Routine upper GI series after gastric bypass does not reliably identify anastomotic leaks or predict stricture formation.

BACKGROUND: Many surgeons who perform Roux-en-Y gastric bypass (RYGB) for morbid obesity routinely obtain an upper gastrointestinal (GI) series in the early postoperative period to search for anastomotic leaks and signs of stricture formation at the gastrojejunostomy. We hypothesized that this practice is unreliable. METHODS: We analyzed 654 consecutive RYGBs, of which 63% were completed laparoscopically. An upper GI series was obtained in 634 (97%) patients. The radiographic findings (leak or delayed emptying) were compared with clinical outcomes (leak or stricture formation) to calculate the sensitivity and specificity. Univariate analysis identified risk factors for leaks or stricture formation; events were too few for multivariate analysis. RESULTS: Of 634 routine upper GI series, anastomotic leaks at the gastrojejunostomy were diagnosed in 5 (0.8%); 2 of these 5 were later reinterpreted as artifacts. Four leaks were not seen on the initial upper GI series, yielding an overall sensitivity of 43% and a positive predictive value (PPV) of 60%. Univariate analysis showed that cases done early (odds ratio [OR] 5.4 for the first 100 cases, p = 0.02) and prolonged operating time (OR 7.8 for cases >or= 300 min, p = 0.01) were associated with leaks. Emptying into the Roux-en-Y limb was delayed in 127 (20%) of the upper GI series. Strictures requiring dilatation developed in 16 (2.4%) patients. The PPV of delayed emptying for stricture formation was 6%. Risk factors for stricture formation included stapled anastomosis (OR 7.8, p = 0.002), surgeon inexperience (OR 2.9 for first 50 cases, p = 0.04), and delayed emptying (OR 3.3; p = 0.02). CONCLUSIONS: Because the incidence of anastomotic complications and the sensitivity of upper GI series were both low, routine upper GI series did not reliably identify leaks or predict stricture formation. A selective approach, whereby imaging is reserved for patients with clinical evidence of a leak or stricture, may be more appropriate.

Comparison of patients' experiences during imaging tests of the colon.

BACKGROUND: Physical discomfort, anxiety, embarrassment, and other aspects of patient experience impact on future compliance for colonic imaging tests. Therefore, a prospective study was performed comparing patient experiences during air contrast barium enema (ACBE), flexible sigmoidoscopy, and colonoscopy. METHODS: Immediately after each procedure, patients completed a questionnaire assessing pretest anxiety, difficulty with preparation, pain, cramping, bloating, overall discomfort, loss of dignity, willingness to repeat the test, and overall satisfaction. A follow-up questionnaire was administered within 48 hours. Nurses and physicians also completed questionnaires to assess the provider impression of patient experience. RESULTS: Four hundred ten patients (80 ACBE, 202 sigmoidoscopy, 128 colonoscopy) were prospectively enrolled. Sigmoidoscopy caused more pain than ACBE (Odds ratio [OR] 2.64: 95% CI [1.63, 4.27]) or colonoscopy (OR 1.83: 95% CI [1.21, 2.77]). ACBE and colonoscopy did not differ in the degree of pain. Although overall satisfaction appeared to be similar for all tests, patients were less willing to repeat ACBE than sigmoidoscopy (OR 1.85: 95% CI [1.13, 3.02]) or colonoscopy (OR 1.82: 95% CI [1.07, 3.09]). Initial and follow-up pain ratings by patients were highly correlated (Spearman correlation 0.81); however, correlation of pain assessments between staff and patients was poor (Spearman correlation 0.48). CONCLUSIONS: Sigmoidoscopy was more painful than other colonic imaging modalities. Although ACBE and colonoscopy caused similar pain, patients were less willing to repeat ACBE. In aggregate, the data suggest that patients perceive colonoscopy as the most acceptable colonic imaging procedure. Better methods are required to allow staff to adequately assess discomfort experienced by patients during these procedures.

Prospective comparison of catheter-based endoscopic sonography versus standard endoscopic sonography: evaluation of gastrointestinal-wall abnormalities and staging of gastrointestinal malignancies.

PURPOSE: Endoscopic sonography (EUS) is an important imaging modality for evaluating benign and malignant luminal gastrointestinal-tract abnormalities. The objectives of this study were to evaluate the feasibility of catheter-based EUS (C-EUS) during standard upper and lower endoscopy in patients with malignancies and other abnormalities of the gastrointestinal-tract lumen, to assess the image quality obtained with the 12.5-MHz catheter-based ultrasound transducer, and to prospectively compare the interpretations of C-EUS images with those of the standard EUS (S-EUS) images. METHODS: One hundred thirty-seven consecutive patients referred for EUS were evaluated with C-EUS followed by S-EUS. The patients were assigned to 1 of 2 groups: group A, patients with intramural masses or intestinal wall thickening, with biopsies negative for malignancy; and group B, patients with esophageal, gastric, duodenal, or rectal cancer referred for staging. The results of C-EUS and S-EUS were compared for each group. RESULTS: C-EUS was completed in 134 patients: 81 patients with 83 lesions in group A and 53 patients in group B. For group A, C-EUS image interpretation concurred with that of S-EUS in 74 (89%) of 83 lesions. For group B, C-EUS concurred with S-EUS for tumor depth (T) and nodal (N) classifications in 19 cases (36%) and 26 cases (49%), respectively. The depth of invasion was underestimated by C-EUS in all 34 cases in which the T classifications by C-EUS and S-EUS were discordant. In 1 of 6 patients with stenotic cancer that was nontraversable by S-EUS, C-EUS identified lymphadenopathy (incorrectly classified as N0 by S-EUS). CONCLUSIONS: C-EUS was easily performed, and the C-EUS images were comparable to the S-EUS images in assessing mucosal and intramural lesions. The limited depth of penetration of the catheter-based transducer resulted in understaging the extent of tumor invasion and underestimating the nodal spread.

Octreotide for acute esophageal variceal bleeding: a meta-analysis.

BACKGROUND & AIMS: Studies of octreotide have not demonstrated a consistent benefit in efficacy or safety compared with conventional therapies. This study statistically pooled existing trials to evaluate the safety and efficacy of octreotide for esophageal variceal hemorrhage. METHODS: We identified randomized trials of octreotide for variceal hemorrhage from computerized databases, scientific meeting abstracts, and the manufacturer of octreotide. Blinded reviewers abstracted the data, and a meta-analysis was performed. RESULTS: Octreotide improved control of esophageal variceal hemorrhage compared with all alternative therapies combined (relative risk [RR], 0.63; 95% confidence interval [CI], 0.51-0.77); vasopressin/terlipressin (RR, 0.58; 95% CI, 0.42-0.81); or no additional intervention/placebo (among patients that received initial sclerotherapy/banding before randomization) (RR, 0.46; 95% CI, 0.32-0.67). Octreotide had comparable efficacy to immediate sclerotherapy for control of bleeding (RR, 0.94; 95% CI, 0.55-1.62), fewer major complications than vasopressin/terlipessin (RR, 0.31; 95% CI, 0.11-0.87), and a complication profile comparable to no intervention/placebo (RR, 1.06; 95% CI, 0.72-1.55). No specific alternative therapy demonstrated a mortality benefit. CONCLUSIONS: These results favor octreotide over vasopressin/terlipressin in the control of esophageal variceal bleeding and suggest it is a safe and effective adjunctive therapy after variceal obliteration techniques. Trials are needed to determine the optimal dose, route, and duration of octreotide treatment.

The laparoscopic evaluation of ascites.

Laparoscopy is an invaluable technique for the evaluation of ascites in subgroups of patients with ascites. Indications for laparoscopic examination include determination of the causes of ascites when routine tests fail to disclose the source, evaluation for the presence of multiple causes of ascites formation, or histopathologic verification of malignancy within the peritoneal cavity. Several reported series have illustrated the efficacy of laparoscopy for the diagnosis of peritoneal carcinomatosis, tuberculous peritonitis, or unsuspected cirrhosis, securing its role in the management of selected patients with ascites.

Accuracy of endoscopic databases for assessing patient symptoms: comparison with self-reported questionnaires in patients infected with the human immunodeficiency virus.

BACKGROUND: Endoscopic databases are increasingly used for clinical research, but their validity as research instruments has not been assessed. We compared the accuracy of endoscopic indications recorded in an endoscopic database with patient symptom questionnaires. METHODS: All patients infected with the human immunodeficiency virus referred to the outpatient gastroenterology practice were prospectively evaluated using recognized symptom questionnaires. For patients undergoing esophagogastroduodenoscopy, the procedure indications recorded in the endoscopic database and the patient's self-reported symptom scores were compared. RESULTS: Ninety-three patients were evaluated. The symptoms of nausea/vomiting, diarrhea, and anorexia were highly predictive for the presence of these symptoms on the patient questionnaires. The symptoms of dyspepsia/abdominal pain did not predict well the presence of these symptoms on the questionnaire. Patients reported frequent and severe symptoms that were not recorded as indications for the procedures. The overall agreement (kappa statistic) was highly variable, from slight (kappa = 0.07 for anorexia) to moderate (kappa = 0.44 for diarrhea). CONCLUSIONS: Endoscopic indications are variably associated with self-reported symptom scores. These findings raise concerns about using some endoscopic database indications as accurate representations of patients' symptoms. Until performance characteristics of a given database are known, symptom-oriented research should use validated questionnaires whenever possible.

Lack of effect of treatment for Helicobacter pylori on symptoms of nonulcer dyspepsia.

BACKGROUND: Prior studies have yielded conflicting results on whether or not Helicobacter pylori causes nonulcer dyspepsia. PATIENTS AND METHODS: We enrolled 100 consecutive patients with nonulcer dyspepsia into a randomized, double-blind, placebo-controlled trial. Patients with peptic ulcer disease, esophagitis, hepatobiliary disease, irritable bowel disease, or predominantly reflux-related symptoms were excluded by history and upper endoscopy. Helicobacter pylori infection was determined by biopsy and histologic examination. Serum H. pylori IgG antibodies and CagA status were determined by Western blot. Enrolled patients were randomized to a 14-day regimen of omeprazole (20 mg twice daily) and clarithromycin (500 mg three times daily) or placebo. Dyspeptic symptoms were assessed by use of a visual analog scale at baseline and at 1, 3, 6, and 12 months after treatment. Follow-up upper endoscopy with biopsy was performed 4 weeks after treatment. Compliance was measured by tablet counts. RESULTS: At 1 year, the change in dyspeptic symptoms was -24.0 (95% confidence interval, -69.0 to 21.0) in the omeprazole and clarithromycin group and -24.2 in the placebo group (95% confidence interval, -70.0 to 21.6). Furthermore, patients with persistent H. pylori infection demonstrated a greater, but not significant, improvement in symptoms (-40 +/- 144 [mean +/- SD], -65 +/- 142, -45 +/- 138, and -39 +/- 163) than those with successful eradication (-26 +/- 126, -26 +/- 148, -12 +/- 126, and -25 +/- 151) at months 1, 3, 6, and 12, respectively. CONCLUSION: Patients with nonulcer dyspepsia should not routinely be treated for H. pylori, since it is not a cause of this condition in most patients.

Relationship of low-dose aspirin to GI injury and occult bleeding: a pilot study.

BACKGROUND: Low-dose aspirin is commonly used in patients with cardiovascular disease. However, little is known about the effect of aspirin on occult blood loss caused by gastrointestinal injury. Therefore, we studied endoscopic injury and fecal occult blood loss in patients ingesting different quantities of low-dose aspirin. METHODS: Forty healthy volunteers were enrolled in a randomized, double-blind, prospective, pilot endoscopic study. Each volunteer underwent 30 days of treatment with daily aspirin 30 mg, 81 mg, 325 mg, or placebo. Subjects completed fecal occult blood test cards before and at the end of treatment of two types: guaiac impregnated (Hemoccult and Hemoccult SENSA) and immunochemical (HemeSelect and FlexSure OBT). Each volunteer underwent upper endoscopy at baseline and after completing 30 days of study medication. RESULTS: Aspirin did not induce significant injury as determined by endoscopy when compared with placebo. Six of 30 volunteers taking aspirin developed erosions, whereas 1 of 10 subjects on placebo developed a new erosion (p = 0.66). Aspirin (325 mg) was associated with a higher mean symptom score than the lower aspirin dosages and the placebo group (p = 0.12). Only one subject taking aspirin (325 mg) had fecal occult blood on a single HemeSelect card. No subject had a positive fecal occult blood test with Hemoccult II, Hemoccult II SENSA, or FlexSure OBT cards. CONCLUSIONS: Aspirin in dosages commonly used for cardiovascular prophylaxis does not generally cause significant gastric or duodenal mucosal endoscopic lesions. In the absence of frank ulceration, low-dose aspirin does not result in positive fecal occult blood tests. Low-dose aspirin should not interfere with fecal occult blood testing and probably should not be stopped during stool collection.

Evaluation of upper gastrointestinal tract symptoms in patients infected with HIV.

OBJECTIVE: Upper gastrointestinal tract (UGI) symptoms are frequent in patients infected with the human immunodeficiency virus (HIV), but little published information exists about their characteristics or methods of evaluation. We evaluated the prevalence of nonesophageal UGI symptoms in a referral population, the utility of esophagogastroduodenoscopy (EGD) for diagnosis, and clinical predictors of abnormal endoscopic findings in patients infected with HIV. METHODS: All HIV-infected patients referred to.the outpatient gastroenterology clinics were prospectively evaluated using recognized symptom questionnaires. EGD indications, results, and the patients' self-reported symptom scores were compared. HIV-infected patients undergoing EGD were compared with HIV-infected patients not receiving an EGD and with symptomatic non-HIV-infected patients undergoing EGD. RESULTS: A total of 201 patients completed 280 questionnaires. Among 93 patients who underwent endoscopy, severe symptoms occurring at least several times per week included: anorexia (70%), upper abdominal pain (34%), vomiting (32%), or a recent weight loss of approximately 15 lb (31%). Patients undergoing EGD had more frequent/severe symptoms, but did not have differences in overall well-being or mean GI symptom score. The frequency of substantial and treatable endoscopic findings among patients infected with HIV was comparable to that found in the non-HIV-infected control group. There were no independent symptoms predicting substantial or treatable disease on EGD. CONCLUSIONS: We conclude that: 1) upper gastrointestinal symptoms are common in HIV-infected patients referred for GI consultation; 2) symptomatic HIV patients have a high prevalence of both treatable and untreatable upper GI pathologies; 3) and physicians use symptom frequency and severity to select patients for EGD, but these factors correlate poorly with abnormalities on EGD. Given this discrepancy, longitudinal study is needed to determine whether treating endoscopic abnormalities improves UGI symptoms.

A prospective study of endoscopy in HIV-associated diarrhea.

OBJECTIVE: Diarrhea commonly occurs in persons with human immunodeficiency virus (HIV) infection. The optimal use of endoscopic procedures remains poorly studied for patients with HIV-related diarrhea. The purpose of this study is to compare the diagnostic yield of a complete endoscopic work-up including an esophagogastroduodenoscopy and colonoscopy to a more limited approach of biopsies obtainable by flexible sigmoidoscopy. METHODS: A prospective study of 79 patients with HIV-related diarrhea. Upper endoscopy and colonoscopy were performed with tissue biopsies labelled according to location within the colon or small intestine. RESULTS: A new infection was diagnosed in 22 of 79 patients (28%). Biopsy of the left colon yielded an enteric pathogen in 17 of 22 patients (sensitivity: 77%) and in 15 of 15 patients with cytomegalovirus colitis (sensitivity: 100%). Combined left and right colonic biopsies had a sensitivity of 82%. Combined colonic and terminal ileum biopsies missed no pathogens. Duodenal biopsies yielded no additional pathogens beyond those identified by colonoscopy and terminal ileal biopsy. Patients with a new pathogen diagnosed had significantly lower CD4 lymphocyte counts as compared to patients without a new pathogen (p = 0.001). CONCLUSIONS: For patients with CD4 counts < 100/mm3 and unexplained AIDS-related diarrhea, flexible sigmoidoscopy with biopsy is a sufficiently thorough endoscopic evaluation.

Discrepancy between sex- and water-associated risk behaviors for cryptosporidiosis among HIV-infected patients in San Francisco.

OBJECTIVE: Potential transmission of cryptosporidiosis through drinking water supplies has been highly publicized; however, it is unknown whether this reporting has increased patient awareness or reduced other risk behaviors for exposure to this organism, such as high-risk sexual behavior. METHODS: Consecutive patients presenting for initial evaluation to the Gastroenterology AIDS Clinic completed a questionnaire that assessed knowledge about cryptosporidiosis, perceived risk of infectious diarrhea, drinking water sources, and high-risk sexual behavior. RESULTS: Fifty-one patients completed the questionnaire (82% male; 86% homosexual; mean age, 38 years; median CD4 count, 136 x 10(6) cells/L). Most respondents (31 of 44; 70%) believed they were at risk for infectious diarrhea. Awareness of cryptosporidiosis was high (31 of 45; 69%) as was avoidance of tap water (26 of 51; 51%) and exclusive or frequent use of bottled or boiled water (40 of 51; 78%). Respondents who used bottled water reported spending an average of $331.76 U.S. annually. However, high-risk sexual behavior remained common: 21 (41%) of the 51 subjects reported unprotected anal intercourse or oral-anal sexual contact. High-risk sexual behavior was prevalent even among subjects who drank exclusively boiled or bottled water. CONCLUSIONS: Awareness of risk for infectious diarrhea and cryptosporidiosis is high among patients infected with HIV in San Francisco. Patients perceive drinking water to be a substantial risk factor for infectious diarrhea and incur significant expense to avoid tap water. However, high-risk sexual behaviors remain prevalent in this population and should be the focus of future education efforts.

AIDS-Related biliary tract disease.

Increasingly, specialists caring for patients with AIDS have reported relatively small numbers of patients with biliary tract disease. These conditions fall into three general categories: (1) non-HIV-associated conditions of the bile duct, (2) acalculous cholecystitis, and (3) AIDS cholangiopathy. Whatever the cause, a sizable percentage of patients with AIDS are found to have abnormal biliary tract morphology. It is essential for the clinician first to exclude biliary tract conditions such as gallstone disease and then to clearly investigate those patients with clinical, biochemical, or radiographic features suggestive of papillary stenosis. Patients with AIDS-associated papillary stenosis do respond symptomatically to ERCP sphincterotomy.

De novo lipogenesis predicts short-term body-composition response by bioelectrical impedance analysis to oral nutritional supplements in HIV-associated wasting.

We studied the effects of enteral supplements on protein and energy intakes, body composition, energy expenditure, and gastrointestinal histology in 49 subjects with human immunodeficiency virus-associated weight loss (12.7 +/- 0.9% of body wt). We also determined whether a stable-isotope mass spectrometric measurement at baseline might predict the short-term response of fat-free mass (FFM) measured by bioelectrical impedance analysis. Thirty-nine subjects completed the study after being randomly assigned to receive either a whole-protein-based (n = 22) or a peptide-based (n = 17) formula. A nonsupplemented, nonrandomly assigned group (n = 13) was followed concurrently. Both formulas were well tolerated. Voluntary intakes of energy and protein from nonsupplement sources decreased significantly during supplementation [by 819-1638 kJ (196-382 kcal)/d and 5.6-14.4 g protein/d, respectively; P < 0.01] but to a lesser extent than the intake from the supplement [2300-2510 kJ(550-600 kcal)/d and 19-28 g protein/d, respectively], so that net increases in intakes of protein and energy (P < 0.03), as well as of several vitamins and trace elements were increased. Nevertheless, the mean FFM did not increase for the group as a whole, although there was considerable interindividual heterogeneity. Changes in FFM at 6 wk were significantly inversely correlated (r = 0.65, P < 0.01) with baseline synthesis of fat (de novo hepatic lipogenesis), but not with other potential measures of energy intake (insulin-like growth factor 1 or its binding protein) or inflammation (soluble tumor necrosis factor receptors I or II). The prospective identification of FFM response by measurement of de novo hepatic lipogenesis supported the hypothesis that the subset of wasting patients whose FFM is unresponsive to nutrient supplementation have altered nutrient metabolism.

Relative frequency of upper gastrointestinal and colonic lesions in patients with positive fecal occult-blood tests.

BACKGROUND: Although bleeding lesions anywhere in the gastrointestinal tract can cause a positive reaction on guaiac-based fecal occult-blood tests, the relative frequency of upper gastrointestinal and colonic lesions is unknown. METHODS: During a period of 30 months, we prospectively studied all patients with at least one stool specimen containing fecal occult blood who were referred for further evaluation. Fecal occult blood was detected by standard guaiac-based tests of stool specimens obtained as part of routine screening or of stool obtained by digital rectal examination. Patients with documented iron-deficiency anemia or active gastrointestinal bleeding were excluded from the study. All participants had a detailed history taken and underwent colonoscopy, followed by esophagogastroduodenoscopy. RESULTS: Of the 409 patients with fecal occult blood who were referred, 310 were potentially eligible to participate, and 248 (mean age, 61 years; range, 40 to 89) were studied; 40 percent were women. We identified lesions consistent with occult bleeding in 119 patients (48 percent); in 71 bleeding lesions were found in the upper gastrointestinal tract, and in 54 they were identified in the colon. Six patients had abnormalities in both areas. The most common upper gastrointestinal lesions were esophagitis (23 patients), gastric ulcer (14), gastritis (12), and duodenal ulcer (10). Thirty patients with lesions in the upper gastrointestinal tract were long-term users of aspirin, ethanol, nonsteroidal antiinflammatory drugs, or a combination of these substances. The most common colonic lesions were adenomas more than 1.0 cm in diameter (29 patients), carcinoma (13), colitis (5), and vascular ectasia (5). Although the overall sensitivity of symptoms for the detection of gastrointestinal lesions was low, logistic-regression analysis demonstrated that the presence of symptoms in the upper gastrointestinal tract was associated with the detection of lesions in the upper gastrointestinal tract (odds ratio, 2.6; 95 percent confidence interval, 1.4 to 4.7). In both patients with symptoms and those without symptoms, the prevalence of lesions in the upper gastrointestinal tract was greater than or equal to that of colonic lesions. CONCLUSIONS: In a group of patients with positive fecal occult-blood tests who were referred for further evaluation, from which those with iron-deficiency anemia and active bleeding had been excluded, upper gastrointestinal lesions were identified more frequently than colonic lesions.

The outpatient evaluation of hematochezia.

OBJECTIVE: The objective of this study was to determine whether specific clinical symptoms associated with hematochezia are predictive of important GI pathology and whether full colonoscopic examination is necessary. METHODS: A total of 103 outpatients (> or = 45 yr) with hematochezia, defined as the passage of bright red blood per rectum, underwent anoscopy and colonoscopy. Before endoscopy, patients completed a detailed interview, quantitating the amount and frequency of bleeding, weight loss, use of aspirin/NSAIDs, change in bowel habits, family history, and prior GI illnesses. Based on this information, physicians were asked to predict whether the bleeding was from a perianal or more proximal site. At colonoscopy, pathology was stratified as either proximal or distal to the sigmoid/descending junction. Substantial pathology was defined as one or more adenomas > 8 mm, carcinoma, or colitis. RESULTS: Anoscopy demonstrated internal and external hemorrhoids in 78 and 29 patients, respectively. On colonoscopy, 36 patients had 43 substantial lesions. Thirty-seven of these lesions were distal to the junction of the descending and sigmoid colons and six were proximal lesions. Four patients had cancer; all were distal lesions. Patients with substantial lesions were more likely to give a history of blood mixed within their stool (p = 0.03), to have more episodes of hematochezia per month (p = 0.008), and to have a significantly shorter duration of bleeding before medical evaluation (p = 0.02) than did patients without such lesions. However, the physician's clinical assessment did not predict reliably which patients were likely to have substantial pathology. CONCLUSIONS: In patients with hematochezia, clinicians were unable to distinguish between those patients with and those without significant colonic lesions by history alone. Flexible sigmoidoscopy would have demonstrated most (95%) substantial lesions. The lesions that flexible sigmoidoscopy missed were an unlikely cause of bleeding in this small group of patients.

Endoscopic management of esophageal variceal hemorrhage: injection, banding, glue, octreotide, or a combination?

Bleeding from esophageal varices presents a considerable challenge to clinicians. Adequate fluid resuscitation must be undertaken before urgent endoscopy. Pharmacotherapy of acute variceal hemorrhage consists of either vasopressin plus nitroglycerin or intravenous octreotide. Vasopressin should not be used alone because of a high incidence of side effects such as cardiac and/or visceral ischemia. Band ligation appears superior to sclerotherapy primarily because of decreased rebleeding from varices and decreased esophageal stricture formation among patients undergoing band ligation. Future trials with newer sclerosant agents, such as cyanoacrylate, are anxiously awaited.

Endoscopic sclerotherapy compared with percutaneous transjugular intrahepatic portosystemic shunt after initial sclerotherapy in patients with acute variceal hemorrhage. A randomized, controlled trial.

BACKGROUND: Hemorrhage from esophageal varices remains a substantial management problem. Endoscopic sclerotherapy was preferred for more than a decade, but fluoroscopically placed intrahepatic portosystemic stents have recently been used with increasing frequency. OBJECTIVE: To compare sclerotherapy with transjugular intrahepatic portosystemic shunt (TIPS) in patients with bleeding from esophageal varices. DESIGN: Randomized, controlled clinical trial. SETTING: Three teaching hospitals. PATIENTS: 49 adults hospitalized with acute variceal hemorrhage from November 1991 to December 1995: 25 assigned to sclerotherapy and 24 assigned to TIPS. INTERVENTION: Patients assigned to repeated sclerotherapy had the procedure weekly. In those assigned to TIPS, an expandable mesh stent was fluoroscopically placed between an intrahepatic portal vein and an adjacent hepatic vein. MEASUREMENTS: Pretreatment measures included demographic and laboratory data. Postrandomization data included index hospitalization survival, duration of follow-up, successful obliteration of varices, rebleeding from varices, number of variceal rebleeding events, total days of hospitalization for variceal bleeding, blood transfusion requirements after randomization, prevalence of encephalopathy, and total health care costs. RESULTS: Mean follow-up (+/-SE) was 567 +/- 104 days in the sclerotherapy group and 575 +/- 109 days in the TIPS group. Varices were obliterated more reliably by TIPS than by sclerotherapy (P < 0.001). Patients having TIPS were significantly less likely to rebleed from esophageal varices than patients receiving sclerotherapy (3 of 24 compared with 12 of 25; P = 0.012). No other follow-up measures differed significantly between groups. A trend toward improved survival, which was not statistically significant, was noted in the TIPS group (hazard ratio, 0.53 [95% CI, 0.18 to 1.5]). CONCLUSIONS: In obliterating varices and reducing rebleeding events from esophageal varies, TIPS was more effective than sclerotherapy. However, TIPS did not decrease morbidity after randomization or improve health care costs. It seemed to produce better survival, but the increase in survival was not statistically significant.