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Biomedical subjects

C Mel Wilcox

Publications and source records attributed to C Mel Wilcox.

At least 37 records · Page 2Linked to original sources

Patterns of use and public perception of over-the-counter pain relievers: focus on nonsteroidal antiinflammatory drugs.

OBJECTIVE: To assess the frequency and indications for over-the-counter (OTC) nonsteroidal antiinflammatory drug (NSAID) use and to what degree the public is aware of their side effects. METHODS: Two surveys totaling 9062 respondents were performed of the American public. The Roper survey, conducted in 1997, and the National Consumers League (NCL) survey, conducted in December 2002, were intended primarily to assess the public's use of and attitudes toward NSAID and OTC analgesics. RESULTS: Ibuprofen based drugs were the most frequently used OTC in both surveys (57% Roper, 33% NCL). In the Roper survey, 17% of respondents used NSAID, with 38% using both prescription and OTC. Forty-six percent of exclusive OTC users believed OTC were safer, while 56% of exclusive users of prescription NSAID believed they were safer. Sixty percent and 29% of exclusive OTC users were neither aware of nor believed they were at risk for side effects from NSAID, respectively. Twenty-six percent of respondents used more than the recommended dose on the label, while 22% believed warning symptoms would always precede any NSAID induced complications. In the NCL survey, 83% had used an OTC agent in the last year, with 15% reporting daily use, and 49% were not concerned about potential side effects. In this survey, 30% believed there was less risk with OTC analgesics, and 44% consumed more than the recommended dosage on the label. CONCLUSION: OTC analgesics including NSAID are widely used, are frequently taken inappropriately and potentially dangerously, and users are generally unaware of the potential for adverse side effects. Educational intervention directed toward both patients and physicians appears warranted.

Acetaminophen↗

Endoscopic ultrasound-guided fine-needle aspiration biopsy: a powerful tool to obtain samples from small lesions.

BACKGROUND: Endoscopic ultrasound (EUS) is a powerful imaging modality to identify and determine the extent of a lesion. In addition, EUS is superior to a computed tomography scan in detecting lesions < 3 cm. The objective of the current study was to determine whether small lesions (< or = 25 mm) affected the specimen adequacy and the diagnostic accuracy for lesions aspirated under EUS guidance. METHODS: In the current study, 209 consecutive EUS-guided fine-needle aspiration biopsy (EUS-FNAB) samples < or = 25 mm (100 samples) or > 25 mm (109 samples) as determined by EUS were obtained from 151 patients with a mean age of 62 years (range, 39-94 years). A cytopathologist present in the endoscopy suite determined specimen adequacy. Yield of adequate samples for diagnosis, number of passes, and operating characteristics of EUS-FNAB for small (< or = 25 mm) and large lesions (>25 mm) were compared. RESULTS: The overall yield of obtaining adequate samples for diagnosis was 96% (201 of 209). There was no difference noted with regard to the yield of obtaining samples (96% vs. 96%) from small or large lesions. A mean of 2.5 passes (range, 1-9 passes) was needed to obtain adequate samples from lesions < or = 25 mm, whereas a mean of 4.5 passes (range, 1-11 passes) was needed to obtain adequate samples from lesions > 25 mm. The sensitivity (96% vs. 96%), specificity (100% vs. 100%), and diagnostic accuracy (98% vs. 97%) for EUS-FNAB were comparable whether the lesion was < or = 25 mm or > 25 mm. CONCLUSIONS: EUS-FNAB was a highly effective technique to obtain samples from small (< or = 25 mm) and large (> 25 mm) lesions without affecting the sensitivity, specificity, or diagnostic accuracy.

Adult↗

EUS-guided FNA of the left adrenal gland in patients with thoracic or GI malignancies.

BACKGROUND: The diagnostic yield and safety of trans-gastric EUS-guided FNA of the left adrenal gland are not well defined. METHODS: All patients with an enlarged left adrenal gland on abdominal imaging and known or suspected malignancy referred to two EUS centers over a 3-year period were included in this study. EUS-guided FNA was performed on an outpatient basis by one of 4 experienced endosonographers. RESULTS: Thirty-one consecutive patients (21 men, 10 women; mean age 64.8 years) were evaluated. Tissue adequate for interpretation was obtained in all patients; no attempt to obtain tissue was unsuccessful. The median number of needle passes was 4.5 (range 1-8). No immediate complications were encountered. EUS-guided FNA confirmed malignant left adrenal involvement in 42% (13/31) of the patients. Patients with malignant left adrenal masses were more likely to have known cancer at another site (OR 12.0: 95% CI[1.6, 87.9]). Patients with benign masses were more likely to have preservation of the normal sonographic appearance of the adrenal gland ("seagull" configuration) compared with those with malignant masses (OR 9.8: 95% CI[1.9, 51.0]). The accuracy of EUS imaging based on size (> or =3 cm) alone was 81%: 95% CI[63, 93]). Of the patients with malignant adrenal masses, 85% (11/13) died or their clinical condition deteriorated during follow-up, while 15% (2/13) were being treated and were stable clinically. CONCLUSIONS: EUS-guided FNA of the left adrenal gland is a minimally invasive, safe, and highly accurate method that confirms or excludes malignant adrenal involvement in patients with thoracic or GI malignancies.

Adrenal Gland Neoplasms↗

Acute pancreatitis after EUS-guided FNA of solid pancreatic masses: a pooled analysis from EUS centers in the United States.

BACKGROUND: The aim of this study was to determine the frequency and the severity of pancreatitis after EUS-guided FNA of solid pancreatic masses. A survey of centers that offer training in EUS in the United States was conducted. METHODS: A list of centers in which training in EUS is offered was obtained from the Web site of the American Society for Gastrointestinal Endoscopy. Designated program directors were contacted via e-mail. The information requested included the number of EUS-guided FNA procedures performed for solid pancreatic masses, the number of cases of post-procedure pancreatitis, and the method for tracking complications. For each episode of pancreatitis, technical details were obtained about the procedure, including the location of the mass, the type of fine needle used, the number of needle passes, and the nature of the lesion. RESULTS: Nineteen of the 27 programs contacted returned the questionnaire (70%). In total, 4909 EUS-guided FNAs of solid pancreatic masses were performed in these 19 centers over a mean of 4 years (range 11 months to 9 years). Pancreatitis occurred after 14 (0.29%): 95% CI[0.16, 0.48] procedures. At two centers in which data on complications were prospectively collected, the frequency of acute pancreatitis was 0.64%, suggesting that the frequency of pancreatitis in the retrospective cohort (0.26%) was under-reported (p=0.22). The odds that cases of pancreatitis would be reported were 2.45 greater for the prospective compared with the retrospective cohort (95% CI[0.55, 10.98]). The median duration of hospitalization for treatment of pancreatitis was 3 days (range 1-21 days). The pancreatitis was classified as mild in 10 cases, moderate in 3, and severe in one; one death (proximate cause, pulmonary embolism) occurred after the development of pancreatitis in a patient with multiple comorbid conditions. CONCLUSIONS: EUS-guided FNA of solid pancreatic masses is infrequently associated with acute pancreatitis. The procedure appears to be safe when performed by experienced endosonographers. The frequency of post EUS-guided FNA pancreatitis may be underestimated by retrospective analysis.

Acute Disease↗

Technical outcomes and complications of ERCP in children.

BACKGROUND: The aim of this study was to compare the success and complications of diagnostic and therapeutic ERCP in children (age <18 years) and adult patients. METHODS: A retrospective case-controlled study was conducted in which all children undergoing ERCP at two centers (1994-2002) were identified from endoscopy databases and were matched with adult patients for all variables (e.g., indication, procedure complexity) except age. Outcomes with regard to technical success and complications were compared between the adult and the pediatric cohorts. Grade of procedure complexity and procedure-related complications were defined by using established criteria. RESULTS: A total of 116 children (mean age 9.3 years, range 1 month to 17 years; median age 8.1 years) and 116 matched adult patients (mean age 56.3 years, range 20-83 years; median age 49.7 years) underwent 163 and 173 ERCP procedures, respectively. According to procedure complexity grade, each group included the same number of patients, grade I, 72 patients; grade II, 12 patients; and grade III, 32 patients. Procedure success rate was 97.5% in children vs. 98% in the adult cohort (p= not significant). The complication rate was not significantly different between children and adult patients (3.4% vs. 2.5%). Most complications were of mild severity and encountered only in patients who underwent grade III procedures, with the exception of a single adult in whom moderate post-sphincterotomy bleeding developed after extraction of a large bile duct stone (grade II complexity). CONCLUSIONS: When ERCP is performed in children by expert endoscopists, the success rate is high and the complication rate is low, both being comparable with those for ERCP in adult patients.

Adolescent↗

Endoscopic ultrasound-guided fine needle aspiration biopsy of suspected cholangiocarcinoma.

BACKGROUND AND AIMS: Despite advances in endoscopic techniques for sampling bile duct strictures, the diagnosis of cholangiocarcinoma remains a challenge. The purpose of this study was to evaluate the yield of EUS-FNA and its impact on patient management for patients with suspected cholangiocarcinoma. METHODS: All patients undergoing EUS for the evaluation of suspected malignant biliary strictures were prospectively evaluated over a 23-month period. A single gastroenterologist performed all EUS-FNAs in the presence of a cytopathologist. Reference standard for final diagnosis included surgery, death from disease, and clinical and/or imaging follow-up. RESULTS: Twenty-eight patients (mean age 67 years [SD +/- 11], 72% male) were evaluated. Most patients (91%) presented with obstructive jaundice, and all except 1 had nondiagnostic sampling of the biliary lesions either at ERCP (88%), percutaneous transhepatic cholangiogram (n = 2), and/or computed tomography-guided biopsy (n = 1). Sixty-seven percent (14/21) had no definitive mass seen on prior abdominal imaging studies. The mean tumor size by EUS was 19 mm x 16 mm with a median number of passes to diagnosis of 3 (range 1-7). The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 86%, 100%, 100%, 57%, and 88%, respectively. EUS-FNA had a positive impact on patient management in 84% of patients: preventing surgery for tissue diagnosis in patients with inoperable disease (n = 10), facilitating surgery in patients with unidentifiable cancer by other modalities (n = 8), and avoiding surgery in benign disease (n = 4). CONCLUSIONS: Given the apparent accuracy and safety of EUS with FNA for imaging bile duct mass lesions and for obtaining a tissue diagnosis in patients with suspected cholangiocarcinoma, this technology may represent a new approach to diagnosis especially when other methods fail. The ability to obtain a definite diagnosis has a significant impact on patient management.

Adult↗

Prospective comparison of brush cytology, viral culture, and histology for the diagnosis of ulcerative esophagitis in AIDS.

BACKGROUND & AIMS: The best method(s) for the diagnosis of esophageal ulcers in patients with acquired immune deficiency syndrome (AIDS) is unknown. METHODS: Over an 8-year period, all human immunodeficiency virus (HIV)-infected patients with a CD4 lymphocyte count of < or =250/mm(3) and an esophageal ulcer underwent a standard protocol consisting of 2 biopsy examinations for viral culture (shell vial technique), brushing for cytology with immunohistochemistry (IHC) for viral antigens, and 10 biopsy examinations of the ulcer base/edge for routine histology and IHC. The cause of ulcer was based on histologic findings and clinical and endoscopic follow-up evaluation after therapy. RESULTS: Forty patients with 48 episodes of ulcer were studied (mean age, 34 yr; 88% men; median CD4 lymphocyte count = 31 cells/mm(3); range, 0-250 cells/mm(3)). Six patients had more than one endoscopic examination documenting ulcer, and 2 patients had more than one cause of ulcer. The most common causes of ulcer were: idiopathic (IEU) 22, cytomegalovirus (CMV) 15, and gastroesophageal reflux disease 6. Viral culture was positive for herpes simplex in 3 of 3, but only 4 of 15 (27%) for CMV, and specificity of viral culture was 100%. Cytologic brushings were only positive in the patients with herpes simplex virus (HSV) or incidental Candida esophagitis. Viral cytopathic effect was apparent on routine histologic staining in each patient with viral esophagitis, and IHC confirmed the diagnosis in each patient. Follow-up evaluation disclosed no patient with a misdiagnosis based on histology. CONCLUSIONS: Viral culture and cytologic brushings add little to the evaluation of esophageal ulcers in patients with AIDS over multiple biopsy specimens with routine histology.

Acquired Immunodeficiency Syndrome↗

Efficacy of the Za self-expandable metal stent for palliation of malignant biliary obstruction.

BACKGROUND: The efficacy and safety of the uncoated self-expandable Za metal stent for palliation of malignant distal biliary obstruction was prospectively analyzed. METHODS: Twenty-one patients with unresectable malignant tumors involving mid to distal common bile duct who presented with obstructive jaundice underwent endoscopic implantation of an uncoated self-expandable metal stent. Technical success with stent placement, adverse events, patient survival, duration of stent patency, and device performance were analyzed. RESULTS: Endoscopic biliary stenting was successful in all patients. No adverse events were encountered. The mean follow-up period of the 21 patients was 128 days (range, 3-263): 14 died of progressive disease at mean of 81 days (range, 3-210), 3 remain alive (at days 239, 250, and 263), and 4 were lost to follow-up (at days 90, 91, 92, and 116). The mean duration of stent patency was 249 days. Tumor ingrowth was observed in one patient (5%). Minor technical problems were encountered in 3 patients: 1 proximal deployment, 1 distal deployment, and difficulty associated with the delivery system in 1. CONCLUSIONS: The Za-metal stent provided effective palliation for patients with inoperable malignant biliary tumors. Although minor technical problems were encountered with stent deployment, the overall stent patency, efficacy, and safety profile appear satisfactory.

Aged↗

Patterns of bleeding after endoscopic sphincterotomy, the subsequent risk of bleeding, and the role of epinephrine injection.

BACKGROUND: The patterns of bleeding following endoscopic sphincterotomy (ES) and their predictive value for subsequent bleeding are poorly understood. Similarly, the efficacy and side effects of epinephrine (E) injection for persistent bleeding have not been well studied. METHODS: Over a 44-month period, all patients undergoing ES were prospectively assessed and followed-up. The character of bleeding (pulsatile, oozing, trickle, none) was recorded immediately, 5 minutes following ES and at the completion of the procedure. Patients with persistent bleeding at the time the procedure was completed (5 minutes or greater) received E injection(s) (1:10,000 concentrations) into the bleeding point with a sclerotherapy needle. ES was performed in all patients with a single electrosurgical generator Valleylab (Force 1B) using pure cutting current. RESULTS: 506 patients (68% females, mean age 54 years) who underwent 550 ES were studied. Bleeding patterns immediately following ES were: 6% pulsatile, 42% oozing, 27% trickle, and 24% none. E (median 0.5 cc; range 0.5-4 cc total) was injected during 79 procedures (14%); none of these patients had complications nor delayed bleeding. For all patients, delayed bleeding occurred in 8 (1.6%, 95% CI 0.57-0.0269); of these 8 delayed bleeders, 1 had no bleeding after ES, and only 1 had any bleeding at 5 minutes. The only variable associated with bleeding after ES was abnormal labs (thrombocytopenia, elevated creatinine concentration, hypoprothrombinemia). CONCLUSIONS: The pattern of bleeding following ES may not predict the risk of late bleeding. Abnormal labs are associated with visible bleeding. Epinephrine injection is safe and appears to provide effective hemostasis.

Adult↗

Re-examination of the cost-effectiveness of surgical versus medical therapy in patients with gastroesophageal reflux disease: the value of long-term data collection.

OBJECTIVES: For patients with reflux esophagitis, long-term therapeutic options include proton pump inhibitor (PPI) therapy and/or antireflux surgery. An earlier cost-effectiveness analysis concluded that at 5 yr, medical therapy was less expensive but similarly effective to fundoplication, but the results were sensitive to estimates on quality of life and long-term medication usage, which were derived from "expert opinion." Recently, data from randomized controlled trials addressing these variables have become available. We have incorporated these new data into a revised Markov model to examine the cost-effectiveness of surgical versus medical therapy in patients with severe reflux esophagitis. METHODS: A Markov simulation model was constructed using specialized software (DATA PRO 4.0, Williamstown, MA). Total expected costs and quality-adjusted life-years were calculated for long-term medical therapy and for laparoscopic Nissen fundoplication. Probabilities were obtained from the medical literature using Medline. Procedural and hospitalization costs used were the average Medicare reimbursements at our institution. Medication costs were the average wholesale price. The analysis was extended over a 10-yr time horizon at a discount rate of 3%. RESULTS: The discounted analysis shows that medical therapy is associated with total costs of 8,798 dollars and 4.59 quality-adjusted life-years, whereas the surgical strategy is more expensive (10,475 dollars) and less effective (4.55 quality-adjusted life-years). The results were robust to most one-way sensitivity analyses. CONCLUSIONS: Long-term medical therapy with proton pump inhibitors is the preferred strategy for patients with gastroesophageal reflux disease and severe esophagitis. Our study highlights the importance of using primary, patient-derived data rather than expert opinion.

Analysis of Variance↗

Gastrointestinal manifestations of AIDS.

Although gastrointestinal complications have decreased dramatically in patients with acquired immunodeficiency syndrome (AIDS) who received highly active antiretroviral therapy, these disorders still occur in those who do not seek healthcare, those with resistant virus, and those in developing countries where these drugs are not available. Opportunistic infections are the most frequent causes of gastrointestinal disease in patients with AIDS. A practical approach based on the character of the complaints and location of symptoms will help direct the most appropriate evaluation. In most patients, a diagnosis should be sought because effective antimicrobial therapy is available for most infections in these patients. When possible, improvement in immune function forms an integral part of the treatment regimen.

Journal Article↗

Yield of endoscopic ultrasound-guided fine-needle aspiration biopsy in patients with suspected pancreatic carcinoma.

BACKGROUND: Although atypical or suspicious cytology may support a clinical diagnosis of a malignancy, it is often not sufficient for the implementation of therapy in patients with pancreatic carcinoma. Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNAB) is a relatively new method for obtaining cytology samples, and one that may decrease the number of atypical/suspicious diagnoses. The goals of the current study were to prospectively evaluate the yield of EUS-FNAB in the diagnosis of patients presenting with solid pancreatic lesions and to evaluate the significance of atypical, suspicious, and false-negative aspirates. METHODS: All patients who presented with a solid pancreatic lesion and underwent EUS-FNAB over a 13-month period were included in the current study. One endoscopist performed all EUS-FNABs. On-site evaluation of specimen adequacy by a cytopathologist was available for each case. Follow-up included histologic correlation (n = 21) and clinical and/or imaging follow-up (n = 80), including 38 patients who died of the disease. RESULTS: EUS-FNABs were obtained from 101 patients (mean age, 62 +/- 11.8 years; age range, 34-89 years). The male-to-female ratio was 2:1. Sixty-five percent of the lesions were located in the head of the pancreas, 12% were located in the uncinate, 17% were located in the body, and 6% were located in the tail. The mean size of the tumors was 3.3 cm (range, 1.3-7 cm). A median of 4 needle passes were performed (range, 1-11 needle passes). Sixty-two biopsies (61.4%) were interpreted as malignant on cytologic evaluation, 5 (5%) as suspicious for a malignancy, 6 (5.9%) as atypical/indeterminate, and 26 (25.7%) as benign processes. Of the 76 malignant lesions, 71 were adenocarcinomas, 3 were neuroendocrine tumors, 1 was a lymphoma, and 1 was a metastatic renal cell carcinoma. All except one of the suspicious/atypical aspirates were subsequently confirmed to be malignant. Agreement was complete for the atypical cases. Among the suspicious cases, 2 of the 5 were identified as carcinoma by one cytopathologist and as suspicious lesions by the other, yielding a 40% disagreement rate between the 2 cytopathologists. Therefore, for the 10 atypical or suspicious cases that later were confirmed to be malignant, the final diagnosis of malignant disease was not made due to scant cellularity that could be attributed to sampling error in 8 cases and to interpretative disagreement in 2 cases (20%). All four false-negative diagnoses were attributed to sampling error. Two percent of all biopsies were inadequate for interpretation. Of the 99 adequate specimens, 72 yielded true-positive results, 23 yielded true-negative results, and 4 yielded false-negative results. No false-positives were encountered. Therefore, the sensitivity, specificity, positive predictive value, and negative predictive value of EUS-FNAB for solid pancreatic masses were 94.7% (95% confidence interval [CI], 89.7-99.8%), 100%, 100%, and 85.2% (95% CI, 71.8-98.6%), respectively. CONCLUSIONS: EUS-FNAB is a safe and highly accurate method for tissue diagnosis of patients with solid pancreatic lesions. Patients with suspicious and atypical EUS-FNAB aspirates deserve further clinical evaluation.

Adult↗

Prospective evaluation of droperidol on sphincter of Oddi motility.

BACKGROUND: Droperidol increasingly is used as an effective adjunct for conscious sedation during endoscopic procedures. Given the concern for the effects of narcotics and benzodiazepines on sphincter of Oddi motility, and the potential difficulty in sedating patients undergoing sphincter of Oddi manometry, droperidol could be an ideal agent in this setting. METHODS: Over a 43-month period, consecutive patients undergoing sphincter of Oddi manometry were studied prospectively. Sphincter of Oddi manometry was performed under general anesthesia in all but 10 patients. Standard retrograde pull-through techniques were used to examine the biliary and/or pancreatic sphincter, depending on the indication for sphincter of Oddi manometry. After the initial two pull-throughs, 5 mg of droperidol were given intravenously and measurements were repeated 5 minutes later. RESULTS: A total of 55 patients were studied (42 women [76%], 13 men; mean age 43 years). The basal biliary sphincter pressures measured in 35 patients before and after droperidol were, respectively, 56 mm Hg and 48 mm Hg (p = 0.02); the basal pancreatic sphincter pressures measured in 22 patients before and after droperidol were, respectively, 92 mm Hg and 67 mm Hg (p = 0.29). By using a definition for sphincter of Oddi dysfunction of a basal pressure greater than 40 mm Hg, droperidol would have resulted in a change in diagnosis in 5 patients undergoing biliary manometry (one misclassified as sphincter of Oddi dysfunction, 4 misclassified as normal), and 6 patients undergoing pancreatic sphincter manometry (5 misclassified as sphincter of Oddi dysfunction, one misclassified as normal) (total 19% of procedures). No complication was associated with droperidol use. CONCLUSIONS: Droperidol alters basal sphincter pressures, which in some patients was clinically significant and would have resulted in misclassification. Although safe and well tolerated, droperidol appears to have subtle but clinically significant effects on the sphincter of Oddi.

Adjuvants, Anesthesia↗

Endoscopic stent therapy in advanced chronic pancreatitis: relationships between ductal changes, clinical response, and stent patency.

OBJECTIVE: Pancreatic duct stenting is now recognized as a treatment option for a number of pancreatic disorders. Although stent-induced ductal changes may result, there is little information regarding the frequency of these stent-induced changes in chronic pancreatitis and their relationship to stent occlusion and clinical response. Our objectives were to evaluate pancreatic ductal changes after endoscopic stenting in patients with preexisting radiographic evidence of chronic pancreatitis and to evaluate the relationships between ductal changes, pain response, and stent patency. METHODS: Twenty-five consecutive patients had 40 stent placement episodes. Main pancreatic duct diameter, pancreatitis grade, preexisting obstructive lesions, and stent-induced strictures were recorded. Pain response and stent patency were correlated with main pancreatic duct caliber change using chi(2) analysis. RESULTS: In 28 (70%) of 40 episodes, main pancreatic duct caliber increased or was unchanged after stenting; pain improved in 20 (71%) of 28. Pain improved in six (50%) of 12 patients with smaller ducts after stenting. Stent patency was documented upon retrieval in 34 episodes; most stents were occluded. Stent-induced strictures developed in 18% of 40 stent episodes. CONCLUSIONS: Main pancreatic duct caliber after endoscopic stenting was not a good indicator of pain response or stent patency; main pancreatic duct was often larger, and even with stent occlusion, patients' symptoms were frequently improved. Stent-induced strictures were infrequent, compared with values previously reported in the literature.

Abdominal Pain↗

Incomplete response to endoscopic sphincterotomy in patients with sphincter of Oddi dysfunction: evidence for a chronic pain disorder.

OBJECTIVES: The efficacy of endoscopic treatment of sphincter of Oddi dysfunction (SOD) with endoscopic sphincterotomy (ES) remains controversial. Although some studies have shown a positive impact on patient symptoms after treatment, these reports have been largely qualitative and evaluated on short-term response. The aim of our study was to quantitatively measure the long-term outcomes of endoscopic therapy in patients with SOD. METHODS: Thirty-three patients with suspected SOD underwent selective sphincter of Oddi manometry (SOM) of the biliary and/or pancreatic sphincter. Each patient completed a telephone-based survey measuring symptomatic pain before and after SOM +/- ES. The questioner was blinded to the results of SOM. The patients with normal SOM or SOD but who did not undergo ES served as controls. RESULTS: Of these 33 patients (27 women, mean age 48.7 yr, range 13-74), 19 (57.5%) were found to have SOD (12 biliary, six pancreatic, one both). The average follow-up was 18.1 months (range 7-34). Of the patients with SOD, 17 (89%) underwent ES. At follow-up of the 19 patients undergoing ES, five were taking narcotics for persistent pain, two were taking antidepressants, and 15 identified the endoscopic therapy as the reason for their relief. Of the 14 controls, seven were taking narcotics, seven were taking antidepressants, and two identified the endoscopy as the reason for their relief; some patients were taking both antidepressants and narcotics. CONCLUSIONS: Patients found to have SOD who undergo ES are more likely to be improved on long-term follow-up when compared with patients with suspected SOD but normal manometry without ES. However, almost uniformly, despite ES, patients continue to have pain, which is consistent with most chronic pain disorders and which suggests a multifactorial cause for the pain.

Adolescent↗

Endoscopic ultrasound-guided fine needle aspiration biopsy of patients with suspected pancreatic cancer: diagnostic accuracy and acute and 30-day complications.

OBJECTIVES: The aims of this study were to evaluate the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) in patients with suspected pancreatic cancer, and to assess immediate, acute, and 30-day complications related to EUS-FNA. METHODS: All patients with suspected pancreatic cancer were prospectively evaluated. A single gastroenterologist performed all EUS-FNAs in the presence of a cytopathologist. Immediate complications were evaluated in all patients. An experienced nurse called patients 24-72 h and 30 days after the procedure. Reference standard for the classification of the final diagnosis included: surgery (n = 48), clinical or imaging follow-up (n = 63), or death from the disease (n = 47). RESULTS: A total of 158 patients (mean age 62.3 yr) underwent EUS-FNA during the study period. The mean tumor size was 32 x 26 mm. The median number of passes was three (range one to 10). Of these patients, 44% had at least one failed attempt at tissue diagnosis before EUS-FNA. The sensitivity, specificity, PPV, NPV, and accuracy of EUS-FNA in solid pancreatic masses were 84.3%, 97%, 99%, 64%, and 84%, respectively. Immediate self-limited complications occurred in 10 of the 158 EUS-FNAs (6.3%). Of 90 patients contacted at 24-72 h, 78 patients (87%) responded. Of the 90 patients, 20 (22%) reported at least one symptom, all of which were minor except in three cases (one self-limited acute pancreatitis and two emergency room visits, one of which led to admission). In all, 83 patients were contacted at 30 days, and 82% responded. No additional or continued complications were reported. CONCLUSIONS: EUS-FNA is highly accurate in identifying patients with suspected pancreatic cancer, especially when other modalities have failed. Major complications after EUS-FNA are rare, and minor complications are similar to those reported for upper endoscopy. It seems that follow-up at 1 wk might capture all of the adverse events related to EUS-FNA.

Biopsy, Needle↗

Prognostic factors for the survival of patients with esophageal carcinoma in the U.S.: the importance of tumor length and lymph node status.

BACKGROUND: The current TNM classification system does not consider tumor length or the number of lymph nodes in the staging and classification scheme for patients with esophageal carcinoma. Using data from the National Cancer Institute SEER Program, the authors explored the effect of tumor length and number of positive lymph nodes on survival in patients with esophageal carcinoma. METHODS: Patients with esophageal adenocarcinoma or squamous cell carcinoma were subgrouped according to historic stage with localized, regional, or distant disease. Demographic factors (age at diagnosis, race, and gender) and tumor characteristics (morphology, histologic grade, tumor length, primary site, depth of invasion, number of positive lymph nodes, proportion of positive lymph nodes dissected, and distant metastatic sites) were examined. RESULTS: Overall factors that were associated with an increased mortality risk included increasing age at diagnosis, black race versus white race, histologic grade, primary tumor site in the lower esophagus and abdomen versus upper regions, and increasing depth of invasion. Among patients with regional disease, the number of positive lymph nodes (>/= 5 vs. < 5) was related to an increasing risk (hazard ratio [HR], 1.29; 95% confidence interval [95%CI], 1.06-1.56). The proportion of positive lymph nodes compared with the number of lymph nodes dissected conferred an increased risk (HR, 1.63; 95%CI, 1.26-2.11). Among patients with distant disease, sites other than distant lymph nodes implied an increased mortality risk (HR, 1.37; 95%CI, 1.37-1.65). Tumor length was an independent predictor of mortality when controlling for depth of invasion in patients with localized disease (HR, 1.15; 95%CI, 1.08-1.21). CONCLUSIONS: Tumor length, the number of involved lymph nodes, and the ratio of positive lymph nodes are important prognostic factors for survival in patients with esophageal carcinoma. A revised TNM classification system for patients with esophageal carcinoma might consider adding tumor length and number of positive lymph nodes as two important prognostic factors.

Adenocarcinoma↗

Endoscopic ultrasound-guided fine-needle aspiration biopsy: a study of 103 cases.

BACKGROUND: Endoscopic ultrasound (EUS) provides detailed imaging of both intramural and extramural structures within the abdomen and mediastinum. However, EUS is limited in its ability to differentiate an inflammatory/reactive process from a malignancy. Fine-needle aspiration biopsy (FNAB), coupled with EUS, allows for the sampling of the target lesion under ultrasound guidance in real time. To better evaluate the clinical utility and efficiency of EUS-FNAB, a retrospective analysis of the first 103 EUS-FNABs performed at our institute was undertaken. METHODS: EUS-FNABs was performed in 80 patients with 103 lesions. Both air-dried and alcohol-fixed smears were prepared and stained with Diff-Quik (American Scientific Products, McGraw Park, IL) and Papanicolaou stains, respectively. In addition, ThinPrep slides (Cytyc, Boxborough, MA) and cell blocks, when additional material was available, were also prepared. Immunohistochemical stains were performed on cell blocks wherever required. Cytologic diagnoses were then correlated with the final diagnoses. The latter was based on histologic examination of biopsies/resected pathology materials (n = 54) and clinical follow up (n = 48). Follow-up information was not available for one lesion. RESULTS: Of 103 EUS-FNABs, 42 FNABs were from the pancreas, 38 from the lymph nodes (10 mediastinal and 28 intraabdominal), 10 from the gastrointestinal tract, 7 from the liver, 4 from the adrenal gland, 1 from the biliary tract, and 1 from a retroperitoneal mass. The mean number of passes to obtain diagnostic materials was 3.3. Of 103 EUS-FNABs, 45, 9, 6, and 37 were reported as malignant, suspicious, atypical, and benign, respectively. Six FNABs were nondiagnostic. The authors did not encounter any false-positive cases. There were three false-negative cases (two pancreatic carcinomas and one gastrointestinal stromal tumor of the stomach). No complications were encountered. The sensitivity, specificity, and accuracy were 71%, 100%, and 81%, respectively. If the FNABs that were classified as suspicious were considered as malignant, the sensitivity, specificity, and accuracy were 86%, 100%, and 91%, respectively. CONCLUSIONS: EUS-FNAB is a safe and accurate diagnostic procedure for the evaluation of intramural and extramural lesions of the gastrointestinal tract. In the majority of cases, it obviates the need for more invasive diagnostic procedures to obtain a tissue diagnosis.

Adult↗