Can endoscopic ultrasound or magnetic resonance cholangiopancreatography replace ERCP in patients with suspected biliary disease? A prospective trial and cost analysis.

OBJECTIVES: ERCP is the gold standard for pancreaticobiliary evaluation but is associated with complications. Less invasive diagnostic alternatives with similar capabilities may be cost-effective, particularly in situations involving low prevalence of disease. The aim of this study was to compare the performance of endoscopic ultrasound (EUS) with magnetic resonance cholangiopancreatography (MRCP) and ERCP in the same patients with suspected extrahepatic biliary disease. The economic outcomes of EUS-, MRCP-, and ERCP-based diagnostic strategies were evaluated. METHODS: Prospective cohort study of patients referred for ERCP with suspected biliary disease. MRCP and EUS were performed within 24 h before ERCP. The investigators were blinded to the results of the alternative imaging studies. A cost-utility analysis was performed for initial ERCP, MRCP, and EUS strategies for these patients. RESULTS: A total of 30 patients were studied. ERCP cholangiogram failed in one patient, and another patient did not complete MRCP because of claustrophobia. The final diagnoses (N = 28) were CBD stone (mean = 4 mm; range = 3-6 mm) in five patients; biliary stricture in three patients, and normal biliary tree in 20. Two patients had pancreatitis after therapeutic ERCP, one after precut sphincterotomy followed by a normal cholangiogram. EUS was more sensitive than MRCP in the detection of choledocolithiasis (80% vs 40%), with similar specificity. MRCP had a poor specificity and positive predictive value for the diagnosis of biliary stricture (76%/25%) compared to EUS (100%/100%), with similar sensitivity. The overall accuracy of MRCP for any abnormality was 61% (95% CI = 0.41-0.78) compared to 89% (CI = 0.72-0.98) for EUS. Among those patients with a normal biliary tree, the proportion correctly identified with each test was 95% for EUS and 65% for MRCP (p < 0.02). The cost for each strategy per patient evaluated was $1346 for ERCP, $1111 for EUS, and $1145 for MRCP. CONCLUSIONS: In this patient population with a low disease prevalence, EUS was superior to MRCP for choledocholithiasis. EUS was most useful for confirming a normal biliary tree and should be considered a low-risk alternative to ERCP. Although MRCP had the lowest procedural reimbursement, the initial EUS strategy had the greatest cost-utility by avoiding unnecessary ERCP examinations.

Radiofrequency energy delivery to the gastroesophageal junction for the treatment of GERD.

BACKGROUND: In this multi-center study, the feasibility, safety, and efficacy of radiofrequency (RF) energy delivery to the gastroesophageal junction (GEJ) for the treatment of gastroesophageal reflux disease (GERD) were investigated. METHODS: Forty-seven patients with classic symptoms of GERD (heartburn and/or regurgitation), a daily anti-secretory medication requirement, and at least partial symptom response to drugs were enrolled. All patients had pathologic esophageal acid exposure by 24-hour pH study, a 2 cm or smaller hiatal hernia, grade 2 or less esophagitis, and no significant dysmotility or dysphagia. RF energy was delivered with a catheter and thermocouple-controlled generator to create submucosal thermal lesions in the muscle of the GEJ. GERD symptoms and quality of life were assessed at 0, 1, 4, and 6 months with the short-form health survey (SF-36). Anti-secretory medications were withdrawn 7 days before each assessment of symptoms and pH/motility study. Medication use, endoscopic findings, esophageal acid exposure, and motility were assessed at 0 and 6 months. RESULTS: Thirty-two men and 15 women underwent treatment. At 6 months there were improvements in the median heartburn score (4 to 1, p < or = 0.0001), GERD score (26 to 7, p < or = 0.0001), satisfaction (1 to 4, p < or = 0.0001), mental SF-36 (46.2 to 55.5, p = 0.01), physical SF-36 (41.1 to 51.9, p < or = 0.0001), and esophageal acid exposure (11.7% to 4.8%, p < or = 0.0001). Esophagitis was present in 25 patients before treatment (15 grade 1 and 10 grade 2) and 8 had esophagitis at 6 months (4 grade 1 and 4 grade 2, p = 0.005). At 6 months, 87% no longer required proton pump inhibitor medication. There was no significant change in median lower esophageal sphincter pressure (14.0 to 12.0 mm Hg, p = 0.19), peristaltic amplitude (64 to 66 mm Hg, p = 0.71), or lower esophageal sphincter length (3.0 to 3.0, p = 0.28). There were 3 self-limited complications (fever for 24 hours, odynophagia lasting for 5 days, and a linear mucosal injury that was healed after 3 weeks). CONCLUSION: RF energy delivery significantly improved GERD symptoms, quality of life, and esophageal acid exposure while eliminating the need for anti-secretory medication in the majority of patients with a heterogeneous spectrum of clinical disease severity but with minimal active esophagitis or hiatal hernia.

The accuracy of EUS and helical CT in the assessment of vascular invasion by peripapillary malignancy.

BACKGROUND: The relative accuracy of helical CT and EUS for defining the local resectability of peripapillary malignancies is undefined. METHODS: Fifty-one patients with a peripapillary malignancy and no metastatic disease were prospectively evaluated with helical CT and EUS. Imaging results were compared with surgical staging, and a tumor was defined as resectable when there was no macroscopic or microscopic residual tumor. RESULTS: Nine patients had surgically confirmed locally unresectable disease, which was accurately predicted by EUS in 6 patients (sensitivity 67%) and by helical CT in 3 patients (sensitivity 33%; p = 0.35). When only patients with complete EUS examinations were included, the sensitivities of EUS and helical CT for vascular invasion were 100% and 33% (p = 0.06), respectively. When all patients not undergoing surgery because of imaging evidence of locally unresectable disease were included, the sensitivities were 100% and 62.5% (p = 0.02), respectively. One of 15 patients with a tumor amenable to surgical resection was labeled as unresectable by EUS but subsequently had a local recurrence of the tumor. The specificities of EUS (93%) and helical CT (100%) were similar. CONCLUSION: EUS is more sensitive than helical CT for detecting vascular invasion by peripapillary malignancies and should be added to staging protocols, particularly when findings on helical CT are equivocal.

Endoscopic ultrasound is highly accurate and directs management in patients with neuroendocrine tumors of the pancreas.

UNLABELLED: Preoperative localization of pancreatic neuroendocrine tumors with traditional imaging fails in 40-60% of patients. Endoscopic ultrasound (EUS) is highly sensitive in the detection of these tumors. Previous reports included relatively few patients or required the collaboration of multiple centers. We report the results of EUS evaluation of 82 patients with pancreatic neuroendocrine tumors. METHODS: We prospectively used EUS early in the diagnostic evaluation of patients with biochemical or clinical evidence of neuroendocrine tumors. Patients had surgical confirmation of tumor localization or clinical follow-up of >1 yr. RESULTS: Eighty-two patients underwent 91 examinations (cases). Thirty patients had multiple endocrine neoplasia syndrome type 1. One hundred pancreatic tumors were visualized by EUS in 54 different patients. The remaining 28 patients had no pancreatic tumor or an extrapancreatic tumor. Surgical/pathological confirmation was obtained in 75 patients. The mean tumor diameter was 1.51 cm and 71% of the tumors were < or =2.0 cm in diameter. Of the 54 explorations with surgical confirmation of a pancreatic tumor, EUS correctly localized the tumor in 50 patients (93%). Twenty-nine insulinomas, 18 gastrinomas, as well as one glucagonoma, one carcinoid tumor, and one somatostatinoma were localized. The most common site for tumor localization was the pancreatic head (46 patients). Most tumors were hypoechoic, homogenous, and had distinct margins. EUS of the pancreas was correctly negative in 20 of 21 patients (specificity, 95%). EUS was more accurate than angiography with or without stimulation testing (secretin for gastrinoma, calcium for insulinoma), transcutaneous ultrasound, and CT in those patients undergoing further imaging procedures. EUS was not reliable in localizing extrapancreatic tumors. CONCLUSIONS: In this series, the largest single center experience reported to date, EUS had an overall sensitivity and accuracy of 93% for pancreatic neuroendocrine tumors. Our results support the use of EUS as a primary diagnostic modality in the evaluation and management of patients with neuroendocrine tumors of the pancreas.

Diagnosis and management of supra-esophageal complications of reflux disease.

Supra-esophageal reflux disease may be manifested in numerous ways, including reflux laryngitis, chronic cough, chronic sinusitis, and dental enamel loss. The mechanisms of pharyngeal and laryngeal reflux are not clearly defined, and standard reflux testing does not consistently demonstrate supra-esophageal reflux. The diagnosis is usually based on clinical suspicion when other causes of symptoms are not found and on the patient's response to empiric acid suppression. With the development of triple-probe pH monitoring, through which pharyngeal pH can be assessed along with esophageal pH, the physician may now be able to demonstrate pharyngeal reflux in relation to patient symptoms. Therapy consists primarily of behavioral modification and aggressive acid suppression, although some alternative therapies exist.

Gastroesophageal reflux and laryngitis: a skeptic's view.

Gastroesophageal reflux disease (GERD) and laryngitis are common problems in the community. To prove a causal relationship between GERD and laryngitis, one must show the mechanism for acid-induced laryngitis, establish the frequency of association, have a gold standard for diagnosis of the condition, and show that treatment that reduces acid reduces laryngitis in double-blind, randomized, placebo-controlled trials. This article examines each of these components and finds that all are wanting as proof for reflux-induced laryngitis. The best approach to prove the association between GERD and laryngitis will likely lie in well-designed treatment trials.

EUS compared with CT, magnetic resonance imaging, and angiography and the influence of biliary stenting on staging accuracy of ampullary neoplasms.

BACKGROUND: Computerized tomography (CT), magnetic resonance imaging (MRI), and transabdominal ultrasound frequently fail to detect ampullary lesions. Endoscopic ultrasound (EUS) is a sensitive modality for detecting and staging ampullary tumors. Accurate staging may be affected by biliary stenting, which is frequently performed in these patients with obstructive jaundice. The present study assessed the accuracy of ampullary tumor staging with multiple imaging modalities in patients with and those without endobiliary stents. METHODS: Fifty consecutive patients with ampullary neoplasms from two endosonography centers were preoperatively staged by EUS plus CT (37 patients), MRI (13 patients), or angiography (10 patients) over a 3(1/2) year period. Twenty-five of the 50 patients had a transpapillary endobiliary stent present at the time of endosonographic examination. Accuracy of EUS, CT, MRI, and angiography was assessed with the TNM classification system and compared with surgical-pathologic staging. The influence of an endobiliary stent present at the time of EUS on staging accuracy of EUS was also evaluated. RESULTS: EUS was more accurate than CT and MRI in the overall assessment of the T stage of ampullary neoplasms (EUS 78%, CT 24%, MRI 46%). No significant difference in N stage accuracy was noted between the three imaging modalities (EUS 68%, CT 59%, MRI 77%). EUS T stage accuracy was reduced from 84% to 72% in the presence of a transpapillary endobiliary stent. This was most prominent in the understaging of T2/T3 carcinomas. CONCLUSIONS: EUS is superior to CT and MRI in assessing T stage but not N stage of ampullary lesions. The presence of an endobiliary stent at EUS may result in underestimating the need for a Whipple resection because of tumor understaging.

Utility of a linear array ultrasound endoscope in the evaluation of suspected pancreatic disease.

Endoscopic ultrasonography (EUS) is currently being used to evaluate and stage pancreaticobiliary malignancies and neuroendocrine tumors, and to perform aspiration for cytologic diagnosis. There are currently two different commercially available EUS systems for clinical use. One system uses a mechanical radial sector scanner oriented in a plane perpendicular to the long axis of the endoscope, and the other uses an electronic convex scanner that is oriented in the long axis of the endoscope. The vast majority of the current literature reports experience using the radial scanning device in the evaluation of pancreaticobiliary abnormalities. We prospectively evaluated the linear probe as the sole instrument for EUS in 26 patients with suspected pancreatic disease. The results of the endoscopic ultrasound examination were compared with the results of surgery or long-term clinical follow-up. The sensitivity and specificity of linear array EUS for benign pancreatic disease were 93.8% and 88.2%, respectively. The sensitivity and specificity for malignant disease of the pancreas were 80.0% and 88.9%, respectively. The linear array echoendoscope, employed as the only instrument for evaluation of the pancreas, is accurate in the evaluation of pancreatic disease. The addition of EUS-guided pancreatic biopsy would be anticipated to improve the sensitivity of the linear array instrument for detecting malignancy.

Screening for colorectal cancer.

Randomized, controlled trials have shown with certainty that screening for colorectal cancer reduces morbidity and is cost-effective. Factors that increase the risk of colorectal cancer include a personal or family history of adenomatous polyps or colorectal cancer, certain genetic syndromes and chronic inflammatory bowel disease.

Esophageal dilation.

Esophageal dilation, a technique developed four centuries ago, continues to be an important method of treating the symptom of dysphagia in patients with luminal narrowing of the esophagus. Dilation is safe, with < 0.5% chance of perforation and bleeding and a 0.01% risk of death. Mercury bougienage (Maloney dilators), hollow polyvinyl dilators (Savary-Guillard), and balloon dilators (Through the Scope) are the principal types of dilators in use today. Few trials have compared the differing dilating methods. The results of these trials are mixed, and further randomized trials are necessary to determine if any technique has advantages in efficacy and cost. Although most patients successfully treated with dilation suffer with peptic strictures, those with nonpeptic strictures due to lower esophageal mucosal rings, corrosive injury, and radiation injury can also be treated effectively with dilation. By reviewing the current literature, effective treatment algorithms can be used with patients suffering from dysphagia due to various types of strictures.

Pathophysiology and endoscopic/balloon treatment of esophageal motility disorders.

Diagnostic and therapeutic dilemmas associated with esophageal dysmotility syndromes continue to confront physicians managing these patient populations. Although modern manometric systems have allowed us to better define normal parameters of esophageal motility, with the exception of primary achalasia, the clinical relevance of many aberrant motor patterns remains unclear. The novel use of botulinum toxin in idiopathic achalasia stems from increased understanding of the pathogenesis of the disease. Similarly, as our knowledge of the pathophysiology of other esophageal motor disorders grows, in conjunction with improved diagnostic capabilities, more effective management strategies may be used in the future.

Lansoprazole and ranitidine affect the accuracy of the 14C-urea breath test by a pH-dependent mechanism.

OBJECTIVES: To determine the effect of lansoprazole and high dose ranitidine on the accuracy of the 14C-urea breath test (UBT). Using intragastric pH recordings, we correlated the effect of these agents on the UBT with their potency of gastric acid suppression. METHODS: Patients with active Helicobacter pylori infection underwent a baseline UBT before receiving 14 days of lansoprazole (30 mg/day) or ranitidine (300 mg b.i.d.). During therapy, patients were asked to undergo 24-h intragastric pH monitoring. Repeat breath testing was performed 1 day after completion of the study drugs. If the UBT was equivocal or negative (14CO2 excretion was < 200 dpm), further UBTs were completed until the 14CO2 excretion was > 200 dpm. RESULTS: Thirteen patients received lansoprazole. Eight of thirteen patients developed a negative or equivocal UBT. All patients had 14CO2 excretion > 200 dpm 5 days after the cessation of lansoprazole. Eleven patients received ranitidine. Ranitidine led to equivocal or false negative UBTs in 2 of 11 cases. This effect resolved within 5 days of stopping ranitidine. Intragastric pH recordings revealed that the patients who experienced the most profound gastric acid suppression were those that developed equivocal or false negative UBTs. CONCLUSIONS: Lansoprazole significantly affected the accuracy of the UBT, causing equivocal or false negative results in 61%. High dose ranitidine affected the breath test in only 18%. The ability of these drugs to suppress gastric acid secretion predicted those patients who developed equivocal or false-negative UBTs. The effect on the accuracy of the UBT resolved within 5 days of drug cessation.

Gadolinium-enhanced MR angiography of visceral arteries in patients with suspected chronic mesenteric ischemia.

The purpose of this study was to evaluate accuracy of dynamic gadolinium-enhanced MR angiography (MRA) of the celiac, superior, and inferior mesenteric arteries in patients with suspected mesenteric ischemia compared with catheter angiography or surgery. Sixty-five patients with suspected mesenteric ischemia underwent three-dimensional spoiled gradient-recalled acquisition in the steady state (GRASS) gadolinium-enhanced MRA. Correlative studies were performed on 14 patients, catheter angiography alone was performed on 12 patients, and surgery alone was performed on two patients. Six patients had mesenteric ischemia. In all patients, the celiac artery (CA) and superior mesenteric artery (SMA) were seen well enough to evaluate; however, the inferior mesenteric artery (IMA) could be evaluated in only 9 of the 14 patients. MRA showed severe stenosis (> 75%) or occlusion of the celiac axis in seven patients, of the SMA in six patients, and of the IMA in four patients. The overall sensitivity and specificity were 100% and 95%, respectively, compared with catheter angiography and surgery. The two errors were caused by overgrading the severity of IMA disease. Three-dimensional gadolinium-enhanced MRA can accurately demonstrate the origins of the CA and SMA and is useful in evaluation of patients with suspected mesenteric ischemia.

Esophageal dysphagia as the sole symptom in type I Chiari malformation.

Chiari malformation, also called Arnold-Chiari deformities, are rare hindbrain herniations that may present in children or adults. The most common symptoms include headache, syncope, disordered eye movement, sensory loss, weakness, and cerebellar features such as ataxia. Dysphagia occurs in 5-15% of patients, although only a few reports describe dysphagia as the only presenting symptom. We report a case of a 27-year-old woman who presented with a three-year history of dysphagia, chest pain, and weight loss. Esophageal manometrics revealed markedly disordered esophageal motility and gastroesophageal reflux. Her symptoms failed to respond to high doses of omeprazole, prokinetics, and eventually surgical fundoplication. The subsequent onset of neurological symptoms led to the diagnosis of Chiari type I malformation. Following posterior craniotomy with decompression, her dysphagia and chest discomfort completely resolved. Repeat esophageal manometrics revealed complete resolution of prior abnormalities.

Hemorrhagic complications of large volume abdominal paracentesis.

The incidence of hemorrhagic complications from large volume paracentesis in patients with cirrhosis and portal hypertension is unknown. We have reviewed the cases of 179 outpatients undergoing large volume paracentesis at our institution during a 1-yr period. Of these 179 patients, four developed severe hemorrhagic complications requiring hospital admission and blood transfusion. Three of these patients developed intraperitoneal hemorrhage, one of which was localized to the paracentesis puncture site. One patient experienced an abdominal wall hematoma, localized by ultrasound. The symptoms and signs of hemorrhage became evident anywhere from hours up to 1 wk after completion of the paracentesis procedure. The mechanism of delayed hemorrhage is not known but may relate to the the rupture of large intra-abdominal venous collaterals in these patients. The literature does not support a correlation between degree of coagulopathy or thrombocytopenia and risk of bleeding in this setting. To promote early detection of this potentially life-threatening complications, a mechanism should exist for close outpatient follow-up of patients after large volume paracentesis.

Prolonged effect of omeprazole on the 14C-urea breath test.

OBJECTIVES: We investigated omeprazole's effect on 14C-urea breath testing. We also determined the duration of omeprazole's effect on the breath test. Finally, we studied whether effects on breath testing were dose dependent. METHODS: Fifty-seven employees and outpatients were screened for Helicobactor infection. Those positive for serology, CLO, or histology were asked to undergo baseline breath testing. Those with a positive breath test took omeprazole 20 mg/day for 14 days followed by repeat breath testing, 1, 3, and 5 days after therapy. Subjects with persistently positive breath tests despite omeprazole 20 mg/day were asked to take omeprazole 20 mg b.i.d. for 14 days. Repeat breath tests were performed as above. RESULTS: Thirteen of 57 had HP infection. Ten of 13 underwent a baseline breath test. Eight of 10 with baseline breath test experienced a significant decrease in expired 14CO2 after omeprazole 20 mg/day. Five of 13 with active HP infection developed a negative breath test after omeprazole. All subjects had a positive breath test within 5 days of stopping omeprazole 20 mg/day. Five of eight with persistently positive breath tests despite omeprazole 20 mg/day took omeprazole 40 mg/day. Four of five developed a significant decrease in 14CO2 excretion after omeprazole. All subjects had a positive breath test within 5 days of stopping omeprazole 40 mg/day. CONCLUSIONS: Recent treatment with omeprazole 20 mg/day led to a false-negative breath tests in 38.5%. This effect appeared to be dose dependent and lasted up to 5 days after cessation of omeprazole.

Esophageal dilatation.

Esophageal dilatation as a treatment option in patients with both benign and malignant esophageal strictures is described. Types of dilators available, techniques of passage, complications, redilation rates, and comparative studies between dilating systems are reviewed. The use of proton pump inhibitors to reduce the rates of redilation is discussed in view of the natural history of benign esophageal strictures. Comparisons among blind passage, fluoroscopic guidance and endoscopically directed dilatation are made and discussed in relation to cost effectiveness. Brief mention of new dilating systems including wall stents and wall-tension-sensing systems are made. Achalasia treatment with pneumatic dilatation is described in detail and compared to medication and surgical myotomy options. New treatments, including botulinum toxin injection into the lower esophageal sphincter, are briefly mentioned.

Single-day, divided-dose oral sodium phosphate laxative versus intestinal lavage as preparation for colonoscopy: efficacy and patient tolerance.

Polyethylene glycol-electrolyte lavage solutions are widely used to prepare the colon for colonoscopy. Unfortunately, some patients find this preparation difficult to complete. Recent studies of a sodium phosphate-based laxative have shown both good patient tolerance and good bowel preparation. In these studies, the laxative has generally been prescribed in two doses, with the second dose taken early the morning of colonoscopy. Because the morning dose is inconvenient for many patients, we compared giving a common polyethylene glycol-based electrolyte lavage solution the day before colonoscopy with our method of giving both doses of sodium phosphate-based laxative the day before colonoscopy: one dose at 4 PM and the second dose at 8 PM. We judged efficacy by an assessment of residual liquid and fecal matter in the colon and judged tolerance by the results of a symptom questionnaire completed by each patient immediately before the procedure. Our results in more than 200 patients showed similar efficacy ratings and similar symptom scores for both preparations, but patients rated the sodium phosphate-based preparation as easier to tolerate. In conclusion, in selected patients this new dosing method for sodium phosphate is preferable to large-volume, whole-gut lavage solutions.

Long-term follow-up of Helicobacter pylori treatment in non-ulcer dyspepsia patients.

BACKGROUND/AIMS: It remains controversial whether Helicobacter pylori infection causes symptoms in non-ulcer dyspepsia. One hundred non-ulcer dyspepsia patients were screened for H. pylori infection between November 1989 and February 1994. Forty patients entered a trial where both infected and uninfected patients were treated with H. pylori therapy, with the uninfected group serving as controls. METHODS: Non-ulcer dyspepsia was defined as unexplained epigastric discomfort lasting for at least 4 wk. From November 1989 until February 1992, all patients, regardless of H. pylori status, were treated with bismuth subsalicylate tablets (524 mg q.i.d.) for 4 wk and metronidazole (250 mg q.i.d.) for the first 2 of the 4 wk. From March 1992 until February 1994, only infected patients were treated in an attempt to obtain equal numbers in each group. H. pylori infection was diagnosed histologically at the index endoscopy and 1 month after completion of therapy. Symptoms were scored on a 0-5 scale for both frequency and severity. RESULTS: Of 100 patients screened, 33 were infected with H. pylori (mean age, 42; 10 men, 23 women), and 67 were uninfected (mean age, 38; 16 men, 51 women). Thirty-six uninfected patients were not offered treatment during the latter part of the trial. Of the remaining 31 uninfected patients, 10 dropped out; of the 33 infected patients, 14 dropped out. Twenty-one uninfected patients and 19 H. pylori-infected patients completed treatment; in 13 of 19 patients (68%), H. pylori was eradicated. Symptoms improved in eight of 13 (61%) H. pylori-eradicated patients and in four of six (66%) H. pylori-persistent patients, compared with 14 of 21 (66%) uninfected patients. Long-term follow-up (mean, 34 months) showed similar symptom outcome in the two treatment groups. CONCLUSIONS: Thirty-three percent of our non-ulcer dyspepsia patients were infected with H. pylori, a number similar to the percentage of infected age-matched controls in the U.S. Treatment with bismuth subsalicylate and metronidazole resulted in symptomatic improvement in 61-66% of non-ulcer dyspepsia patients regardless of initial or post-treatment H. pylori status. Long-term symptom follow-up in both the control and infected groups gave similar results. H. pylori infection is not related to the symptoms of non-ulcer dyspepsia.