Daniel C. DeMarco

Treating clostridium difficile infection with fecal microbiota transplantation

Clostridium difficile infection is increasing in incidence, severity, and mortality. Treatment options are limited and appear to be losing efficacy. Recurrent disease is especially challenging; extended treatment with oral vancomycin is becoming increasingly common but is expensive. Fecal microbiota transplantation is safe, inexpensive, and effective; according to case and small series reports, about 90% of patients are cured. We discuss the rationale, methods, and use of fecal microbiota transplantation.

Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: the TERRACE study

BACKGROUND Although colonoscopy is currently the optimal method for detecting colorectal polyps, some are missed. The Third Eye Retroscope provides an additional retrograde view that may detect polyps behind folds. OBJECTIVE To determine whether the addition of the Third Eye Retroscope to colonoscopy improves the adenoma detection rate. DESIGN Prospective, multicenter, randomized, controlled trial. SETTING Nine European and U.S. centers. PATIENTS Of 448 enrolled subjects, 395 had data for 2 procedures. INTERVENTIONS Subjects underwent same-day tandem examinations with standard colonoscopy (SC) and Third Eye colonoscopy (TEC). Subjects were randomized to SC followed by TEC or TEC followed by SC. MAIN OUTCOME MEASUREMENTS Detection rates for all polyps and adenomas with each method. RESULTS In the per-protocol population, 173 subjects underwent SC and then TEC, and TEC yielded 78 additional polyps (48.8%), including 49 adenomas (45.8%). In 176 subjects undergoing TEC and then SC, SC yielded 31 additional polyps (19.0%), including 26 adenomas (22.6%). Net additional detection rates with TEC were 29.8% for polyps and 23.2% for adenomas. The relative risk of missing with SC compared with TEC was 2.56 for polyps (P < .001) and 1.92 for adenomas (P = .029). Mean withdrawal times for SC and TEC were 7.58 and 9.52 minutes, respectively (P < .001). The median difference in withdrawal times was 1 minute (P < .001). The mean total procedure times for SC and TEC were 16.97 and 20.87 minutes, respectively (P < .001). LIMITATIONS Despite randomization and a large cohort, there was disparity in polyp prevalence between the 2 groups of subjects. CONCLUSION The Third Eye Retroscope increases adenoma detection rate by visualizing areas behind folds. ( CLINICAL TRIAL REGISTRATION NUMBER NCT01044732.).

Percutaneous endoscopic gastrostomy--to push or pull. A prospective randomized trial.

A prospective randomized study was undertaken to evaluate the Ponsky-Gauderer and Sachs-Vine types of gastrostomy kits. The techniques, complications, morbidity, and mortality with each type of device are compared. Both devices are found to compare favorably to the traditional surgically placed gastrostomy.

Impact of experience with a retrograde-viewing device on adenoma detection rates and withdrawal times during colonoscopy: the Third Eye Retroscope study group

BACKGROUND Colonoscopy has been adopted as the preferred method to screen for colorectal neoplasia in the United States. However, lesions can be missed because of numerous factors, including location on the proximal aspect of folds or flexures, where they may be difficult to detect with the forward-viewing colonoscope. The Third Eye Retroscope (TER) is a disposable device that is passed through the instrument channel of a standard colonoscope to provide a retrograde view that complements the forward view of the colonoscope during withdrawal. OBJECTIVE To evaluate whether experience with the TER affects polyp detection rates and procedure times in experienced endoscopists who had not previously used the equipment. DESIGN, SETTING, PATIENTS This was an open-label, prospective, multicenter study at 9 U.S. sites, involving 298 patients presenting for colonoscopy, evaluating the use of the TER in combination with a standard colonoscope. INTERVENTIONS After cecal intubation, the TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. MAIN OUTCOME MEASUREMENTS Primary outcome measures were the number and size of adenomas and all polyps detected with the standard colonoscope and with the colonoscope combined with the TER. Secondary outcome measures were withdrawal phase time and total procedure time. Each endoscopist examined 20 subjects, divided into quartiles according to the order of their procedures, and results were compared among quartiles. RESULTS Overall, 182 polyps were detected with the colonoscope and 27 additional polyps with the TER, a 14.8% increase (P < .001). A total of 100 adenomas were detected with the colonoscope and 16 more with the TER, a 16.0% increase (P < .001). For procedures performed after each endoscopist had completed 15 procedures while using the TER, the mean additional detection rates with the TER were 17.0% for all polyps (P < .001) and 25.0% for adenomas (P < .001). For lesions 6 mm or larger, the overall additional detection rates with the TER for all polyps and for adenomas were 23.2% and 24.3%, respectively. For lesions 10 mm or larger, the overall additional detection rates with the TER for all polyps and for adenomas were 22.6% and 19.0%, respectively. The mean withdrawal times in the first and fourth quartiles were 10.6 and 9.2 minutes, respectively (P = .044). LIMITATIONS There was no randomization or separate control group. The endoscopists judged whether each lesion could have been detected with the colonscope alone by using their standard technique. CONCLUSIONS Polyp detection rates improved significantly with the TER, especially after 15 procedures, when the mean additional detection rate for adenomas was 25.0%. Additional detection rates with the TER for medium-size and large adenomas were greater than for smaller lesions. These results suggest that, compared with a colonoscope alone, a retrograde-viewing device can increase detection rates for clinically significant adenomas without detriment to procedure time or procedure complications. ( CLINICAL TRIAL REGISTRATION NUMBER NCT00969124.).

Retrograde-viewing device improves adenoma detection rate in colonoscopies for surveillance and diagnostic workup

AIM To determine which patients might benefit most from retrograde viewing during colonoscopy through subset analysis of randomized, controlled trial data. METHODS The Third Eye® Retroscope® Randomized Clinical Evaluation (TERRACE) was a randomized, controlled, multicenter trial designed to evaluate the efficacy of a retrograde-viewing auxiliary imaging device that is used during colonoscopy to provide a second video image which allows viewing of areas on the proximal aspect of haustral folds and flexures that are difficult to see with the colonoscopes forward view. We performed a post-hoc analysis of the TERRACE data to determine whether certain subsets of the patient population would gain more benefit than others from use of the device. Subjects were patients scheduled for colonoscopy for screening, surveillance or diagnostic workup, and each underwent same-day tandem examinations with standard colonoscopy (SC) and Third Eye colonoscopy (TEC), randomized to SC followed by TEC or vice versa. RESULTS Indication for colonoscopy was screening in 176/345 subjects (51.0%), surveillance after previous polypectomy in 87 (25.2%) and diagnostic workup in 82 (23.8%). In 4 subjects no indication was specified. Previously reported overall results had shown a net additional adenoma detection rate (ADR) with TEC of 23.2% compared to SC. Relative risk (RR) of missing adenomas with SC vs TEC as the initial procedure was 1.92 (P = 0.029). Post-hoc subset analysis shows additional ADRs for TEC compared to SC were 4.4% for screening, 35.7% for surveillance, 55.4% for diagnostic and 40.7% for surveillance and diagnostic combined. The RR of missing adenomas with SC vs TEC was 1.11 (P = 0.815) for screening, 3.15 (P = 0.014) for surveillance, 8.64 (P = 0.039) for diagnostic and 3.34 (P = 0.003) for surveillance and diagnostic combined. Although a multivariate Poisson regression suggested gender as a possibly significant factor, subset analysis showed that the difference between genders was not statistically significant. Age, bowel prep quality and withdrawal time did not significantly affect the RR of missing adenomas with SC vs TEC. Mean sizes of adenomas detected with TEC and SC were similar at 0.59 cm and 0.56 cm, respectively (P = NS). CONCLUSION TEC allows detection of significantly more adenomas compared to SC in patients undergoing surveillance or diagnostic workup, but not in screening patients (ClinicalTrials.gov Identifier: NCT01044732).

M1359 Restore: Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction: A Double-Blind, Sham-Controlled Multicenter Study for Treatment of Inadequate Weight Loss or Weight Regain Following Roux-en-Y Gastric Bypass

Background and aims: Roux-en-Y gastric bypass technique (RYGBP) by inducing bacterial stasis could promote small intestinal bacterial overgrowth (SIBO). In a previous study performed in 146 patients with morbid obesity (1) we found an increase in the prevalence of SIBO compared to healthy subjects 17.1% vs.2.5% (p=0.03). The aim of this study was to evaluate prospectively the prevalence of SIBO in a larger population of patients withmorbid obesity, before and after bariatric surgery and its potential effect on vitamin deficiencies after surgery. Patients and methods: from October 2001 to July 2009, a glucose hydrogen (H2) breath test (BT, positive if fasting breath H2 concentration > 20 ppm and or increase > 10 ppm over baseline within the first 2 hours) was proposed to all obese patients referred for bariatric surgery (BMI > 40 kg/m 2 or > 35 in association with comorbidities) before and after bariatric surgery to assess the presence of SIBO. Vitamin levels (B12, B1, PP) were measured while vitamin supplementation was systematically prescribed after RYGBP. Results(mean ± SE, median (IQR) : 378 patients (336 women (88.9%), 39.6± 11.7 yrs, BMI : 45.7±6.3 kg/m 2 ) were included : 357 patients had a preoperative BT that was positive in 55 cases (15.4%), negative in 290 cases (81,2%) and doubtful or uninterpretable in 12 cases (3.4%). Twenty patients had BT after gastric banding [time since surgery 36 months (26-47), weight loss 22.9±14.1 kg] that was negative in 18 cases (90%) and positive in 2 cases (10%) (p = NS compared with preoperative situation). Sixty-five patients had a BT after RYGBP [time since surgery 9.2 months (6.8-23), weight loss 34.4± 11.5 kg] that was negative in 39 cases (60%) and positive in 26 cases (40%) (p<0.001 compared with preoperative situation). After RYGBP the percentage of patients with or without vitamin deficiencies was not different in patients with positive or negative BT (p = NS). Conclusion: in this study with a large number of patients, we confirm the presence of SIBO in 15% of patients with morbid obesity. After gastric banding, there is no increase in this prevalence while after RYGBP it increases to 40% of patients. In patients with systematic vitamin supplementation, a positive BT is not associated with an increase in the frequency of vitamin deficiencies. (1) Sabate et al. Obes Surg 2008 ; 18:371-377

White Paper AGA: Advanced Imaging in Barrett’s Esophagus

Enhanced imaging technologies such as narrow band imaging, flexible spectral imaging color enhancement, i-Scan, confocal laser endomicroscopy, and optical coherence tomography are readily available for use by endoscopists in routine clinical practice. In November 2014, the American Gastroenterological Associations Center for GI Innovation and Technology conducted a 2-day workshop to discuss endoscopic image enhancement technologies, focusing on their role in 2 specific clinical conditions (colon polyps and Barretts esophagus) and on issues relating to training and implementation of these technologies (white papers). Although the majority of the studies that use enhanced imaging technologies have been positive, these techniques ideally need to be validated in larger cohorts and in community centers. As it stands today, detailed endoscopic examination with high-definition white-light endoscopy and random 4-quadrant biopsy remains the standard of care. However, the workshop panelists agreed that in the hands of endoscopists who have met the preservation and incorporation of valuable endoscopic innovation thresholds (diagnostic accuracy) with enhanced imaging techniques (specific technologies), use of the technique in Barretts esophagus patients is appropriate.

CASE REPORT: Metastatic Carcinoid Tumor Discovered by Capsule Endoscopy and Not Detected by Esophagogastroduodenoscopy

Small bowel tumors are difficult to diagnose because of delayed presentation, nonspecific signs and symptoms, and lack of accurate diagnostic studies. The most common site for carcinoid tumors is the gastrointestinal tract (73.7%) (1). Within the gastrointestinal tract, most occur in the small intestine (28.7%), with the ileum being the most common site (15.4%) (1). Carcinoid tumors of the distal small bowel are aggressive and have usually metastasized by the time of diagnosis (2). Duodenal carcinoid tumors are uncommon and account for less than 5% of all carcinoids of the gastrointestinal tract in Western society, with the majority being located in the first portion of the duodenum (1, 2). For the most part, duodenal carcinoids are indolent, especially when less than 1 cm and localized to the submucosa (3). Features associated with metastatic risk are involvement of the muscularis propria, a size greater than 2 cm, and the presence of mitotic figures (3). Due to the rarity of small bowel tumors, no studies have been undertaken to determine the “gold standard” among various imaging techniques for diagnosis. However, it is felt that duodenal carcinoids will be identified more frequently with the increased use of upper endoscopy (2–4). The characteristic endoscopic finding of duodenal carcinoid tumors is a smooth, round elevation with an irregularly shaped erythematous depression or ulceration (5). Other diagnostic studies have significant limitations in their usefulness for localizing tumors in the small bowel. The routine small bowel follow-through is simple and non-

Management of Diminutive Colon Polyps Based on Endoluminal Imaging

Diminutive colon polyps, defined as 5 mm or less, are encountered increasingly at colonoscopy. The risk of serious pathology in such polyps is low. There is a risk and cost of resecting all such polyps and sending tissue for pathologic evaluation. Enhancement of endoluminal imaging may enable discrimination of neoplastic vs non-neoplastic polyps. If this discrimination can be performed accurately with high confidence, it may be possible to either resect and discard diminutive adenomas, or inspect and do-not-resect diminutive hyperplastic polyps. In 2011, an expert group recommended thresholds of 90% negative predictive value for adenomas, and 90% accuracy in predicting appropriate surveillance intervals. Since 2011, criteria for polyp discrimination have been published and validated by experts and nonexperts. In vivo studies have been performed to compare endoscopic impression and pathologic diagnosis. An expert panel was convened in late 2014 to review the literature to determine if the proposed thresholds for discrimination can be attained and to recommend the next steps for introducing changes in clinical practice. We conclude that threshold levels can be achieved with several endoscopic image enhancements. The next steps to implementation of practice change include acquiring data on training and competence, determining best practices for auditing performance, understanding patient education needs, and the potential cost benefit of such changes.

Capsule endoscopy for screening for short-segment Barrett's esophagus.

BACKGROUND:The rise in the incidence of esophageal adenocarcinoma has led to the development of new methods to screen for the precursor lesion, Barretts esophagus.AIM:To evaluate the potential role of esophageal capsule endoscopy in identifying the presence of short-segment Barretts esophagus.METHODS:Patients with biopsy-proven short-segment Barretts esophagus underwent esophageal capsule endoscopy. The images were reviewed by two expert observers with no knowledge of the purpose of the study. The data collected included transit time, quality of image, presence or absence of Z-line, Schatzkis ring, hiatal hernia, and Barretts esophagus (long or short, definite or suspected).RESULTS:Twenty patients were studied; in 18, the capsule passed into the stomach. Barretts esophagus was identified or suspected in eight cases (44%) by one observer and three (16%) by the second (P= 0.14). Although the Z-line was seen in the 18 cases that were qualified by both observers, there was an agreement in only six cases as to whether it was regular or irregular. Erosive gastroesophageal reflux disease (GERD) was scored as present in three and absent in six patients by both readers. Nonexisting feline esophagus, varices, and distal esophageal stricture were suspected in one patient each.CONCLUSIONS:Esophageal capsule endoscopy had a high interobserver variability and a low yield for short-segment Barretts esophagus. Esophageal capsule endoscopy cannot be recommended for screening for short-segment Barretts esophagus.