (CT) and chemical analysis. German stones more often had a stone density distribution index of > or = 50 Hounsfield units (HU) (26 vs 14; P < 0.01), peripheral calcification (18 vs 9; P < 0.02), maximum CT density > or = 90 HU (17 vs 9; P < 0.05) and significant calcium carbonate (9 vs 5; P < 0.05), compared to Indian stones. The in vitro lithotripsy performed with the Siemens Lithostar Plus machine at a constant energy level showed the German stones to be more brittle (easy to fragment), more often requiring < 1000 shocks for fragmentation (25/36; 69%) compared to Indian stones (18/40; 45%, P < 0.05). Gallstones from different geographic regions may show significant variations in their physicochemical characteristics that may explain the differences in their brittleness to lithotripsy.

The high failure rate of contact litholytic therapy for common bile duct stones with currently available cholesterol solvents has been attributed to the inclusion of patients with pigment stones, as no pretreatment investigation is undertaken to distinguish the two stone types. In 36 patients with common bile duct stones we prospectively evaluated the utility of microscopic examination of bile collected from the biliary tree in predicting stone composition. The bile, obtained by means of either an endoscopically placed nasobiliary catheter (n = 27) or a surgically placed T-tube (n = 9), was subjected to microscopic examination, and findings were compared with the composition of stones retrieved subsequently. On the basis of quantitative infrared spectroscopy, stones were classified as cholesterol (n = 28) or pigment (n = 8) stones. The presence of cholesterol crystals in bile correctly identified 24 of 28 patients with cholesterol stones (sensitivity, 86%; specificity, 100%; positive predictive value, 100%). Calcium bilirubinate granules, when present alone (without cholesterol crystals), correctly identified all eight patients with pigment stones (sensitivity, 100%; specificity, 89%; positive predictive value, 73%). Thus, microscopic examination of bile from the biliary tree, if used as a pretreatment screening test, may help distinguish between patients with cholesterol and pigment stones and thereby considerably improve the results of litholytic therapy of common bile duct stones with currently available solvents.

Why some gallstones do not fragment easily to lithotripsy is unclear. The aim of the present study was to determine gallstone factors associated with resistance to fragmentation. Seventy-six cholesterol rich gallstones were subjected to physical evaluation, in vitro computed tomography, chemical analysis by infra red spectroscopy, and ultrastructural studies (of 26 matched stones) by scanning electron microscopy and energy dispersive X-ray microanalysis. In vitro lithotripsy was performed with the Siemens Lithostar Plus machine at a constant energy level. Of 76 stones, 33 required > 1000 shocks for effective fragmentation (largest diameter < or = 5 mm); they had significantly higher maximum diameter (P < 0.001), volume (P < 0.001), weight (P < 0.001) and lower stone density distribution (SDD) index (P < 0.05) and lower calcium bilirubinate content (P < 0.001) than those requiring < or = 1000 shocks. Large (> 15 mm; P < 0.05), round stones (P < 0.02) and gallstones with SDD index of < 50 HU (P < 0.02) and gallstones with SDD index of < 50 HU (P < 0.05) were more difficult to fragment. Clinical application of these parameters may help in better selection of patients for this non-surgical mode of therapy for gallstones.

The results of bile salt treatment in patients with radiolucent stones and a functioning gall bladder have been poor. In 42 of these patients awaiting cholecystectomy we determined the value of duodenal bile examination in predicting gall stone composition, and thus identifying those less likely to respond to bile salt therapy. Based on chemical analysis and scanning electron microscopy, 28 of 42 (67%) gall stones retrieved at surgery were potentially insoluble. Microscopic examination of duodenal bile correctly identified 21 (75%) of them: it predicted all four (100%) pigment stones, three of six (50%) calcium carbonate containing cholesterol stones, and 14 of 18 (78%) cholesterol stones with pigment shells. It was nearly as reliable as microscopic examination of bile aspirated directly from the gall bladder during surgery (21 (75%) v 23 (82%); p = NS). Furthermore, the presence of cholesterol crystals in duodenal bile was a more sensitive indicator than chemical detection of supersaturation (34 of 38 (89%) v 25 of 35 (71%); p < 0.05) for prediction of cholesterol gall stones. Microscopic examination of duodenal bile, if used as a screening test, could help to exclude potential non-responders and thereby improve considerably the results of oral bile salt treatment for gall stone dissolution.

Thirty-nine patients with cholelithiasis were prospectively studied to evaluate the qualitative and quantitative differences between duodenal bile and gallbladder bile. Duodenal bile obtained before cholecystectomy by nasoduodenal intubation and ceruletide injection was qualitatively similar to gallbladder bile obtained during surgery. Microscopic cholesterol crystals as an indicator of cholesterol gallstones (n = 35) could be detected in 31 (89%) and 35 (100%; p = NS), respectively. Moreover, there was no difference in the molar percentage of three biliary lipids and the mean cholesterol saturation index (1.54 +/- 0.72 and 1.74 +/- 0.42; p = NS) of the two sources of bile. Duodenal bile was, however, dilute as compared with gallbladder bile, as evidenced by lower cholesterol crystal counts (167 +/- 247 versus 705 +/- 978; p < 0.01), lower total lipid concentration (5.8 +/- 2.7 versus 11.1 +/- 5.6 g/dl; p < 0.001), and lower concentrations (in mmol/l) of the three bile lipids--that is, total bile acids, phospholipids and cholesterol (p < 0.001). Good concentrated bile (total lipid concentration > or = 5 g/dl) could be obtained in 74% of duodenal bile samples, compared with 90% of gallbladder bile (p = NS). Our study shows that, although duodenal bile is dilute as compared with gallbladder bile, it is qualitatively similar to gallbladder bile and, because of the ease and safety of its collection, can be used to study serial alterations in biliary composition in individual subjects.