Efficacy and safety of CD24Fc in hospitalised patients with COVID-19: a randomised, double-blind, placebo-controlled, phase 3 study.

BACKGROUND: Non-antiviral therapeutic options are required for the treatment of hospitalised patients with COVID-19. CD24Fc is an immunomodulator with potential to reduce the exaggerated inflammatory response to tissue injuries. We aimed to evaluate the safety and efficacy of CD24Fc in hospitalised adults with COVID-19 receiving oxygen support. METHODS: We conducted a randomised, double-blind, placebo-controlled, phase 3 study at nine medical centres in the USA. Hospitalised patients (age ≥18 years) with confirmed SARS-CoV-2 infection who were receiving oxygen support and standard of care were randomly assigned (1:1) by site-stratified block randomisation to receive a single intravenous infusion of CD24Fc 480 mg or placebo. The study funder, investigators, and patients were masked to treatment group assignment. The primary endpoint was time to clinical improvement over 28 days, defined as time that elapsed between a baseline National Institute of Allergy and Infectious Diseases ordinal scale score of 2-4 and reaching a score of 5 or higher or hospital discharge. The prespecified primary interim analysis was done when 146 participants reached the time to clinical improvement endpoint. Efficacy was assessed in the intention-to-treat population. Safety was assessed in the as-treated population. This study is registered with ClinicalTrials.gov, NCT04317040. FINDINGS: Between April 24 and Sept 22, 2020, 243 hospitalised patients were assessed for eligibility and 234 were enrolled and randomly assigned to receive CD24Fc (n=116) or placebo (n=118). The prespecified interim analysis was done when 146 participants reached the time to clinical improvement endpoint among 197 randomised participants. In the interim analysis, the 28-day clinical improvement rate was 82% (81 of 99) for CD24Fc versus 66% (65 of 98) for placebo; median time to clinical improvement was 6·0 days (95% CI 5·0-8·0) in the CD24Fc group versus 10·0 days (7·0-15·0) in the placebo group (hazard ratio [HR] 1·61, 95% CI 1·16-2·23; log-rank p=0·0028, which crossed the prespecified efficacy boundary [α=0·0147]). 37 participants were randomly assigned after the interim analysis data cutoff date; among the 234 randomised participants, median time to clinical improvement was 6·0 days (95% CI 5·0-9·0) in the CD24Fc group versus 10·5 days (7·0-15·0) in the placebo group (HR 1·40, 95% CI 1·02-1·92; log-rank p=0·037). The proportion of participants with disease progression within 28 days was 19% (22 of 116) in the CD24Fc group versus 31% (36 of 118) in the placebo group (HR 0·56, 95% CI 0·33-0·95; unadjusted p=0·031). The incidences of adverse events and serious adverse events were similar in both groups. No treatment-related adverse events were observed. INTERPRETATION: CD24Fc is generally well tolerated and accelerates clinical improvement of hospitalised patients with COVID-19 who are receiving oxygen support. These data suggest that targeting inflammation in response to tissue injuries might provide a therapeutic option for patients hospitalised with COVID-19. FUNDING: Merck & Co, National Cancer Institute, OncoImmune.

Endoscopic Management of a Tubulovillous Adenoma Within a Diverticulum: Report of a Case and Review of Literature.

Adenomas or adenocarcinomas located within a colonic diverticulum are considered a rare phenomenon that has been described in the literature. These lesions are technically difficult to manage endoscopically and usually require surgical intervention for removal. There is also an increased risk of perforation upon endoscopic resection owing to the lack of a muscular layer within the diverticulum. We report a case and include a literature review to evaluate different endoscopic techniques and propose the most effective for management of adenomas within a diverticulum. This technique is potentially comprised of employing a combined approach using a suction banding device, an over-the-scope clip (OTSC; Ovesco Endoscopy AG, Tübingen, Germany) , and hyperthemic snare to successfully remove the polyp, ensure tissue retrieval, and reduce risk of iatrogenic colonic perforation.

The band and slough technique is effective for management of diminutive type 1 gastric and duodenal neuroendocrine tumors.

Background and study aims Endoscopic resection is recommended as initial treatment for early-stage gastric and duodenal neuroendocrine tumors (G-NETs and D-NETs). However, it can cause serious adverse events. We aimed to evaluate the efficacy and safety of the band and slough (BAS) technique as a novel and less aggressive endoscopic therapy for management of such tumors. Four patients, three diagnosed with < 10-mm D-NET and one with 10-mm type I G-NET, were treated with the BAS technique without endoscopic resection. Initial follow-up endoscopy at 3 months was done to assess for residual tumor. Subsequent endoscopic surveillance was performed. After one session of banding, all patients achieved complete remission at 3-month follow-up. No tumor recurrence was detected on repeat biopsy at 12-month surveillance endoscopy. None of the patients developed any adverse events including bleeding or perforation. The BAS technique may prove to be a safe and effective endoscopic therapy for diminutive, non-metastatic type 1 G-NETs and D-NETs. Studies of larger scale and longer follow-up periods are needed to corroborate these findings.

Multiple gastric metastases from ovarian carcinoma diagnosed by endoscopic ultrasound with fine needle aspiration.

Metastasis to the stomach from nongastric tumors is a rare event. We present a case of ovarian cancer metastasis to the gastric wall that presented as multiple subepithelial gastric lesions. A 55-year-old female with known stage III b serous ovarian cancer was admitted to the hospital with melena and anemia. A 1.5 to 2 cm subepithelial mass with superficial overlying erosion in the antrum was seen in Esophagogastroduodenoscopy (EGD). Initial endoscopic mucosal biopsies were normal. An Endoscopic Ultrasound (EUS) was performed, which revealed two subepithelial lesions with the typical appearance of a gastrointestinal stromal tumor. Fine needle aspiration (FNA) of both masses revealed papillary adenocarcinoma from an ovarian papillary serous adenocarcinoma. This is the first reported case of multiple gastric metastatic lesions from ovarian cancer diagnosed by EUS FNA.

Rapidly progressive metastatic multicentric epithelioid angiosarcoma of the small bowel: a case report and a review of literature.

BACKGROUND: Angiosarcoma is a rare high-grade neoplasm that frequently involves the skin and subcutaneous tissue. Rarely, angiosarcoma can occur in the gastrointestinal tract where it frequently exhibits multicentric epithelioid morphology. DESIGN: We report a case of multicentric epithelioid angiosarcoma (EAS) of the small intestine in a 73-year-old male patient who presented with weakness and melena, and was found to have bleeding lesions in the small intestine on upper gastrointestinal endoscopy. In addition to this case, we extensively reviewed the clinical and pathological features of previously reported cases of angiosarcoma of the small intestine in the English literature since 1970. RESULTS: Our patient presented with rare and aggressive EAS of the small intestine. Despite surgical resection of the lesions, the patient continued to worsen and developed rapidly progressive metastatic disease. He died within 4 months of the diagnosis. CONCLUSIONS: Angiosarcoma, especially of the deep tissues and the gastrointestinal tract, is very aggressive and rapidly metastatic. The survival rate in these patients is extremely poor, and most patients die within 6 months to 1 year of the diagnosis. Treatment usually involves surgical resection of the bleeding lesions and frequent blood transfusions for symptom alleviation.

Phase 2 study of pegylated liposomal doxorubicin in combination with interleukin-12 for AIDS-related Kaposi sarcoma.

Thirty-six patients with AIDS-associated Kaposi sarcoma (KS) requiring chemotherapy were treated for six 3-week cycles of pegylated liposomal doxorubicin (20 mg/m(2)) plus interleukin-12 (IL-12; 300 ng/kg subcutaneously twice weekly), followed by 500 ng/kg subcutaneous IL-12 twice weekly for up to 3 years. All received highly active antiretroviral therapy (HAART). Twenty-two had poor-prognosis KS (T(1)S(1)). Thirty patients had a major response, including 9 with complete response, yielding an 83.3% major response rate (95% confidence interval: 67.2%-93.6%). Median time to first response was 2 cycles. Median progression was not reached at median potential follow-up of 46.9 months. Of 27 patients with residual disease when starting maintenance IL-12, 15 had a new major response compared with this new baseline. The regimen was overall well tolerated; principal toxicities were neutropenia, anemia, transaminitis, and neuropsychiatric toxicity. Patients had increases in serum IL-12, interferon gamma, and inducible protein-10 (IP-10), and these remained increased at weeks 18 and 34. The regimen of IL-12 plus liposomal doxorubicin yielded rapid tumor responses and a high response rate in patients with AIDS-KS receiving HAART, and responses were sustained on IL-12 maintenance therapy. A randomized trial of IL-12 in this setting may be warranted. This study is registered at (http://www.clinicaltrials.gov) as no. NCT00020449.

Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine.

Needle-free delivery of a six-plasmid HIV-1 DNA vaccine encoding EnvA, EnvB, EnvC, and subtype B Gag, Pol, and Nef underwent open-label evaluation in 15 subjects; 14 completed the 0, 1, 2 month vaccination schedule. T cell responses to HIV-specific peptide pools were detected by intracellular cytokine staining of CD4(+) [13/14 (93%)] and CD8(+) [5/14 (36%)], and by ELISpot in 11/14 (79%). Ten of 14 (71%) had ELISA antibody responses to Env proteins. Compared to a four-plasmid product, Gag- and Nef-specific T cell responses were improved, while Env-specific responses were maintained. This candidate vaccine has now advanced to Phase II evaluation.

Gastroesophageal reflux disease-associated esophagitis induces endogenous cytokine production leading to motor abnormalities.

BACKGROUND & AIMS: Gastroesophageal reflux disease is a condition frequently associated with esophagitis and motor abnormalities. Recent evidence suggests that proinflammatory cytokines, such as interleukin (IL)-1beta and IL-6, may be implicated because they reduce esophageal muscle contractility, but these results derive from in vitro or animal models of esophagitis. This study used human esophageal cells and tissues to identify the cellular source of cytokines in human esophagitis investigate whether cytokines can be induced by gastric refluxate, and examine whether esophageal tissue- or cell-derived mediators affect muscle contractility. METHODS: Endoscopic mucosal biopsy specimens were obtained from patients with and without esophagitis, organ-cultured, and undernatants were assessed for cytokine content. The cytokine profile of esophageal epithelial, fibroblast, and muscle cells was analyzed, and esophageal mucosa and cell products were tested in an esophageal circular muscle contraction assay. RESULTS: The mucosa of esophagitis patients produced significantly greater amounts of IL-1beta and IL-6 compared with those of control patients. Cultured esophageal epithelial cells produced IL-6, as did fibroblasts and muscle cells. Epithelial cells exposed to buffered, but not denatured, gastric juice produced IL-6. Undernatants of mucosal biopsy cultures from esophagitis patients reduced esophageal muscle contraction, as did supernatants from esophageal epithelial cell cultures. CONCLUSIONS: The human esophagus produces cytokines capable of reducing contractility of esophageal muscle cells. Exposure to gastric juice is sufficient to stimulate esophageal epithelial cells to produce IL-6, a cytokine able to alter esophageal contractility. These results indicate that classic cytokines are important mediators of the motor disturbances associated with human esophageal inflammation.

Treatment of AIDS-related Kaposi's sarcoma with interleukin-12: rationale and preliminary evidence of clinical activity.

In this article, we review the preliminary evidence for the activity of interleukin-12 (IL-12) against Kaposi's sarcoma (KS) and discuss these results in the context of the biology of IL-12 and KS. IL-12 is a cytokine that enhances type 1 immunity, induces production of interferon gamma (IFN-gamma), and mediates antiangiogenic effects. In addition, it can downregulate a constitutively active G protein coupled receptor that is encoded by Kaposi's sarcoma-associated herpesvirus, the causative agent of KS. These factors suggested that IL-12 might be worth exploring as a potential anti-KS agent. In an initial phase I pilot study, IL-12 was found to have anti-KS activity when used alone in patients with AIDS-associated KS who were on a stable regimen of antiretroviral therapy. In preliminary results from a subsequent study of the combination of IL-12 plus liposomal doxorubicin along with highly active antiretroviral therapy, remissions were obtained in a substantial percentage of patients with advanced AIDS-associated KS. IL-12 has also been found active in patients with certain lymphomas. These results suggest that IL-12 may be worth exploring further as a potential antitumor agent in selected tumors.

Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector.

BACKGROUND: The development of an effective human immunodeficiency virus (HIV) vaccine is a high global priority. Here, we report the safety, tolerability, and immunogenicity of a replication-defective recombinant adenovirus serotype 5 (rAd5) vector HIV-1 candidate vaccine. METHODS: The vaccine is a mixture of 4 rAd5 vectors that express HIV-1 subtype B Gag-Pol fusion protein and envelope (Env) from subtypes A, B, and C. Healthy, uninfected adults were randomized to receive 1 intramuscular injection of placebo (n=6) or vaccine at dose levels of 10(9) (n=10), 10(10) (n=10), or 10(11) (n=10) particle units and were followed for 24 weeks to assess immunogenicity and safety. RESULTS: The vaccine was well tolerated but was associated with more reactogenicity at the highest dose. At week 4, vaccine antigen-specific T cell responses were detected in 28 (93.3%) and 18 (60%) of 30 vaccine recipients for CD4(+) and CD8(+) T cells, respectively, by intracellular cytokine staining assay and in 22 (73%) of 30 vaccine recipients by enzyme-linked immunospot assay. Env-specific antibody responses were detected in 15 (50%) of 30 vaccine recipients by enzyme-linked immunosorbant assay and in 28 (93.3%) of 30 vaccine recipients by immunoprecipitation followed by Western blotting. No neutralizing antibody was detected. CONCLUSIONS: A single injection induced HIV-1 antigen-specific CD4(+) T cell, CD8(+) T cell, and antibody responses in the majority of vaccine recipients. This multiclade rAd5 HIV-1 vaccine is now being evaluated in combination with a multiclade HIV-1 DNA plasmid vaccine.

Possible therapeutic vaccine strategy against human immunodeficiency virus escape from reverse transcriptase inhibitors studied in HLA-A2 transgenic mice.

Mutation of human immunodeficiency virus (HIV) leading to escape from anti-HIV drugs is the greatest challenge to the treatment of HIV infection. High-grade resistance to the nucleoside reverse transcriptase (RT) inhibitor lamivudine (also known as 3TC) is associated with a substitution of valine for methionine at position 184 of RT. This amino acid residue is contained within the HLA-A2-restricted epitope VIYQYMDDL (RT-WT). Here, we sought to determine whether a peptide vaccine could be developed using an epitope enhancement strategy that could induce a cytotoxic T-lymphocyte (CTL) response specific for an epitope containing the drug resistance mutation M184V to exert an opposing selective pressure. RT-WT-specific CTLs developed from HLA-A2 transgenic mice did not recognize the M184V mutation of RT-WT (RT-M184V). However, RT-M184V exhibited higher binding affinity for HLA-A2 than RT-WT. Also, both anchor-enhanced RT-WT (RT-2L9V) and RT-2L9V-M184V-specific CTLs recognized RT-M184V and displayed cross-reactivity to RT-WT. Nevertheless, the CTL repertoire elicited by the epitope-enhanced RT-2L9V-M184V appeared more selective for the RT inhibitor-induced M184V mutation. Peptide vaccines based on such strategies may be worth testing for their ability to exert selective pressure against drug-resistant strains and thus delay or prevent the development of HIV with the M184V resistance mutation.

Activity of subcutaneous interleukin-12 in AIDS-related Kaposi sarcoma.

Interleukin-12 (IL-12) enhances Th1-type T-cell responses and exerts antiangiogenic effects. We initiated a phase 1 pilot study of IL-12 in 32 patients with acquired immunodeficiency syndrome (AIDS)-related Kaposi sarcoma (KS) whose KS was progressing while on antiretroviral therapy. Fifteen patients had poor prognosis T(1)S(1) disease. IL-12 was administered subcutaneously twice weekly at doses from 100 to 625 ng/kg. The maximum tolerated dose was 500 ng/kg, and the principal toxicities were flulike symptoms, transaminase or bilirubin elevations, neutropenia, hemolytic anemia, and depression. No tumor responses were seen at the lowest dose (100 ng/kg), but 17 of 24 evaluable patients at the higher doses had partial or complete responses (response rate, 71%; 95% confidence interval, 48%-89%). Only 3 of 17 patients had a change in antiretroviral therapy before responding, and there were no significant differences between responders and nonresponders with regard to changes in CD4 counts or viral loads. Patients had increases in their serum IL-12, interferon-gamma, and inducible protein-10 (IP-10) after the first dose, and increases above baseline persisted after week 4. These results provide preliminary evidence that IL-12 has substantial activity against AIDS-related KS with acceptable toxicity and warrants further investigation for this indication.

Predictors of cancer in patients with suspected pancreatic malignancy without a tissue diagnosis.

BACKGROUND: The aim of this study was to identify predictive factors for malignancy in patients undergoing surgery for suspected pancreatic cancer without a preoperative tissue diagnosis. METHODS: Patients were identified by International Classification of Diseases Ninth Revision and current procedural terminology codes, respectively, for pancreatic cancer and pancreaticoduodenectomy at a single tertiary referral center between January 1998 and May 2004. Data were collected retrospectively by chart review. Multivariate analysis of potential predictive factors was performed. RESULTS: A total of 150 patients underwent surgery for documented or suspected pancreatic malignancy; 102 did not have a preoperative tissue diagnosis of cancer. Of these, 75 had neoplastic disease at surgery. Average weight loss was greater for those with malignancy (13.5 vs. 4.8 lbs; P = .014) as was mean bilirubin (6.1 vs. 3.3 mg/dL; P = .006). In multivariate analysis, a combination of weight loss >20 lbs, bilirubin >3 mg/dL, and CA 19-9 >37 U/mL had both a specificity and positive predictive value of 100% for predicting malignancy regardless of bile duct abnormalities or mass lesions on endoscopic retrograde cholangiopancreatography or endoscopic ultrasound, respectively. The positive predictive value decreased to 89.5% when any 2 of these findings were present. The presence of a mass on CT or EUS alone had a sensitivity of 84%; however, no other single finding had a sensitivity >65%. CONCLUSIONS: In patients suspected of having a pancreatic malignancy, weight loss, hyperbilirubinemia, and increased CA 19-9 level may be predictive of a final cancer diagnosis. Surgical exploration should be considered in these patients even in the absence of a preoperative tissue diagnosis.

Long-term follow-up of patients with clinically indeterminate suspicion of pancreatic cancer and normal EUS.

BACKGROUND: EUS often is performed because of a clinical suspicion of pancreatic cancer when the results of other noninvasive diagnostic tests are indeterminate. The aim of this study was to determine the true negative predictive value of a normal EUS in a cohort of patients with an indeterminate suspicion of pancreatic cancer by obtaining long-term follow-up information. METHODS: Patients referred for EUS of the pancreas for the following indications were identified: elevated carbohydrate-associated antigen (CA 19-9) without other definitive evidence of pancreatic cancer, subtle abnormalities on CT of the pancreas, and unexplained abdominal pain and/or weight loss. Endoscopy procedure reports, as well as inpatient and outpatient records were obtained. In addition, referring physicians, as well as patients, were contacted to acquire adequate follow-up information. RESULTS: A total of 80 patients were included in the study. Follow-up of at least 6 months was obtained for 76 (95%) patients (mean follow-up 23.9 months). No patient with a normal EUS of the pancreas developed pancreatic cancer or required pancreatic surgery during the follow-up period. One patient in whom a diagnosis of chronic pancreatitis was made by EUS subsequently was found to have pancreatic cancer at surgery. CONCLUSIONS: A normal EUS of the pancreas in the setting of subtle radiologic findings, serologic abnormalities, and/or nonspecific symptoms definitively rules out the presence of pancreatic cancer.

Prospective evaluation of 4-mm diameter endoscopes for esophagoscopy in sedated and unsedated patients.

BACKGROUND: Unsedated esophagoscopy with small-diameter endoscopes is generally well tolerated but of limited sensitivity for the diagnosis of esophageal mucosal disease. This study evaluated the sensitivity of esophagoscopy performed with new 4-mm diameter prototype battery-powered and video endoscopes. Patient tolerance for an unsedated examination with the 4-mm endoscopes was assessed and the performance characteristics of the battery-powered and video 4-mm endoscopes were compared. METHODS: Patients referred for EGD were recruited to undergo an additional examination with a 4-mm endoscope. A prototype 60-cm long, 4-mm diameter battery-powered fiberoptic esophagoscope was used in the first 24 patients and a prototype 60-cm long, 4-mm diameter video esophagoscope in the next 27 patients. Examiners who were unaware of patient history and procedure indications recorded esophageal findings, ease of intubation, optical quality (5-point visual scale), and time for examination of the esophagus and then recorded esophageal findings after the standard EGD. RESULTS: The sensitivity, specificity, and accuracy for identification of Barrett's esophagus was 100%; overall sensitivity, accuracy, and specificity for detecting esophageal lesions were, respectively, 91%, 98%, and 99%. Patient tolerance (assessed by symptom scores for choking, pain, and discomfort) and acceptability of unsedated esophagoscopy with the 4-mm diameter instruments were significantly better than in a historical group of patients examined with a 3-mm diameter endoscope. The optical quality of video endoscope was rated as superior to that of battery-powered endoscope, and esophageal examination was performed significantly quicker with the video versus the battery-powered endoscope (68 vs. 137 seconds; p = 0.001). CONCLUSIONS: Unsedated esophagoscopy with 4-mm diameter endoscopes may be an alternative to EGD for screening for Barrett's esophagus. Given the current state of endoscopic technology, a minimum diameter of 4 mm is required for satisfactory esophageal imaging.

Innovative methods of biliary tract diagnosis: intraductal ultrasound and tissue acquisition.

Tissue can be acquired from the bile and pancreatic duct with either brush cytology or biopsy forceps, often without the need for sphincterotomy. Although the diagnosis of malignancy with these sampling techniques is often specific, the sensitivity is limited, and a wide range of diagnostic accuracies has been reported. A combination of biopsy and brush cytology along with some newer techniques in the development stage may increase the sensitivity. Intraductal ultrasound is a newer technique offers the endoscopist the ability to image the bile and pancreatic duct wall, adjacent organs, and vascular structures with a high degree of detail. This visualization can be accomplished during the course of an ERCP or percutaneously under fluoroscopic guidance. Indications for the procedure include detection of choledocholithiasis, differentiation of benign and malignant ductal strictures, pancreaticobiliary tumor staging, and detection of various pancreatic tumors. Continued research into the design of the probes, which could improve durability and extend the depth of penetration, may promote more widespread use of this novel technology.

Patient tolerance and acceptance of unsedated ultrathin esophagoscopy.

BACKGROUND: Unsedated endoscopy has not gained wide acceptance in the United States. Factors that may predict tolerance and acceptance of unsedated endoscopy are ill defined. METHODS: Outpatients referred for standard EGD were recruited to undergo unsedated ultrathin esophagoscopy (UUE) with a new 3.1-mm battery-powered esophagoscope before sedated EGD. They rated preprocedure and postprocedure anxiety levels with the Profile of Mood States Tension/Anxiety subscale (POMS-SF T/A). They also rated symptoms and overall acceptability and listed procedural preference between EGD and UUE. Patients who refused UUE noted a reason for refusal and also completed the anxiety questionnaire. RESULTS: Fifty-two of 98 patients recruited agreed to participate, and underwent both UUE and EGD. Patients who refused UUE were significantly more anxious (mean anxiety score, 8.2 vs. 4.5, p < 0.005). Participants reported no significant difference between preprocedural (4.6 vs. 5.3) or postprocedural (3.5 vs. 2.6) anxiety for UUE versus standard EGD. After undergoing both procedures, only 46% stated they would prefer UUE to EGD in the future. Patients who chose the peroral approach were more likely to prefer UUE than those who chose the transnasal approach (58% vs. 23%, p = 0.02). CONCLUSIONS: Patient acceptance of unsedated endoscopy even with an ultrathin instrument is limited. Anxiety assessment by the POMS-SF T/A can identify patients willing to undergo UUE. Patients who choose transoral UUE may be more willing to repeat the procedure.

Accuracy of a narrow-diameter battery-powered endoscope in sedated and unsedated patients.

BACKGROUND: Esophagoscopy with a portable battery-powered endoscope could provide a safe, inexpensive, and minimally invasive way to screen for Barrett's esophagus or esophageal varices. The use of such an instrument in an unsedated fashion has not been previously evaluated. METHODS: Patients referred for an EGD were recruited to undergo an additional examination with the battery-powered endoscope before EGD. In phase 1, (n = 42) patients received conscious sedation before the battery-powered endoscopic examination. In phase 2, (n = 56) patients were not sedated and were given the option of a peroral (n = 43) or transnasal (n = 13) endoscopy. Examiners were blinded to patient history and procedure indications. Esophageal findings, ease of intubation, optical quality, and patient comfort for the battery-powered endoscope and standard EGD were recorded by the endoscopist. RESULTS: Ninety-eight patients (60 men, 38 women, mean age 53 years) were recruited. The sensitivity for detecting Barrett's esophagus, esophageal tumors, and esophageal varices was 54.5%, 66.7%, and 80%, respectively. Ease of intubation and patient comfort as perceived by the endoscopist were not significantly different between the battery-powered endoscope and EGD. Optical quality was ranked as less than 4 (on a 5-point scale with 5 = standard EGD and 1 = poor) in 42% of battery-powered endoscopic examinations. There were no complications. CONCLUSION: The accuracy of esophageal examination with a 3.1-mm endoscope is substantially inferior to standard EGD. Thus, the battery-powered endoscope would not be useful for screening patients for Barrett's esophagus or varices unless improvements in optical quality and visualization are made.