Formulation Design and Optimization of Orodispersible Tablets of Quetiapine Fumarate by Sublimation Method.

The objective of present study was to formulate directly compressible orodispersible tablets of quetiapine fumarate by sublimation method with a view to enhance patient compliance. A full 3(2) factorial design was used to investigate the effect of two variables viz., concentration of Indion 414 and camphor. Indion 414 (3-5 % w/w) was used as superdisintegrant and camphor (5-15 % w/w) as subliming agent. The tablets were evaluated for thickness, weight variation, hardness, friability, content uniformity, wetting time, porosity, in vitro disintegration time and in vitro drug release. The formulation containing 5% w/w of Indion 414 and 5% w/w camphor was emerged as promising based on evaluation parameters. The disintegration time for optimized formulation was 18.66 s. The tablet surface was evaluated for presence of pores by scanning electron microscopy before and after sublimation. Differential scanning colorimetric study did not indicate any drug excipient incompatibility, either during mixing or after compression. The effect of independent variables on disintegration time, % drug release and friability is presented graphically by surface response plots. Short-term stability studies on the optimized formulation indicated no significant changes in drug content and in vitro disintegration time. The directly compressible orodispersible tablets of quetiapine fumarate with lower friability, greater drug release and shorter disintegration times were obtained using Indion 414 and camphor at optimum concentrations.

Phase II trial of cisplatin, interferon alpha-2b, doxorubicin, and 5-fluorouracil for biliary tract cancer.

The aim of this study was to test the efficacy of a chemotherapy combination of cisplatin, IFN alpha-2b, doxorubicin, Adriamycin, and 5-fluorouracil (PIAF) as treatment for radiologically measurable cancer of the biliary tree. Forty-one patients (19 gallbladder carcinoma and 22 cholangiocarcinoma) with unresectable, histologically confirmed adenocarcinoma were registered. Starting chemotherapy doses were as follows: cisplatin, 80 mg/m(2) i.v. over 2 h; doxorubicin, 40 mg/m(2) i.v. over 2 h; and 5-fluorouracil, 500 mg/m(2) by continuous infusion daily for 3 days. IFN alpha-2b (5 x 10(6) units/m(2)) was administered s.c. before the cisplatin and daily thereafter for a total of four doses. The overall response rate was 21.1% [95% confidence interval (CI), 10-37]. For cholangiocarcinoma and gallbladder carcinoma patients, the response rates were 9.5% (95% CI, 1-32%) and 35.3% (95% CI, 14-62%), respectively. Overall median survival time was 14 months (95% CI, 9.5-18.5), 18.1 months (95% CI, 12.1-24.1) for the cholangiocarcinoma patients, and 11.5 months (95% CI, 5.9-17.1) for the gallbladder carcinoma patients. This difference was not statistically significant. The most common grade III and IV toxicities were neutropenia (41%), thrombocytopenia (20%), nausea and vomiting (34%), and fatigue (20%). In conclusion, the PIAF combination seemed more active against gallbladder carcinoma than against cholangiocarcinoma but was associated with significant toxicity. Therefore, this regimen cannot be recommended for cholangiocarcinoma, but it may have a role in the treatment of gallbladder carcinoma, particularly among patients who were refractory to higher priority investigational agents.

Expression of IL-15 and IL-4 in IFN-gamma-independent control of experimental human Cryptosporidium parvum infection.

We have previously demonstrated interferon gamma (IFN-gamma) in intestinal mucosa after experimental human Cryptosporidium parvum infection, but expression was limited to sensitized volunteers. To characterize IFN-gamma-independent mechanisms in control of infection, jejunal biopsies from immunocompetent volunteers experimentally challenged with C. parvum were examined by in situ hybridization for interleukin (IL-)15 and IL-4 mRNA with confirmation by immunohistochemistry. Cytokine expression was correlated with prechallenge anti- C. parvum IgG, symptoms, oocyst shedding, and prior IFN-gamma expression data. IL-15 expression was noted only in those without prior sensitization, who did not express IFN-gamma. By contrast, expression of IL-4 was associated with prior sensitization. IL-15 was only detected in those with symptoms (6/14 symptomatic vs 0/3 asymptomatic, P<0.05). Among 14 volunteers who did not express IFN-gamma, oocyst shedding was lower in those expressing IL-15. Overall, 14/15 volunteers who did not shed oocysts expressed either IFN-gamma or IL-15. There was no correlation between expression of IL-4 and symptoms or oocyst shedding. In conclusion, IL-15 expression was associated with control of oocyst shedding in those not expressing IFN-gamma. These data suggest that IL-15 is involved in IFN-gamma independent mechanisms of control of human cryptosporidiosis, perhaps via activation of the innate immune response.

Combining gemcitabine with radiation in pancreatic cancer: understanding important variables influencing the therapeutic index.

We compared and evaluated available laboratory and clinical data on the use of concurrent gemcitabine (Gemzar; Eli Lilly and Company, Indianapolis, IN) and radiation in pancreatic cancer to provide guidance for subsequent prospective research initiatives. Preclinical data suggest that the timing of administration of gemcitabine with respect to radiotherapy is important, but this issue has not yet been confirmed by clinical data. Phase I clinical data indicate that the amount of acute toxicity from the combination of gemcitabine and radiotherapy is strongly related to the dose and schedule of administration of gemcitabine, as well as to the radiation field size. There also appears to be an inverse linear relationship between the maximum tolerated gemcitabine dose and radiation dose. Also important, but less clear, is the infusion rate of gemcitabine as it relates to the systemic efficacy of the drug. The combination of additional agents with gemcitabine and radiation appears to be feasible. Finally, the addition of radioprotectors may enable chemotherapy dose escalation, but safe escalation of the radiotherapy dose with newer techniques has not been established. Semin Oncol 28 (suppl 10):25-33.

A three-step strategy of induction chemotherapy then chemoradiation followed by surgery in patients with potentially resectable carcinoma of the esophagus or gastroesophageal junction.

BACKGROUND: Patients with locoregional carcinoma of the esophagus or gastroesophageal junction have a poor survival rate after surgery. Preoperative chemotherapy or chemoradiotherapy has not improved the outcome for these patients. Our study was designed to assess the feasibility of preoperative induction combination chemotherapy in addition to chemoradiotherapy to improve the curative resection rate, local control, and survival. PATIENTS AND METHODS Patients having histologic proof of localized carcinoma (either squamous cell carcinoma or adenocarcinoma) of the esophagus or gastroesophageal junction underwent full classification including endoscopic ultrasonography (EUS). Patients first received up to two courses of induction chemotherapy consisting of 5-fluorouracil at 750 mg/m(2)/day as continuous infusion on Days 1--5, cisplatin at 15 mg/m(2)/day as an intravenous bolus on Days 1--5, and paclitaxel at 200 mg/m(2) as a 24-hour intravenous infusion on Day 1. The second course was repeated on Day 29. This was followed by radiotherapy (45 grays in 25 fractions) and concurrent admission of 5-fluorouracil (300 mg/m(2)/day as a continuous infusion 5 days/week) and cisplatin (20 mg/m(2) on Days 1--5 of radiotherapy). After chemoradiotherapy, patients underwent surgery. The feasibility of this approach, curative resection rates, patient survival, and patterns of failure were assessed. RESULTS: Thirty-seven of 38 patients enrolled were evaluable for toxicity and survival. Adenocarcinoma and distal esophageal location of carcinoma were observed frequently. Thirty-five (95%) of the 37 patients underwent surgery, all of whom had an R0 (curative) resection. A pathologic complete response was noted in 11 (30%) of the 37 total patients. In addition, 5 patients (14%) had only microscopic carcinoma. According to EUS classification, 31 (89%) of the 35 patients who underwent surgery had a T3 carcinoma whereas according to pathologic classification only 3 (9%) had a T3 carcinoma (P

DNA image analysis combined with routine cytology improves diagnostic sensitivity of common bile duct brushing.

BACKGROUND: Cytologic evaluation of common bile duct brushings has a low sensitivity for diagnosing malignancy because of scant cellularity, poor cellular preservation, or sampling errors occur. The aim of this study was to evaluate whether cytology combined with image analysis improves the diagnostic accuracy of bile duct brushing in comparison with cytology alone. METHODS: Forty-nine specimens of bile duct brushings obtained from 45 patients during endoscopic retrograde cholangiopancreatography were evaluated using cytology and image analysis. Specimens were classified as negative, atypical, suspicious, or malignant by using cytologic evaluation. DNA histograms were classified as diploid (D), broad diploid (BD), aneuploid (A), or tetraploid (T). Degree of hyperploidy (DH), representing cells with a DNA content > 5C was evaluated using a cutoff value of > or = 1%. Final diagnosis of cancer was based on tissue specimens that were obtained by fine-needle aspiration or surgical biopsy and clinical fol- low-up. RESULTS: Thirty-four patients ultimately proved to have a malignancy. Cytology revealed 19 negative cases, 15 atypical cases, 9 suspicious cases, and 6 malignant cases. Together, suspicious and malignant cytology cases yielded a sensitivity of 44% and a specificity of 100% for a cytologic diagnosis of cancer. The DNA histogram pattern was D in 24 cases, BD in 9 cases, and A in 16 cases. BD and A patterns were significantly associated with malignancy (P < 0.001). A DH > or = 1% was noted in 22 cases. DH alone had a sensitivity of 62% and a specificity of 91% and was significantly associated with malignancy (P < 0.004). Atypical cytology alone had a false-negative rate of 29%, but in combination with a DH > or = 1%, the false-negative rate decreased to 7%. Additionally, when the authors combined atypical, suspicious, and malignant cytology with a DH > or = 1%, the diagnostic sensitivity increased to 88%, but the specificity decreased to 73%. CONCLUSIONS: Combined cytology and image analysis of bile duct brushing increased diagnostic sensitivity compared with cytology alone. The findings suggest that image analysis may help select patients having atypical cytology who should undergo a more rigorous evaluation for malignancy. A larger prospective study of the usefulness of combined cytology and image analysis of bile duct brushing is warranted.

Effect of preoperative biliary decompression on pancreaticoduodenectomy-associated morbidity in 300 consecutive patients.

OBJECTIVE: To examine the relationship between preoperative biliary drainage and the morbidity and mortality associated with pancreaticoduodenectomy. SUMMARY BACKGROUND DATA: Recent reports have suggested that preoperative biliary drainage increases the perioperative morbidity and mortality rates of pancreaticoduodenectomy. METHODS: Peri-operative morbidity and mortality were evaluated in 300 consecutive patients who underwent pancreaticoduodenectomy. Univariate and multivariate logistic regression analyses were done to evaluate the relationship between preoperative biliary decompression and the following end points: any complication, any major complication, infectious complications, intraabdominal abscess, pancreaticojejunal anastomotic leak, wound infection, and postoperative death. RESULTS: Preoperative prosthetic biliary drainage was performed in 172 patients (57%) (stent group), 35 patients (12%) underwent surgical biliary bypass performed during prereferral laparotomy, and the remaining 93 patients (31%) (no-stent group) did not undergo any form of preoperative biliary decompression. The overall surgical death rate was 1% (four patients); the number of deaths was too small for multivariate analysis. By multivariate logistic regression, no differences were found between the stent and no-stent groups in the incidence of all complications, major complications, infectious complications, intraabdominal abscess, or pancreaticojejunal anastomotic leak. Wound infections were more common in the stent group than the no-stent group. CONCLUSIONS: Preoperative biliary decompression increases the risk for postoperative wound infections after pancreaticoduodenectomy. However, there was no increase in the risk of major postoperative complications or death associated with preoperative stent placement. Patients with extrahepatic biliary obstruction do not necessarily require immediate laparotomy to undergo pancreaticoduodenectomy with acceptable morbidity and mortality rates; such patients can be treated by endoscopic biliary drainage without concern for increased major complications and death associated with subsequent pancreaticoduodenectomy.

Evaluating the child for sexual abuse.

Child victims of sexual abuse may present with physical findings that can include anogenital problems, enuresis or encopresis. Behavioral changes may involve sexual acting out, aggression, depression, eating disturbances and regression. Because the examination findings of most child victims of sexual abuse are within normal limits or are nonspecific, the child's statements are extremely important. The child's history as obtained by the physician may be admitted as evidence in court trials; therefore, complete documentation of questions and answers is critical. A careful history should be obtained and a thorough physical examination should be performed with documentation of all findings. When examining the child's genitalia, it is important that the physician be familiar with normal variants, non-specific changes and diagnostic signs of sexual abuse. Judicious use of laboratory tests, along with appropriate therapy, should be individually tailored. Forensic evidence collection is indicated in certain cases. Referral for psychologic services is important because victims of abuse are more likely to have depression, anxiety disorders, behavioral problems and post-traumatic stress disorder.

Comparison of the urine-based ligase chain reaction test to culture for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in pediatric sexual abuse victims.

BACKGROUND: The urine-based ligase chain reaction (LCR) assay for Chlamydia trachomatis and Neisseria gonorrhoeae is an attractive alternative to culture because of the relative ease with which specimens may be collected, transported and processed. In addition LCR offers superior sensitivity while maintaining high specificity when compared with culture in various studies of adolescents and adults. A study comparing LCR to culture has not been published concerning children. METHODS: We conducted a prospective, comparison trial of the urine-based LCR test for Chlamydia trachomatis and Neisseria gonorrhoeae as compared with culture among children at a specialized referral center for evaluation for alleged sexual assault. Of the 1,010 children presenting to the center during the study period, 164 met the study requirements for risk of a sexually transmissible disease and collection of both culture and urine LCR specimens. RESULTS: Eight specimens tested positive by both methods for C. trachomatis. Another 10 specimens tested positive for C. trachomatis by LCR but were negative by culture. No patient with a negative LCR for C. trachomatis had a positive culture. For N. gonorrhoeae 2 specimens tested positive by both methods, and 3 specimens tested positive by LCR but negative by culture. No patient with a negative LCR for N. gonorrhoeae had a positive culture. CONCLUSIONS: The low prevalence of disease in the study population precluded statistical analysis. LCR may prove to be as specific and more sensitive than culture for the detection of C. trachomatis and N. gonorrhoeae in children. Further studies are needed.

Adenovirus in cancer therapy: a gastrointestinal case study.

Approved clinical trials involving gene therapy have been taking place for less than 10 years. As more knowledge is gained about genetics and disease, nurses must have a fundamental understanding of what genes do, how gene therapy is administered, and the risks and potential benefits of treatment. New methods for the administration of adenoviral vectors for cancer treatment in the endoscopy lab are currently being developed. By staying abreast of new treatment methods using gene or viral therapy, the gastrointestinal nurse can actively participate in clinical trials. A basic background of genetics and gene therapy in cancer is discussed. Safety issues and nursing implications regarding the administration and recovery of patients following gene therapy in the GI endoscopy lab are also addressed. An actual case study of a patient who participated in a study utilizing an attenuated adenovirus as investigational therapy for pancreatic adenocarcinoma is presented.

Transforming growth factor beta1 is expressed in the jejunum after experimental Cryptosporidium parvum infection in humans.

Biopsies from volunteers challenged with Cryptosporidium parvum were examined for transforming growth factor beta1 (TGF-beta1). None of the prechallenge biopsies exhibited TGF-beta. Seven of 12 volunteers with oocyst shedding expressed TGF-beta versus 2 of 13 volunteers without detected oocysts. The association of TGF-beta expression with oocyst excretion and the timing of symptoms suggests that TGF-beta mediates intestinal healing.

Evaluation of sexual abuse in the pediatric patient.

Evaluating a patient for suspected child sexual abuse can be daunting for many pediatric primary care practitioners. The consequences of misdiagnosis can be devastating. Knowledge of common clinical presentations, both physical signs and symptoms and behavioral changes, is paramount. Sexual abuse allegations must be reported and investigated by child protection agencies or law enforcement. Practitioners must be aware of when and how to report suspected child sexual abuse, in addition to having a basic understanding of the medical examination and findings. With a caring, knowledgeable, and sensitive approach to allegations of sexual abuse, the practitioner can assist the child and his or her family through this very difficult process.

Obliteration of esophageal varices using EUS-guided sclerotherapy with color Doppler.

BACKGROUND: The current standard treatment of bleeding esophageal varices is band ligation. Although endoscopic sclerotherapy has largely been supplanted by band ligation, there are still clinical situations in which injection methods are useful. Endoscopic ultrasound (EUS) may allow for a more complete evaluation of esophageal varices and perforating veins and may allow for more effective delivery of sclerosant. Our aim was to evaluate the use of color Doppler EUS-guided sclerotherapy for the obliteration of esophageal varices. METHODS: Five patients with esophageal varices (Child's A = 1, B = 2, C = 2) underwent dynamic EUS-guided sclerotherapy with color flow Doppler. EUS sclerotherapy was performed using Varijet (2.5 mm catheter) injector needles and sodium morrhuate directed at the perforating vessels until flow was completely impeded (2 to 4 mL per injection site). Data collected included (1) sessions to obliteration, (2) episodes of recurrent bleeding, (3) complications, and (4) mortality. RESULTS: Patients undergoing EUS-sclerotherapy required 2.2 sessions to achieve obliteration of varices. No patient had a recurrence of bleeding and no deaths occurred. One patient developed an esophageal stricture that responded to balloon dilation. CONCLUSIONS: Dynamic EUS-guided sclerotherapy with color flow Doppler may be safely and effectively used for the treatment of esophageal varices. It allows for effective delivery of sclerosant with favorable outcomes. Prospective, multicenter, randomized trials are warranted.

Preoperative chemoradiation for patients with pancreatic cancer: toxicity of endobiliary stents.

PURPOSE: A recent multicenter study of preoperative chemoradiation and pancreaticoduodenectomy for localized pancreatic adenocarcinoma suggested that biliary stent-related complications are frequent and severe and may prevent the delivery of all components of multimodality therapy in many patients. The present study was designed to evaluate the rates of hepatic toxicity and biliary stent-related complications and to evaluate the impact of this morbidity on the delivery of preoperative chemoradiation for pancreatic cancer at a tertiary care cancer center. PATIENTS AND METHODS: Preoperative chemoradiation was used in 154 patients with resectable pancreatic adenocarcinoma (142 patients, 92%) or other periampullary tumors (12 patients, 8%). Patients were treated with preoperative fluorouracil (115 patients), paclitaxel (37 patients), or gemcitabine (two patients) plus concurrent rapid-fractionation (30 Gy; 123 patients) or standard-fractionation (50.4 Gy; 31 patients) radiation therapy. The incidences of hepatic toxicity and biliary stent-related complications were evaluated during chemoradiation and the immediate 3- to 4-week postchemoradiation preoperative period. RESULTS: Nonoperative biliary decompression was performed in 101 (66%) of 154 patients (endobiliary stent placement in 77 patients and percutaneous transhepatic catheter placement in 24 patients). Stent-related complications (occlusion or migration) occurred in 15 patients. Inpatient hospitalization for antibiotics and stent exchange was necessary in seven of 15 patients (median hospital stay, 3 days). No patient experienced uncontrolled biliary sepsis, hepatic abscess, or stent-related death. CONCLUSION: Preoperative chemoradiation for pancreatic cancer is associated with low rates of hepatic toxicity and biliary stent-related complications. The need for biliary decompression is not a clinically significant concern in the delivery of preoperative therapy to patients with localized pancreatic cancer.

Interferon-gamma expression in jejunal biopsies in experimental human cryptosporidiosis correlates with prior sensitization and control of oocyst excretion.

To investigate the role of interferon (IFN)-gamma in human cryptosporidiosis, jejunal biopsies from experimentally infected volunteers and chronically infected AIDS patients were examined for IFN-gamma expression by in situ hybridization. IFN-gamma expression was compared with oocyst excretion, baseline serum anti-Cryptosporidium antibody, and symptoms. IFN-gamma mRNA was detected in biopsies from 13 of 26 volunteers after experimental infection but not in biopsies taken before C. parvum exposure or in biopsies from patients with AIDS-associated cryptosporidiosis. After challenge, 9 of 10 volunteers with baseline C. parvum antibody produced IFN-gamma, compared with 4 of 16 volunteers without baseline antibody (P<.01). Furthermore, IFN-gamma mRNA was detected in 9 of 13 volunteers who did not excrete oocysts, compared with 4 of 13 with organisms (P<.05). Thus, expression of IFN-gamma in the jejunum was associated with prior sensitization and absence of oocyst shedding. IFN-gamma production may explain the resistance to infection noted in sensitized persons but may not be involved in control of human primary infection.

Gastroesophageal junction adenocarcinoma.

The incidence rate of adenocarcinoma of the esophagogastric junction (AEG) is increasing in association with the epidemiologic rise in distal esophageal adenocarcinoma and gastric cardial (AEG type III) tumors. The overall survival rate is poor in most patients with AEG because lymph node or visceral metastases are frequently present at the time patients become symptomatic. A few patients are identified early in the disease because of screening for gastroesophageal reflux and Barrett's esophagus. Early stage AEG (T1N0 or T2NO, carcinoma in situ, or severe dysplasia ) can in many instances be cured with surgery alone. Ablative treatments for early stage AEG, including endoscopic fulguration by cautery and laser or photodynamic therapy, are investigational at this time. Locoregionally advanced AEG (T3, T4, N1, or M1a ) without distant systemic metastases (M1b) has a poor overall survival rate with surgery alone or definitive chemotherapy and radiation therapy without surgery. Analysis of the use of multimodality treatment strategies for locoregionally advanced AEG types I and II have demonstrated improved survival rates in two small phase III trials with preoperative concurrent chemoradiotherapy followed by surgical resection. In contrast, three small phase III trials with preoperative concurrent or sequential chemoradiotherapy in patients with predominantly squamous cell carcinoma did not demonstrate any clear survival advantage. Additionally, a randomized phase III study evaluating preoperative chemotherapy without radiation therapy in esophageal cancer (predominantly adenocarcinoma) has demonstrated no survival benefit. In light of these results, additional large randomized phase III studies are needed to confirm the potential benefit of preoperative concurrent chemoradiotherapy. At the present time, preoperative chemoradiotherapy remains investigational. For locoregionally advanced gastric adenocarcinoma, including AEG type III, postoperative concurrent 5-fluorouracil (5-FU)-based chemoradiotherapy is associated with improved survival as demonstrated in a recently completed random assignment trial (INT 0116). As a result, surgery with postoperative chemoradiotherapy has recently become the standard of care for patients with AJCC stage II and III gastric adenocarcinoma (including patients with AEG type III). Metastatic AEG (M1b) should be treated with palliative chemotherapy (in good performance patients) or supportive care (poor performance) in asymptomatic patients. Radiation therapy and endoscopic stent placement (expandable wire mesh) can be used to palliate dysphagia in patients with M1b disease. The development of expandable stents and improved radiotherapy has obviated surgical bypass to palliate patients with symptomatic, metastatic AEG.

Cytologic features of lymphoepithelial cyst of the pancreas: two preoperatively diagnosed cases based on fine-needle aspiration.

We describe the cytologic features seen in fine-needle aspiration (FNA) specimens from two cases of preoperatively diagnosed lymphoepithelial cyst (LEC) of the pancreas. Pancreatic LEC is a rare, true cyst of uncertain histogenesis that may clinically and radiologically mimic a pseudocyst or cystic neoplasm. Both our patients were middle-aged men who presented with vague abdominal pain. Computed tomography (CT) of the abdomen revealed a mass in or around the pancreas, and CT-guided percutaneous FNA (patient 1) and endoscopic ultrasound-guided FNA (patient 2) yielded paste-like yellow-gray material. Cytologic smears showed numerous anucleated squamous cells in a background of keratinous and amorphous debris. A few benign nucleated squamous cells and plate-like cholesterol crystals were also seen. Unlike LEC of the head and neck region, only rare lymphocytes and histiocytes were present. Pancreatic LEC was diagnosed based on these cytologic findings and was histologically confirmed following cyst enucleation (patient 1) and partial pancreatectomy (patient 2). We conclude that preoperative FNA and recognition of the characteristic cytologic pattern will enable conservative surgical management of pancreatic LEC. Diagn. Cytopathol. 1999;21:346-350.

Evaluation of metastatic celiac axis lymph nodes in patients with esophageal carcinoma: accuracy of EUS.

BACKGROUND: Endosonography (EUS) is the most accurate modality for assessing depth of tumor invasion and local lymph node metastasis. However, its accuracy in the identification of metastatic (celiac axis) lymph nodes is less well defined. Our objective in this study was to determine the accuracy of Eus in detecting celiac axis lymph node metastasis in patients with esophageal carcinoma. METHODS: Two hundred fourteen patients with esophageal carcinoma underwent preoperative EUS. Of these, 145 underwent attempted surgical resection and staging, and 4 underwent EUS-guided fine-needle aspiration of mediastinal and celiac lymph nodes. Local (mediastinal) and distant (celiac axis) lymph nodes were assessed for malignancy on the basis of four criteria (larger than 1 cm, round, homogeneous echo pattern, sharp borders). Accuracy of EUS was determined by means of correlating histopathologic findings for the resected lymph nodes or results of EUS-guided fine-needle aspiration cytologic examination. RESULTS: Surgical exploration (n = 145) and fine-needle aspiration cytologic examination (n = 4) revealed metastatic celiac axis lymph nodes in 23 and metastatic mediastinal (local) lymph nodes in 93 of 149 patients with esophageal carcinoma. According to defined criteria for malignant lymph nodes, there were 19 true-positive and 4 falsenegative results. Sensitivity for the diagnosis of celiac lymph node metastasis with EUS was 83% with a 98% specificity. For the diagnosis of mediastinal lymph node metastasis, sensitivity was 79% and specificity was 63%. All patients with malignant celiac axis lymph nodes had local T3 (tumor breaching adventitia) or T4 (tumor invading adjacent organs) disease. CONCLUSION: EUS is an excellent modality in the evaluation of metastatic celiac axis lymph nodes in patients with esophageal carcinoma. These findings should be used in selecting options for treatment. Sensitivity for detecting malignancy is consistent with that of prior studies, and local and regional lymph nodes and specificity is significantly higher.