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Background: The over-the-scope clip (OTSC) provides more durable and full-thickness closure as compared with standard clips. Only case reports and small case series have reported on outcomes of OTSC closure of GI defects. Objective: To describe a large, multicenter experience with OTSCs for the management of GI defects. Secondary goals were to determine success rate by type of defect and type of therapy and to determine predictors of treatment outcomes. Design: Multicenter, retrospective study. Setting: Multiple, international, academic centers. Patients: Consecutive patients who underwent attempted OTSC placement for GI defects, either as a primary or as a rescue therapy. Interventions: OTSC placement to attempt closure of GI defects. Main Outcome Measurements: Long-term success of the procedure. Results: A total of 188 patients (108 fistulae, 48 perforations, 32 leaks) were included. Long-term success was achieved in 60.2% of patients during a median follow-up of 146 days. Rate of successful closure of perforations (90%) and leaks (73.3%) was significantly higher than that of fistulae (42.9%) (P < .05). Long-term success was significantly higher when OTSCs were applied as primary therapy (primary 69.1% vs rescue 46.9%; P = .004). On multivariate analysis, patients who had OTSC placement for perforations and leaks had significantly higher long-term success compared with those who had fistulae (OR 51.4 and 8.36, respectively). Limitations: Retrospective design and multiple operators with variable expertise with the OTSC device. Conclusion: OTSC is safe and effective therapy for closure of GI defects. Clinical success is best achieved in patients undergoing closure of perforations or leaks when OTSC is used for primary or rescue therapy. Type of defect is the best predictor of successful long-term closure.

Background A redundant colon can lead to incomplete colonoscopy. A variety of tools and techniques are available to complete colonoscopy but have limitations. Objective To determine the feasibility and safety of using a spiral overtube to complete a difficult colonoscopy. Design Retrospective review of a prospectively collected database. Setting Single tertiary institution. Patients Twenty-four patients with incomplete colonoscopy because of redundant colons underwent 26 procedures. The median age was 68 years, and 58% were men. Interventions All patients underwent colonoscopy performed with a 90-cm flexible threaded overtube and a variable-stiffness pediatric colonoscope. Four individuals (18%) required exchanging the colonoscope for an enteroscope. Main Outcome Measurements Successful cecal intubation, polyp identification and removal, time to reach the cecum, sedation needed, and complications. Results Cecal intubation was achieved in 22 patients (92%). Failures occurred in 2 patients with large hernias. The median time from insertion of the colonoscope to reaching the cecum was 14.5 minutes. All procedures were performed by using conscious sedation with midazolam (median dose 7 mg) and fentanyl (median dose 150 μg). Significant findings were encountered in 17 of 22 patients (77%) including 1 cancer and 2 advanced polyps. A median of 3 polyps was removed from each patient who had polyps. All noncancerous polyps were removed during the procedure. There were no complications. Limitations Retrospective design, no control group, single center. Conclusion Spiral overtube–assisted colonoscopy can enable cecal intubation in the majority of patients in whom standard colonoscopy fails because of a redundant colon.

Background Tumors arising from the duodenal papilla account for approximately 5% of GI neoplasms, but are increasingly identified. Objective To describe the clinical characteristics and outcomes in a large single-center experience with patients referred for ampullary lesions. Design A retrospective review of the Virginia Mason Medical Center endoscopy and hospital service database. Setting Tertiary referral center. Patients One hundred ninety-three patients referred for ampullary lesions from 1997 to 2007. Interventions Endoscopic management of ampullary lesions. Main Outcome Measurements The relationship of demographic and clinical data with endoscopic treatment and clinical outcomes in these patients. Results One hundred ninety-three patients underwent endoscopy for ampullary lesions. Fifteen juxta-ampullary lesions and 10 normal variants were excluded. Among 168 patients, there were 112 (67%) adenomas, 38 (23%) adenocarcinomas, and 18 (10%) nonadenomatous lesions. There were 88 men and 80 women, with a mean age of 64 years. Clinical presentation included cholestasis/cholangitis (72 patients), abdominal pain (54 patients), incidental/asymptomatic (51 patients), pancreatitis (9 patients), and bleeding (7 patients). Of the 57 patients referred to surgery, 42 were sent directly without papillectomy, and 16 were sent after papillectomy. Papillectomies were performed in 102 patients with adenomatous lesions. The mean tumor size was 2.4 cm (range 0.5-6 cm). The papillectomy complication rate was 21%: mild pancreatitis in 10 (10%) patients, cholangitis in 1, retroperitoneal perforation in 1 (adenocarcinoma), intraperitoneal perforation in 1 (lateral extension), bleeding in 5 (lateral extension in 2 of these 5), and delayed papillary stenosis in 3. Recurrences were seen in 8%. The endoscopic success rate was 84%. Factors affecting success were a smaller adenoma size and the absence of dilated ducts. Conclusions Most ampullary adenomas are amenable to endoscopy. Underlying malignancy and lateral extension may be risk factors for bleeding and perforation. Smaller lesion size and the absence of dilated ducts are factors favorably affecting success.

Endoscopic therapies for early neoplasia in Barrett's esophagus may be a viable alternative to esophagectomy.Our purpose was to compare endoscopic therapy and esophagectomy.Retrospective review from a single institution.A medium-sized tertiary referral center.All patients with Barrett's esophagus and dysplasia or intramucosal carcinoma treated by photodynamic therapy (PDT), EMR, or argon plasma coagulation (APC) or esophagectomy with curative intent from May 1998 until November 2005.Survival, progression to cancer, eradication of dysplasia and Barrett's esophagus, major and minor complications, and costs were compared.Sixty-two patients who underwent endoscopic therapy (2 APC alone, 18 EMR + APC, 20 PDT + APC, and 22 EMR + PDT + APC) and 32 patients who underwent esophagectomy met the inclusion criteria. The 30-day mortality rate included 1 patient in the endotherapy group (2%) and none in the surgical group (P = .49). No deaths from esophageal cancer occurred in either group. Cancer developed in 6% of endotherapy patients and in none in the surgical cohort (P.05). Major and minor complications occurred in 8% and 31% of endotherapy patients, respectively, and 13% and 63% of surgery patients (P = .50, P.001). Median cost to date was $40,079 for endotherapy and $66,060 for esophagectomy (P.001).Retrospective study, relatively short follow-up, small numbers.Both endotherapy and esophagectomy can effectively treat high-grade dysplasia and intramucosal carcinoma associated with Barrett's esophagus. Endotherapy is associated with a higher risk of tumor progression, although this is uncommon. Esophagectomy incurs higher initial costs and results in more frequent minor complications but is usually curative.

Many endoscopy units administer patient satisfaction surveys. We hypothesized that the survey collection method would affect satisfaction scores.To compare satisfaction scores obtained by using on-site (OS) surveys versus mail-back (MB) surveys.Quasi-randomization based on alternating weeks.Teaching hospital.Patients undergoing elective routine outpatient colonoscopy or upper endoscopy.Every patient was given an 11-question survey that asked about the patient's satisfaction with the nurses and the physician, wait times, the bowel-preparation process, patient education, procedural comfort, and sedation. Survey collection methods alternated weekly between an OS versus an MB method.Satisfaction scores on a Likert scale ranged from 1 (worst) to 7 (best).A total of 1698 subjects were included. The response rate was higher for the OS group (95%) than the MB group (62%). OS scores were significantly higher than MB scores for 5 of 11 questions, which concerned nurse satisfaction, physician satisfaction, bowel-preparation comfort, postprocedure education, and overall satisfaction (Bonferroni adjusted P.05 for all). Younger patients gave lower scores than older patients for all questions, whereas women gave significantly lower scores than men for bowel-preparation satisfaction.Lack of true randomization and formal validation of the satisfaction survey.Survey collection methods may bias not only response rates but also satisfaction scores. OS survey collection methods tend to result in higher satisfaction scores than MB methods. This bias should be noted when comparing scores among studies that used different survey collection methods.

Background Capsule impaction is a well-recognized complication of capsule endoscopy, with an incidence rate of 0.75% to 21%, depending on indication. There have been only 2 reported cases of capsule impaction causing symptomatic obstruction. Objective We present 3 cases of capsule impaction causing acute symptomatic obstruction and/or perforation. Design Case series. Setting Teaching hospital. Patients A 71-year-old woman had iron deficiency anemia in the setting of negative upper endoscopy, colonoscopy, enteroclysis, and enteroscopy. She developed severe abdominal pain, vomiting, and leukocytosis 20 hours after capsule ingestion. Emergent surgery was performed to remove the capsule, which was impacted at a previously undiagnosed ileal Crohn's stricture leading to perforation. A 64-year-old woman with Gardner's syndrome and a history of colectomy and subsequent episodes of small bowel obstruction underwent capsule endoscopy to define the site of obstruction. She experienced severe abdominal pain 24 hours after capsule ingestion, and emergent enteroscopy was done to retrieve the capsule, which was impacted at a previously undiagnosed annular mass in the distal duodenum. An 85-year-old man with episodic small bowel obstruction due to radiation enteritis underwent capsule endoscopy to localize the site of obstruction in anticipation of surgery. He returned with severe abdominal pain and vomiting 3 days later. At surgery, the capsule was found to be impacted at an ileal radiation stricture. Main Outcome Measurements Acute symptomatic bowel obstruction. Results These cases show that bowel obstruction and even possibly perforation can occur as a result of capsule impaction. Conclusions The possibility of acute symptomatic small bowel obstruction should be included in the informed consent for capsule endoscopy.

Background Performance parameters for double-balloon enteroscopy (DBE) have not been described. Objective To determine the learning curve for DBE. Design Prospective cohort study. Setting Six U.S. tertiary centers. Patients A total of 188 subjects undergoing 237 DBE procedures; 130 (69%) with obscure GI bleeding. Interventions Performance parameters from each center's initial 10 cases were compared to the subsequent examinations. Main Outcome Measurements Exam duration, depth of insertion, and findings on DBE examination. Results DBE was introduced by mouth in 149 (63%) cases, by rectum in 77 (33%) cases, and through a stoma in 6 (2.5%) patients. The mean (±SD) duration was 109.1 ± 44.6 minutes for the first 10 cases and 92.4 ± 37.6 minutes for subsequent cases ( P = .005) but did not change for rectal DBE procedures. There was no change in mean depth of insertion, but the mean fluoroscopy time declined significantly ( P = .025). Diagnostic or therapeutic maneuvers were performed in 64% of cases; DBE led to a diagnosis in 81 (43%) patients. A total of 78% of patients had prior capsule endoscopy (CE) with significant agreement between DBE and CE (κ = 0.74). One perforation occurred (0.4%). Per-rectal cases failed to reach the small bowel in 24 (31%) cases. Limitations All patients did not undergo initial CE. The therapeutic DBE scope was not available for the initial 8 months of the study. Conclusions There was a significant decline in overall procedural time and fluoroscopy time after the initial 10 DBE cases. There was no improvement in performance parameters when DBE was performed via the rectal approach despite increased, but limited, operator experience.

Background Double-balloon enteroscopy (DBE) is effective in visualizing the small bowel to perform biopsy sampling and interventions. Few studies have evaluated the utility of DBE in patients with known or suspected Crohn's disease (CD). Objective To evaluate the use of DBE in the diagnosis and impact on patient management in known and suspected CD and to compare capsule endoscopy (CE) with DBE findings. Design Retrospective study from August 2004 to August 2009 of DBE procedures. Setting Five academic, tertiary U.S. centers. Patients Patients with known or suspected CD. Main Outcome Measures Diagnostic yield, impact on patient management, and comparison of DBE to CE findings in patients with known and suspected CD. Results We analyzed 98 DBE procedures performed in 81 patients (38 with known CD and 43 with suspected CD). For patients with CD, common indications were abdominal pain and bleeding/anemia. The diagnostic yield was 87% (33/38 patients). The impact on subsequent management decisions was 82% (31/38). Common indications for DBE in patients with suspected CD were abnormal CE or other imaging. The diagnostic yield was 79% (34/43 patients). The impact on subsequent management decisions was 77% (33/43). In 17% of patients (14/81), DBE failed to reach the target lesion. There was 1 perforation, 3 strictures dilated, and 1 of 2 retained capsules recovered. When CE was followed by DBE, 46% of lesions were confirmed on DBE. Limitations Retrospective analysis, imperfect criterion standard. Conclusions DBE is an effective technique for assessment of the small bowel in known and suspected CD and affects management. Failure to reach target areas with DBE is not uncommon, and perforations can occur. There is poor correlation between CE and DBE.

Background: Recent studies have indicated that reusable biopsy forceps remain contaminated after reprocessing and can only be used a mean of 12 to 25 times without malfunction. Because this contradicts traditional endoscopic practice, our study investigated the ability to sterilize a type of commercially available biopsy forceps and prospectively evaluated their function in vivo until malfunction and/or breakage. Methods: Thirty reusable biopsy forceps were studied, 15 of which were contaminated for 5 trials each with 10 6 Bacillus stearothermophilus , and 15 of which were prospectively evaluated clinically over an 18-month period (9/98-3/00). Contaminated forceps were reprocessed by using a standard protocol and placed in a sterile bag containing soy broth. The latter was passed through a 0.2 μ filter and was subsequently cultured. In vivo data included biopsy site, size, adequacy, problems obtaining a biopsy specimen, and reasons for ultimate forceps failure. Results: After contamination, all biopsy forceps yielded a heavy growth of B stearothermophilus . No forceps, including 5 that were piecemeal dismantled with a wire cutter, had residual bacteria after reprocessing. In the in vivo study, 1507 biopsy sessions were undertaken in 1339 procedures. Forceps were categorized as new or like-new in 1259 of 1339 (94%) procedures, some loss of function but usable in 72 of 1339 (5.4%), and inadequate function or broken at use in 8 of 1339 (0.6%). Histologically, 1501 specimen sets were adequate (99.6%) and mean specimen size was 2.7 ± 0.1 mm. Mechanical problems were noted in only 38 of 1507 (3%) sessions to include such things as sticky forceps, and the mean number of uses to malfunction or breakage was 91 ± 15 (SEM) (range 19-132). Conclusions: This reusable biopsy forceps can be sterilized and used a mean of 91 times with adequate tissue sampling. Mechanical problems were minor to time of breakage. Contingent on acquisition and reprocessing costs as well as the number of procedures performed, this reusable forceps has the potential for significant cost savings. (Gastrointest Endosc 2001;53:747-50.)

Background Previous studies showed a correlation between mean withdrawal times during screening colonoscopy and polyp/neoplasia detection rates. Objectives To assess the effect of a monitoring and feedback program on withdrawal times, polyp/neoplasia detection rates, and patient satisfaction. Design Comparison of retrospective and prospective data. Setting Teaching hospital. Patients Asymptomatic adults undergoing screening colonoscopy. Interventions Monitoring and feedback program. Main Outcome Measurements Withdrawal times, polyp and neoplasia detection rates, and patient satisfaction scores. Methods We retrospectively reviewed 850 screening colonoscopies, recording withdrawal times, polyp findings, and patient satisfaction scores. All procedures were performed by 10 experienced gastroenterologists who were then informed that periodic confidential monitoring and feedback of withdrawal times, polyp detection rates, and satisfaction scores would be started. We then prospectively collected data on another 541 screening colonoscopies. We compared pre- and postmonitoring outcome measures. Results Overall, after monitoring had begun, there was an increase in mean withdrawal times (from 6.57 to 8.07 minutes; P P = .04, significance removed by Bonferroni correction). Nine of the 10 endoscopists increased their withdrawal times significantly. There was a small, nonsignificant increase in the neoplasia detection rate (from 19.6% to 22.7%; P = .17), but no significant change in mean satisfaction scores. Across endoscopists, there was a moderate correlation ( r = 0.63; P = .04, significance removed by Bonferroni correction) between withdrawal times and polyp detection rates, but not between withdrawal times and satisfaction scores. Limitations No randomization, possible response bias, confounding of intervention effects, and sample size limitations. Conclusions Monitoring and feedback are associated with increases in mean withdrawal times and polyp detection rates, but not patient satisfaction scores. Neoplasia detection rates showed a statistically nonsignificant trend toward an increase.

Background Esophageal capsule endoscopy (ECE) is an alternative to EGD for Barrett's esophagus screening. A multicenter study found ECE to be safe, well tolerated, and accurate; however, a post hoc adjudication process was used that may have biased results. Objective To assess the accuracy of ECE for the diagnosis of Barrett's esophagus. Design Prospective and blinded, with no adjudication. Patients Screening patients with chronic gastroesophageal reflux and surveillance patients with known Barrett's esophagus. Interventions ECE followed by EGD in each subject. Main Outcome Measurements Sensitivity, specificity, and positive and negative predictive values of ECE for Barrett's esophagus by using EGD results, with histologic confirmation as the criterion standard. Results Ninety-six subjects were enrolled, of whom 90 (94%) completed the study, including 66 screening and 24 surveillance patients. ECE was 67% sensitive and 84% specific for identifying Barrett's esophagus, diagnosing 14 of 21 cases of biopsy-confirmed Barrett's esophagus. Positive and negative predictive values were 22% and 98%, respectively (calculated for screening patients only). Sensitivity for short- and long-segment Barrett's esophagus was similar. Conclusions Our blinded, unadjudicated study shows that ECE had only moderate sensitivity and specificity for identifying Barrett's esophagus. ECE in its present form is not suitable as a primary screening tool for Barrett's esophagus but may be used in patients unwilling to undergo EGD. Inadequate visualization of the gastroesophageal junction may be the cause of suboptimal ECE accuracy; this may be improved by advances in ingestion protocol and capsule calibration.

The catheter probe EUS(C-EUS) relies on luminal water for acoustic coupling. However, in tubular structures, such as the esophagus and the duodenum, instilled water drains away rapidly. The use of water-filled balloons is limited by air artifact and other problems. This study evaluated the image quality, the penetration depth, the tumor staging accuracy, and the safety of C-EUS by using carboxymethylcellulose, an edible, nontoxic, transparent jelly-like substance (JC-EUS).Forty patients with an esophageal or a duodenal submucosal lesion or an esophageal carcinoma were evaluated prospectively in a crossover study with both C-EUS and JC-EUS when using a 12-MHz US catheter probe. Based on still images, depth of US penetration and image quality (by using a predefined 1 to 5 scale) were assessed by a blinded, independent endosonographer.JC-EUS was superior in image quality compared with C-EUS overall (mean score: 4.9 vs. 2.6; p0.001), as well as in each subgroup (esophageal carcinoma, esophageal submucosal lesion, duodenal submucosal lesion). Penetration depth was not significantly different (2.5 cm). Staging was 100% accurate in 14 patients with esophageal cancer who underwent surgery. There was no procedure-related complication.JC-EUS is safe, provides superior image quality to C-EUS, and is accurate for local staging of esophageal cancer.

antegrade approach). The average age of these patients was 83.5 years (Range 80-94 years). Indications and findings are described in the Table. The most common DBE indication was occult gastrointestinal bleeding (66%). The most common finding was non-bleeding mucosal vascular ectasias (42.6%). A therapeutic intervention (other than diagnostic biopsies) was performed in 134 (60%) procedures. Of the 137 patient’s a total of 114 (83.2%) of these had a capsule endoscopy prior to DBE. Correlation between findings of capsule endoscopy and DBE occurred in 78.9% (see Table). The overall diagnostic (pertinent positive findings) yield of DBE was 89.2%. The diagnostic yield of DBE for gastrointestinal bleeding (occult and overt) was 90.2%. There were no immediate (less than 48 hours) post-procedural complications. Conclusion: Capsule endoscopy has a very high correlation with DBE, and furthermore, DBE can be performed safely in the octogenarian patient population. Given these findings, in an elderly patient with positive findings on CE, DBE should be considered as the next appropriate diagnostic and therapeutic test.

Methemoglobin levels (mean D SD; range) Procedure Baseline MetHb Post-procedure MetHb Paired t-test EGD (n Z 38) 0.47 þ 0.14% (0.2-0.9%) 0.48 þ 0.16% (0.2-1.0%) P Z 0.77 TEE (n Z 29) 0.46 þ 0.19% (0.1-1.1%) 0.78 þ 1.41% (0.1-8.0%) P Z 0.2093

Use of a Self-Expanding, Removable, Plastic Stent (Polyflex ) for Esophageal Fistulae, Perforations and Benign and Malignant Strictures: Early Experience At a Single Institution Drew Schembre, Richard Kozarek Background: Traditionally, esophageal perforations, fistulae and recalcitrant strictures required surgical correction or placement of a permanent stent. A selfexpanding, plastic stent designed to be removed, (Polyflex Boston Scientific Inc., Boston), recently became available. We review our initial experience with the stent in a variety of esophageal situations. Methods: We reviewed all patients who received a Polyflex stent for an esophageal indication at our institution between 1/2004 and 11/2005. Indication for treatment, location, duration of placement, rate of migration and time to migration, complications and efficacy were recorded. Results: A total of 20 stents were successfully placed in 16 patients. 4 were placed for fistulae, 2 for perforations, 5 for malignant strictures, and 9 for benign strictures (6 anastamotic, 2 radiation and 1 caustic). Median follow-up was 12 months. 10 were placed in the proximal esophagus, 4 in the middle and 6 at the EG junction. 14 stents were eventually removed and 6 remained in place (3 for malignancy 3 anticipating removal). 4 stents migrated spontaneously (1 distally and 3 proximally). The median time in place was 4 weeks with a mean time to migration of 10 days. All stents that were removed, including migrated stents, came out easily with ‘‘rat’s tooth’’ forceps and slow, constant traction. None of the fistulae or perforations healed with stent placement. One fistula enlarged and one malignant stricture fistulized after stent removal. 8 stent placements resulted in at least temporary pain requiring narcotic analgesia. No deaths or other major complications occurred as a result of stent placement or removal. Of the 8 benign strictures in which the stent has been removed, 4 (50%) have experienced improvement of their dysphagia for at least 1 month. One patient who had 2 Polyflex stents placed for a caustic stricture has refused to return for stent removal, even after 12 months. Conclusion: Polyflex stents are easily placed and removed from the esophagus. Stent migration occurs occasionally, and may not occur for several days. Resolution of perforations and fistulae has been disappointing, but temporary stent placement can provide at least temporary relief of dysphagia from benign strictures.