A prospective, blinded study of diagnostic esophagoscopy with a superthin, stand-alone, battery-powered esophagoscope.

OBJECTIVES: A more widely available, well-tolerated, and cost-effective technique is needed to screen a broad population at risk for esophageal cancer. An ideal solution might be to perform unsedated esophagoscopy with an entirely self-contained, small-caliber endoscope. In a prospective, blinded study in three phases, we compared the feasibility, patient tolerance, and diagnostic accuracy of esophagoscopy performed with a prototype, superthin, battery-powered esophagoscope (BPE) with standard video esophagogastroduodenoscopy (SVE). METHODS: In phase I, 10 healthy volunteers underwent both peroral and transnasal esophagoscopy with BPE to evaluate the technical feasibility of the examination. For phases II and III, patients were recruited to have BPE before SVE. In phase II, both procedures were performed with conscious sedation. In phase III, the BPE was performed with only topical anesthesia. Two endoscopists assessed the technical performance of the endoscope and patient tolerance and recorded the esophageal findings independently. RESULTS: In phase I, all endoscopists reported adequate visualization of the esophagus in the 10 volunteers. A total of 181 patients were evaluated in phases II and III (89 in phase II, 92 in phase III). The sensitivity for detecting columnar lined esophagus was 94% in phase II and 95% in phase III. The sensitivity for all esophageal findings was 87% and 86% in phases II and III, respectively. The technical performance of the endoscope was significantly worse for BPE compared with the SVE. The patient tolerance as evaluated by the endoscopist was similar for both procedures. Ninety-five percent of the patients undergoing unsedated BPE were willing to have the procedure repeated under similar circumstances. CONCLUSIONS: Unsedated esophagoscopy with a 3.1-mm, battery-powered, stand-alone esophagoscope is feasible, well tolerated, and accurate in detecting esophageal pathologies. It might be an efficient and cost-effective screening tool for the detection of columnar lined esophagus.

Prospective evaluation of a 3.1-mm battery-powered esophagoscope in screening for esophageal varices in cirrhotic patients.

OBJECTIVE: Standard esophagogastroduodenoscopy (EGD) is costly and uses conscious sedation that cirrhotic patients may tolerate poorly. This study aimed to determine the feasibility and acceptance of unsedated esophagoscopy with an ultrathin battery-powered endoscope (BPE) in cirrhotic patients for diagnosing esophageal varices (EV). METHODS: We first studied the prevalence of significant gastroduodenal pathology that could be missed if only esophagoscopy were performed in cirrhotic patients undergoing liver transplant evaluation. A prospective study was then done to evaluate a BPE in EV screening. Unsedated per-oral endoscopy was first done by a single endoscopist using a BPE, followed by EGD by a second endoscopist who was masked to the BPE result. A visual analog score was used to determine patient tolerance. Patients were asked about their preference for endoscopy in the future. A paired Student t test and the kappa statistic were used in the statistical analysis. RESULTS: In the retrospective study, 199 patients were reviewed; three patients (1.5%) had gastric ulcers, and two patients (1%) had duodenal ulcers. In the prospective study, 28 cirrhotic patients (16 women) were evaluated. EV were diagnosed in 14 patients with a BPE, and 13 were confirmed by standard EGD (sensitivity and negative predictive value 100%, specificity and positive predictive value 93%, kappa = 0.93). EV were graded as large in one and small in 13 patients with a BPE, but small varices diagnosed in one patient were not confirmed on EGD. Both procedures were well tolerated by all patients. Twenty-seven of 28 patients preferred unsedated endoscopy with a BPE over EGD. CONCLUSIONS: Unsedated endoscopy with a BPE is safe and well tolerated. The diagnostic accuracy of a BPE for diagnosing EV is the same as by EGD. Esophagoscopy with a BPE is a potential alternative to EGD for EV screening.

Accuracy of esophagoscopy performed by a non-physician endoscopist with a 4-mm diameter battery-powered endoscope.

BACKGROUND: A cost-effective technique is needed for screening of a broad population at risk for esophageal cancer. A solution would be to have non-physician endoscopists perform esophagoscopy with small-caliber battery-powered endoscopes. METHODS: In a prospective blinded study, the diagnostic accuracy of sedated esophagoscopy performed by a trained nurse practitioner with a battery-powered 4-mm diameter endoscope was compared with that for a sedated standard video-endoscopy performed by a gastroenterologist. Patients were recruited to undergo peroral esophagoscopy by the nurse practitioner followed by sedated standard endoscopy by the supervising gastroenterologist, each blinded to the findings of the other. Major esophageal findings of nurse practitioner and gastroenterologist were compared. RESULTS: Findings in 40 patients were analyzed. In 4 patients both endoscopists could not assess the presence or absence of columnar-lined esophagus because of severe erosive esophagitis (n = 3) or severe candida-esophagitis (n = 1). By using sedated standard endoscopy as the standard, on a per finding basis, esophagoscopy by the nurse practitioner had a sensitivity for columnar-lined esophagus of 89%: 95% CI [75%, 97%] and specificity of 96%: 95% CI [84%, 99%]. The missed columnar epithelium was a 3 x 3-mm island. For all lesions, the sensitivity of endoscopy performed by the nurse practitioner with the battery-powered endoscope was 75%: 95% CI [67%, 82%] and specificity 98%: 95% CI [96%, 99%]. The nurse practitioner missed all of 4 rings (3 considered clinically irrelevant). CONCLUSION: Esophagoscopy with a battery-powered 4-mm diameter endoscope by a non-physician endoscopist is feasible and accurate in detecting esophageal pathologies. It may be an efficient screening method for the detection of columnar-lined esophagus. There was a distinct underestimate of the presence of esophageal rings.

Cost-effectiveness of screening a population with chronic gastroesophageal reflux.

BACKGROUND: Persons with chronic esophageal reflux are at increased risk for the development of Barrett's esophagus and adenocarcinoma. Recently developed ultrathin endoscopes are less expensive and better tolerated than standard endoscopes, they can be used without sedation, and are sensitive and specific for Barrett's esophagus. The cost-effectiveness of one-time screening strategies were evaluated for 50-year-old patients with chronic reflux: no screening, standard endoscopy, and screening by an ultrathin endoscope. METHODS: Markov models were created to simulate the clinical course for patients with chronic reflux. Costs and quality-adjusted life-years were estimated from cancer registry data, published medical data, and expert opinion. RESULTS: Under baseline assumptions, no screening resulted in average costs of $11,785 per person and 19.3226 quality-adjusted life-years. Ultrathin endoscopy screening resulted in costs of $12,119 per person and 19.3326 quality-adjusted life-years, yielding a marginal cost-effectiveness ratio of $55,764 per quality-adjusted life-year. Using standard endoscopy yielded costs of $12,332 with only slightly greater effectiveness, yielding a marginal cost-effectiveness ratio of $709,260 when compared with ultrathin endoscopy and $86,833 compared with no screening. Results were most sensitive to variation in the incidence of cancer in the population with Barrett's esophagus. CONCLUSIONS: Screening for Barrett's esophagus with ultrathin endoscopy is more cost-effective than standard endoscopy, and both strategies appear to improve quality-adjusted life-years among patients with chronic reflux at costs that are similar to those of other accepted preventive measures.