Sreenivasa S. Jonnalagadda

Incidence of Sedation-Related Complications With Propofol Use During Advanced Endoscopic Procedures

BACKGROUND & AIMS Propofol is an effective sedative in advanced endoscopy. However, the incidence of sedation-related complications is unclear. We sought to define the frequency of sedation-related adverse events, particularly the rate of airway modifications (AMs), with propofol use during advanced endoscopy. We also evaluated independent predictors of AMs. METHODS Patients undergoing sedation with propofol for advanced endoscopic procedures, including endoscopic retrograde cholangiopancreatography, endoscopic ultrasound, and small-bowel enteroscopy, were studied prospectively. Sedative dosing was determined by a certified registered nurse anesthetist with the goal of achieving deep sedation. Sedation-related complications included AMs, hypoxemia (pulse oximetry [SpO(2)] < 90%), hypotension requiring vasopressors, and early procedure termination. AMs were defined as chin lift, modified face mask ventilation, and nasal airway. We performed a regression analysis to compare characteristics of patients requiring AMs (AM+) with those who did not (AM-). RESULTS A total of 799 patients were enrolled over 7 months. Procedures included endoscopic ultrasound (423), endoscopic retrograde cholangiopancreatography (336), and small-bowel enteroscopy (40). A total of 87.2% of patients showed no response to endoscopic intubation. Hypoxemia occurred in 12.8%, hypotension in 0.5%, and premature termination in 0.6% of the patients. No patients required bag-mask ventilation or endotracheal intubation. There were 154 AMs performed in 115 (14.4%) patients, including chin lift (12.1%), modified face mask ventilation (3.6%), and nasal airway (3.5%). Body mass index, male sex, and American Society of Anesthesiologists class of 3 or higher were independent predictors of AMs. CONCLUSIONS Propofol can be used safely for advanced endoscopic procedures when administered by a trained professional. Independent predictors of AMs included male sex, American Society of Anesthesiologists class of 3 or higher, and increased body mass index.

ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies

The increasing global burden of obesity and its associated comorbidities has created an urgent need for additional treatment options to fight this pandemic. Endoscopic bariatric therapies (EBTs) provide an effective and minimally invasive treatment approach to obesity that would increase treatment options beyond surgery, medications, and lifestyle measures. This systematic review and meta-analysis were performed by the American Society for Gastrointestinal Endoscopy (ASGE) Bariatric Endoscopy Task Force comprising experts in the subject area and the ASGE Technology Committee Chair to specifically assess whether acceptable performance thresholds outlined by an ASGE Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document for clinical adoption of available EBTs have been met. After conducting a comprehensive search of several English-language databases, we performed direct meta-analyses by using random-effects models to assess whether the Orbera intragastric balloon (IGB) (Apollo Endosurgery, Austin, Tex) and the EndoBarrier duodenal-jejunal bypass sleeve (DJBS) (GI Dynamics, Lexington, Mass) have met the PIVI thresholds. The meta-analyses results indicate that the Orbera IGB meets the PIVI thresholds for both primary and nonprimary bridge obesity therapy. Based on a meta-analysis of 17 studies including 1683 patients, the percentage of excess weight loss (%EWL) with the Orbera IGB at 12 months was 25.44% (95% confidence interval [CI], 21.47%-29.41%) (random model) with a mean difference in %EWL over controls of 26.9% (95% CI, 15.66%-38.24%; P ≤ .01) in 3 randomized, controlled trials. Furthermore, the pooled percentage of total body weight loss (% TBWL) after Orbera IGB implantation was 12.3% (95% CI, 7.9%–16.73%), 13.16% (95% CI, 12.37%–13.95%), and 11.27% (95% CI, 8.17%–14.36%) at 3, 6, and 12 months after implantation, respectively, thus exceeding the PIVI threshold of 5% TBWL for nonprimary (bridge) obesity therapy. With the data available, the DJBS liner does appear to meet the %EWL PIVI threshold at 12 months, resulting in 35% EWL (95% CI, 24%-46%) but does not meet the 15% EWL over control required by the PIVI. We await review of the pivotal trial data on the efficacy and safety of this device. Data are insufficient to evaluate PIVI thresholds for any other EBT at this time. Both evaluated EBTs had ≤5% incidence of serious adverse events as set by the PIVI document to indicate acceptable safety profiles. Our task force consequently recognizes the Orbera IGB for meeting the PIVI criteria for the management of obesity. As additional data from the other EBTs become available, we will update our recommendations accordingly.

Comparison of white light and narrow band high definition images in predicting colon polyp histology, using standard colonoscopes without optical magnification.

BACKGROUND AND STUDY AIMS Narrow band imaging (NBI) with optical magnification is useful in predicting colon polyp histology. As magnifying endoscopes are not routinely available, we investigated the use of NBI and high definition white light imaging in determining polyp histology, using images obtained with colonoscopes without optical magnification. PATIENTS AND METHODS Images (white light and NBI) of colon polyps less than 10 mm in diameter were collected prospectively from patients undergoing screening colonoscopy and digitally stored. Two endoscopists later reviewed all images and predicted polyp histology as neoplastic or non-neoplastic using a modified Kudo classification. Comparison was made with histopathology. RESULTS Separate white light and NBI images of 80 polyps (49 neoplastic, 31 non-neoplastic) from 63 patients were recorded. Mean polyp size was 5.1 +/- 2.1 mm (5.4 +/- 2.2 neoplastic; 4.4 +/- 1.8 non-neoplastic; P = 0.02). In a pooled analysis, NBI correctly predicted neoplastic histology in 93 of 98 images (sensitivity 95 %, positive predictive value [PPV] 94 %) whereas white light did so in 58 of 98 images (sensitivity 59 %, PPV 79 %). NBI correctly predicted non-neoplastic histology in 56 of 62 images (specificity 90 %, negative predictive value [NPV] 92 %) whereas white light did so in 47 of 62 images (specificity 76 %, NPV 54 %). CONCLUSIONS NBI without optical magnification was more accurate in predicting colon polyp histology compared with white light imaging. Image quality and confidence in histology were significantly higher in the NBI group. NBI without optical magnification may be useful in predicting colon polyp histology.

Risk of post-ERCP pancreatitis with placement of self-expandable metallic stents

BACKGROUND There are conflicting data on the risk of post-ERCP pancreatitis (PEP) related to self-expandable metallic stents (SEMSs). OBJECTIVE To compare rates of PEP in patients who undergo biliary drainage with SEMSs or polyethylene stents (PSs). DESIGN Retrospective, cohort study. SETTING Tertiary-care medical center. PATIENTS This study involved patients undergoing ERCP for malignant biliary obstruction between January 2005 and October 2008. INTERVENTION First-time placement of a SEMS or PS for biliary decompression. MAIN OUTCOME MEASUREMENTS Early post-ERCP complications, particularly PEP. RESULTS We identified 544 eligible patients, 248 SEMSs (102 covered), and 296 PSs. The etiology of malignant biliary obstruction was similar between groups, with 55% from pancreatic cancer. The frequency of PEP was significantly higher in the SEMS group (7.3%) versus the PS group (1.3%) (OR 5.7 [95% CI, 1.9-17.1]). On univariate analysis, patient age of <40 years, a history of PEP, and at least 1 pancreatic duct injection were also significant predictors of PEP, whereas female sex and having pancreatic cancer were not. When significant variables were added to a multiple-predictor regression model, the odds of PEP from SEMS placement increased to 6.8 (95% CI, 2.2, 21.4). However, the frequency of PEP was similar between covered (6.9%) and uncovered (7.5%) SEMSs (OR 0.9 [CI, 0.3-2.4]). Purported SEMS-specific risk factors, including the use of cSEMSs, overlapping SEMSs, or having a biliary sphincterotomy were not found to be significant contributors to the higher risk. LIMITATIONS Retrospective design. CONCLUSION After we controlled for confounding variables, the frequency of PEP was significantly higher with placement of a SEMS compared with a PS. Rates of PEP were comparable with use of covered and uncovered SEMSs.

Stenting for malignant colonic obstruction: a comparison of efficacy and complications in colonic versus extracolonic malignancy

BACKGROUND Self-expandable metal stent placement for palliation of malignant colonic obstruction for colorectal cancer (CRC) is safe and efficacious. In contrast, outcomes of stent placement for extracolonic malignancy (ECM) are unclear. OBJECTIVE To compare the success and complication rates of colorectal stenting in patients with CRC versus those with ECM. DESIGN Retrospective chart review. SETTING Tertiary-care academic medical center. PATIENTS AND INTERVENTIONS Between September 2000 and December 2007, all patients with malignant colon obstruction in whom endoscopy was performed with the intention of placing a colonic metal stent. MAIN OUTCOME MEASUREMENTS Technical and clinical success rates, surgical interventions, and procedure-related complications. RESULTS Colonic stenting was performed for CRC in 34 patients and for ECM in 15 patients. Patients with CRC were more likely to have clinical success after all endoscopic therapy (94.1%) than those with ECM (20.0%) (P < .0001). Surgical diversion to relieve persistent obstructive symptoms was required in significantly more patients with ECM. Five patients with ECM (33.3%) had at least one complication, including 2 deaths, compared with 3 patients with CRC (8.8%) (P = .046). Only underlying ECM was predictive of failed colon stent placement by multivariate analysis (hazard ratio 21.0, P = .0013). A history of radiation therapy was the sole predictor of complications (hazard ratio 7.8, P = .048). LIMITATIONS Single institution, retrospective analysis, relatively small sample size. CONCLUSIONS Colon stenting for large-bowel obstruction from ECM is infrequently successful and is associated with a significantly higher risk of complications in comparison with patients with CRC.

Aspiration Therapy Leads to Weight Loss in Obese Subjects: A Pilot Study

BACKGROUND & AIMS Obese patients rarely achieve long-term weight loss with only lifestyle interventions. We evaluated the use of endoscopic aspiration therapy for obesity. Aspiration therapy involves endoscopic placement of a gastrostomy tube (A-Tube) and the AspireAssist siphon assembly (Aspire Bariatrics, King of Prussia, PA) to aspirate gastric contents 20 minutes after meal consumption. METHODS We performed a pilot study of 18 obese subjects who were randomly assigned (2:1) to groups that underwent aspiration therapy for 1 year plus lifestyle therapy (n = 11; mean body mass index, 42.6 ± 1.4 kg/m(2)) or lifestyle therapy only (n = 7; mean body mass index, 43.4 ± 2.0 kg/m(2)). Lifestyle intervention comprised a 15-session diet and behavioral education program. RESULTS Ten of the 11 subjects who underwent aspiration therapy and 4 of the 7 subjects who underwent lifestyle therapy completed the first year of the study. After 1 year, subjects in the aspiration therapy group lost 18.6% ± 2.3% of their body weight (49.0% ± 7.7% of excess weight loss [EWL]) and those in the lifestyle therapy group lost 5.9% ± 5.0% (14.9% ± 12.2% of EWL) (P < .04). Seven of the 10 subjects in the aspiration therapy group completed an additional year of therapy and maintained a 20.1% ± 3.5% body weight loss (54.6% ± 12.0% of EWL). There were no adverse effects of aspiration therapy on eating behavior and no evidence of compensation for aspirated calories with increased food intake. No episodes of binge eating in the aspiration therapy group or serious adverse were reported. CONCLUSIONS In a pilot study, aspiration therapy appears to be a safe and effective long-term weight loss therapy for obesity.

Accuracy of in vivo optical diagnosis of colon polyp histology by narrow-band imaging in predicting colonoscopy surveillance intervals

BACKGROUND The American Society for Gastrointestinal Endoscopy (ASGE) recently developed thresholds for the performance characteristics of technologies for real-time assessment of histology of diminutive (≤ 5 mm) colon polyps. Narrow-band imaging (NBI) has been shown to predict polyp histology with moderate to high accuracy in several studies. OBJECTIVE To determine whether in vivo optical diagnosis of polyp histology by using NBI can reach the 2 benchmarks set forth by the ASGE. DESIGN Retrospective analysis of data from 3 prospective clinical trials. SETTING Two tertiary referral centers. PATIENTS Subjects undergoing screening or surveillance colonoscopy. INTERVENTIONS In vivo optical diagnosis of polyp histology by using NBI. MAIN OUTCOME MEASUREMENT Accuracy in predicting colonoscopy surveillance intervals, negative predictive value (NPV) for diagnosing adenomatous histology in the rectosigmoid. RESULTS A total of 410 patients met the inclusion/exclusion criteria and had at least 1 polyp seen and resected during colonoscopy. Using in vivo optical diagnosis instead of histopathology for all diminutive polyps predicted the correct colonoscopy surveillance interval in 86% to 94% patients. When optical diagnosis was limited to diminutive polyps in the rectosigmoid only, the NPV for diagnosing adenomatous histology with NBI was 95%. LIMITATIONS Retrospective analysis from tertiary referral centers. CONCLUSIONS The threshold NPV for diagnosing adenomatous histology in diminutive rectosigmoid polyps recently set forth by the ASGE can be achieved by using NBI. The threshold accuracy rate for predicting surveillance interval recommendations can be reached by using NBI, but only if patients with 1 to 2 small adenomas without advanced features have a repeat colonoscopy in 10 years.

Reliability of gross visual assessment of specimen adequacy during EUS-guided FNA of pancreatic masses

BACKGROUND In many centers, on-site cytopathologists are not available during EUS-guided FNA (EUS-FNA) examinations. Often, endosonographers request that technologists assess the adequacy of FNA by gross inspection of the slides. To date, there has not been a study that assessed the accuracy of experienced technologists in predicting tissue sampling adequacy by gross inspection before cytologic staining. OBJECTIVES To assess a grading system used by cytotechnologists and EUS technologists during gross inspection of FNA slides in reliably predicting specimen adequacy compared with the final cytologic diagnoses. DESIGN Prospective, double-blind, controlled study. SETTING Academic tertiary-referral center with a high-volume EUS practice. PATIENTS Fifty-one patients with a suspected solid pancreatic mass who were undergoing planned EUS-FNA. MAIN OUTCOME MEASUREMENTS The degree of correlation in the assessment of specimen adequacy as exhibited by a weighted kappa statistic between 2 groups of technologists and a board-certified cytopathologist. RESULTS FNA was performed in 37 cases with 234 individual slide specimens available for analysis. Only fair agreement was observed between cytotechnologists and EUS technologists versus final cytopathologic assessment of adequacy (kappa 0.20 and 0.19, respectively). The routine practice of 6 to 7 FNA passes yielded adequate tissue for assessment in 36 of 37 patients (97%). LIMITATIONS Interobserver variability, single center, and findings applicable only to solid pancreatic lesions. CONCLUSIONS Neither trained EUS technologists nor cytotechnologists were able to provide a reliable assessment of pancreatic-mass FNA adequacy by using gross visual inspection of the specimen on a slide. Rapid on-site cytopathology reduced the number of passes, ensured specimen adequacy, provided definitive diagnosis, and should be used in centers where available.

Obesity as a risk factor for sedation-related complications during propofol-mediated sedation for advanced endoscopic procedures

BACKGROUND There are limited data on the safety of anesthesia-assisted endoscopy by using propofol-mediated sedation in obese individuals undergoing advanced endoscopic procedures (AEPs). OBJECTIVE To study the association between obesity (as measured by body mass index [BMI]) and the frequency of sedation-related complications (SRCs) in patients undergoing AEPs. DESIGN Prospective cohort study. SETTING Tertiary referral center. PATIENTS A total of 1016 consecutive patients undergoing AEPs (BMI <30, 730 [72%]; 30-35, 159 [16%]; >35, 127 [12%]). INTERVENTION Monitored anesthesia sedation with propofol alone or in combination with benzodiazepines and/or opioids. MAIN OUTCOME MEASUREMENTS SRCs, airway maneuvers (AMs), hypoxemia, hypotension requiring vasopressors, and early procedure termination were compared across 3 groups. RESULTS There were 203 AMs in 13.9% of patients, hypoxemia in 7.3%, need for vasopressors in 0.8%, and premature termination in 0.6% of patients. Increasing BMI was associated with an increased frequency of AMs (BMI <30, 10.5%; 30-35, 18.9%; >35-26.8%; P < .001) and hypoxemia (BMI <30, 5.3%; 30-35, 9.4%; >35, 13.4%; P = .001); there was no difference in the frequency of need for vasopressors (P = .254) and premature termination of procedures (P = .401). On multivariable analysis, BMI (odds ratio [OR] 2.0; 95% CI, 1.3-3.1), age (OR 1.1; 95% CI, 1.0-1.1), and American Society of Anesthesiologists class 3 or higher (OR 2.4; 95% CI, 1.1-5.0) were independent predictors of SRCs. In obese individuals (n = 286), there was no difference in the frequency of SRCs in patients receiving propofol alone or in combination (P = .48). LIMITATIONS Single tertiary center study. CONCLUSIONS Although obesity was associated with an increased frequency of SRCs, propofol sedation can be used safely in obese patients undergoing AEPs when administered by trained professionals.

Endoscopic bariatric therapies

The ASGE Technology Committee provides reviews of its associated comorbid conditions including hypertenexisting, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used, performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported adverse events of a given technology. Both are supplemented by accessing the “related articles” feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but in many cases, data from randomized, controlled trials are lacking. In such cases, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors. This Technology Status Evaluation Report is drafted by 1 comember of the ASGE Technology Committee and the Bariatric Endoscopy Task Force (B.K.A.D.). It was reviewed and edited by the entire ASGE Bariatric Endoscopy Task Force and the Chair of the ASGE Technology Committee and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through December 2014 for relevant articles by using the key words “bariatric,” “endoscopic,” “intragastric balloon,” “bypass sleeve,” “gastroplasty,” and “aspiration therapy.” Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.