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The X-Tack endoscopic HeliX tacking system (Apollo Endosurgery, Austin, Tex, USA) has recently been approved by the Food and Drug Administration and is slowly gaining popularity for the closure of large tissue defects. Despite its increasing use, outcome data of using the X-Tack system for mucosal defect closure after endoscopic resection (ER) are limited. Here, we report the follow-up outcomes of a series of cases that underwent ER and mucosal closure aided by the HeliX tacking system.We identified a total of 5 cases in which the X-Tack system and endoclips were used for mucosal defect closure after ER. The cases involved ER of large and/or flat polyps in the duodenum and colon. The patients were followed up at 4, 6, and 9 months after ER.In all cases, X-Tacks with endoclips achieved complete closure of the large mucosal defects. None of the patients experienced any adverse events, such as abdominal pain or bleeding. At follow-up, the X-Tacks either fell off or were seen grouped or situated as a single piece (tack) in the mucosa where initially placed. None of the endoclips were found during the follow-up endoscopic examinations.The X-Tack system together with endoclips facilitated complete closure of large mucosal defects, especially for lesions located in difficult locations. At follow-up, several retained X-Tacks were found either in groups or as a single piece. The X-Tacks seen in groups will likely fall off with repetitive pulling forces with food or feces. However, the single tacks that were secured in the wall may stay indefinitely. The novel HeliX tacking system seems to be a promising aid for the effective closure of large mucosal defects; however, further studies are needed to assess the long-term outcome of this novel system.

Video 1EUS-guided choledochoduodenostomy using a lumen-apposing metal stent in a patient with preexisting duodenal stent and ascites.

Background and Aims Closure of endoscopic resection defects can be achieved with through-the-scope clips, over-the-scope clips or endoscopic suturing. However, these devices are often limited by their inability to close large, irregular, and difficult to reach defects. Thus, we aimed to assess the feasibility and safety of the novel through-the-scope suture-based closure system that was developed to overcome these limitations. Methods This is a retrospective multicenter study involving 8 centers in the United States. Primary outcomes included feasibility and safety of early use of the device. Secondary outcomes included assessment of need for additional closure devices, prolonged procedure time, and technical feasibility of performing the procedure with an alternative device(s). Results A total of 93 patients (48.4% female) with mean age 63.6 ± 13.1 years were included. Technical success was achieved in 83 patients (89.2%) and supplemental closure was required in 24.7% (n=23) of patients with a mean defect size of 41.6 ± 19.4 mm. Closure with an alternative device was determined to be impossible in 24.7% of patients due to location, size, or shape of the defect. The use of the tack and suture device prolonged the procedure in 8.6% of the cases but was considered acceptable. Adverse events occurred in 2 patients (2.2%) over a duration of follow-up of 34 days (interquartile range: 13-93.5 days) and were mild and moderate in severity. No serious adverse events or procedure-related deaths occurred. Conclusions The novel endoscopic through-the-scope tack and suture system is safe, efficient, and permits closure of large, and irregularly shaped defects that were not possible with predicate devices.

The outcomes of endoscopic submucosal dissection (ESD) for T1b esophageal cancer (EC) and its recurrence rates remain unclear in the West. Using a multicenter cohort, we evaluated technical outcomes and recurrence rates of ESD in the treatment of pathologically staged T1b EC.We included patients who underwent ESD of T1b EC at 7 academic tertiary referral centers in the United States (n = 6) and Brazil (n = 1). We analyzed demographic, procedural, and histopathologic characteristics and follow-up data. Time-to-event analysis was performed to evaluate recurrence rates.Sixty-six patients with pathologically staged T1b EC after ESD were included in the study. A preprocedure staging EUS was available in 54 patients and was Tis/T1a in 27 patients (50%) and T1b in 27 patients (50%). En-bloc resection rate was 92.4% (61/66) and R0 resection rate was 54.5% (36/66). Forty-nine of 66 patients (74.2%) did not undergo surgery immediately after resection and went on to surveillance. Ten patients had ESD resection within the curative criteria, and no recurrences were seen in a 13-month (range, 3-18.5) follow-up period in these patients. Ten of 39 patients (25.6%) with noncurative resections had residual/recurrent disease. Of the 10 patients with noncurative resection, local recurrence alone was seen in 5 patients (12.8%) and metastatic recurrence in 5 patients (12.8%). On univariate analysis, R1 resection had a higher risk of recurrent disease (hazard ratio, 6.25; 95% confidence interval, 1.29-30.36; P = .023).EUS staging of T1b EC has poor accuracy, and a staging ESD should be considered in these patients. ESD R0 resection rates were low in T1b EC, and R1 resection was associated with recurrent disease. Patients with noncurative ESD resection of T1b EC who cannot undergo surgery should be surveyed closely, because recurrent disease was seen in 25% of these patients.

Peroral endoscopic myotomy (POEM) is a novel clinical technique developed in Japan used to treat esophageal achalasia and esophageal motility disorders. This technique has been rapidly accepted and widely disseminated throughout our clinical practice because of its low invasiveness, technical novelty, and high efficacy. Since the advent of POEM, there have been no clinical guidelines that clearly indicated its standard of care, and these guidelines have been anticipated both nationally and internationally by clinicians who engage in POEM practice. In 2017, to meet these needs, the Japan Gastroenterological Endoscopy Society (JGES) launched the guideline committee for POEM. Based on the guideline development process proposed by the Medical Information Network Distribution Service (MINDS), the guideline committee initially created research questions on POEM and conducted a systematic review and meta-analysis on each topic. The clinical research extracted from databases for these clinical questions and the systematic review mainly comprised a few retrospective studies with a small number of participants and short trial periods; hence, the strength of the evidence and recommendations derived from these results was low. Throughout this process, the guideline committee met thrice: once on May 13, 2017, and again on September 17, 2017, to formulate the draft. A consensus meeting was then held on January 14, 2018, in Tokyo to establish the guideline statements and finalize the recommendations using the modified Delphi method. This manuscript presents clinical guidelines regarding current standards of practice and recommendations in terms of the nine chief topics in POEM.

Background and Aims The role of per-oral pancreatoscopy (POP) in the evaluation of occult pancreatic duct (PD) lesions remains limited to case series. The aim of this study was to evaluate the ability of POP to differentiate malignant from benign diseases of the PD. Methods Patients who underwent POP between 2000 and 2013 for the evaluation of indeterminate PD strictures, dilatations, or with suspected or known main duct intraductal papillary mucinous neoplasm were identified. Main outcome measurements were visual impression accuracy, POP tissue sampling, efficacy, and safety of POP. Results During the study period, 79 patients who underwent POP for the evaluation of pancreatic stricture or dilatation were identified. Technical success was achieved in 78 (97%). In the PD neoplasia group (n = 33), the final diagnosis was based on index confirmatory POP-guided tissue sampling in 29 (88%). For the detection of PD neoplasia, POP visual impression had a sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 87%, 86%, 83%, 91%, and 87%, respectively. When combined with POP-guided tissue sampling, the values were 91%, 95%, 94%, 93%, and 94%, respectively. Of 102 POPs performed, adverse events were noted in 12 (12%) cases. Conclusions This study demonstrates a high technical success rate, visual impression accuracy, and tissue sampling capability of POP. Examinations were performed by endoscopists with expertise in pancreatoscopy interpretation, and the results may not be generalizable.

The exact cutoff value at which pancreatic cyst fluid carcinoembryonic antigen (CEA) level distinguishes pancreatic mucinous cystic neoplasms (MCNs) from pancreatic nonmucinous cystic neoplasms (NMCNs) is unclear. The aim of this multicenter retrospective study was to evaluate the diagnostic accuracy of cyst fluid CEA levels in differentiating between MCNs and NMCNs.Consecutive patients who underwent EUS with FNA at 3 tertiary care centers were identified. Patients with histologic confirmation of cyst type based on surgical specimens served as the criterion standard for this analysis. Demographic characteristics, EUS morphology, FNA fluid, and cytology results were recorded. Multivariate logistic regression analysis to identify predictors of MCNs was performed. Receiver-operating characteristic (ROC) curves were generated for CEA levels.A total of 226 patients underwent surgery (mean age, 61 years, 96% white patients, 39% female patients) of whom 88% underwent Whipple's procedure or distal pancreatectomy. Based on surgical histopathology, there were 150 MCNs and 76 NMCNs cases. The median CEA level was 165 ng/mL. The area under the ROC curve for CEA levels in differentiating between MCNs and NMCNs was 0.77 (95% confidence interval, 0.71-0.84, P.01) with a cutoff of 105 ng/mL, demonstrating a sensitivity and specificity of 70% and 63%, respectively. The cutoff value of 192 ng/mL yielded a sensitivity of 61% and a specificity of 77% and would misdiagnose 39% of MCN cases.Cyst fluid CEA levels have a clinically suboptimal accuracy level in differentiating MCNs from NMCNs. Future studies should focus on novel cyst fluid markers to improve risk stratification of pancreatic cystic neoplasms.

Background and Aims Cholangiopancreatoscopy for evaluating pancreaticobiliary pathology is currently limited by suboptimal optics. The aim of this study was to characterize the operating characteristics of per-oral video cholangiopancreatoscopy with narrow-band imaging (POVCP) findings in indeterminate pancreaticobiliary disease and to describe their association with neoplasia. Methods Data from consecutive patients undergoing POVCP for the evaluation of indeterminate pancreaticobiliary disease at a single tertiary care center were analyzed. Two experienced investigators had previously agreed on POVCP findings and terminology that were documented in endoscopy reports. Endoscopic procedural data from POVCPs performed between January 2006 and April 2015 and clinical data were abstracted from the endoscopic database and electronic medical records. Study endpoints included tissue-proven neoplasia or benign disease with ≥1 year of follow-up. Results A total of 109 patients were identified; 13 were excluded because of the presence of stone disease, known pancreaticobiliary malignancy, or presumed benign disease with ≤1 year of follow-up. Most patients (85%) underwent POVCP for biliary disease and 15% underwent POVCP for a pancreatic cause. Tortuous and dilated vessels ( P P P = .003), and the presence of fish-egg lesions ( P = .04) were found to be significantly associated with neoplasia. The overall POVCP impression had a high sensitivity (85%) and negative predictive value (89%) in assessing for the presence of neoplasia. Conclusions Per-oral video cholangiopancreatoscopy is effective in the evaluation of indeterminate pancreaticobiliary disease. Tortuous and dilated vessels, infiltrative stricture, polypoid mass, and the presence of fish-egg lesions are significantly associated with neoplasia.

Aim: The aim of this study is to introduce recent progress in the treatment of pancreatic pseudocyst, abscess and necrosis using the endoscopic approach. Methods: Studies on PubMed and MEDLINE from the last 30 years on progress in the management of the complications from severe pancreatitis were researched and reviewed. Herein, the indication for intervention, definition of fluid collection associated with acute pancreatitis and treatment modalities of these complications are summarized. Results: Three types of management are employed for complications of severe pancreatitis: the endoscopic, surgical and percutaneous approaches. Conclusions: Over the years, as technical expertise has increased and instruments for endoscopy have improved, patients who had endoscopic surgery to address the complications of severe pancreatitis have had higher survival rates, lower mortality rates and lower complication rates than those having open debridement. However, traditional open abdominal surgery should be advocated when minimally invasive management fails or necrosis is extensive and extends diffusely to areas such as the paracolic gutter and the groin (i.e. locations not accessible by endoscopy).

Summary Endoscopic complications are rare but inevitable, occurring in fewer than 0.35% of procedures [B]. Knowledge of potential complications and their expected frequency can lead to an improved informed consent process [C]. Complications from the procedure include perforation, hemorrhage, postpolypectomy coagulation syndrome, infection, preparation-associated complications, and death, and are more likely to occur with therapeutic procedures rather than diagnostic procedures [B]. Risk factors for poylpectomy-associated complications include the location and size of the polyp, experience of the operator, polypectomy technique and possibly the type of electrocoagulation current used [B]. Use of saline solution injection under large sessile polyps decreases depth of thermal injury [A] and may decrease complications [B]. Early recognition of complications and prompt intervention may decrease patient morbidity [C]. Treatment of complications range from supportive for postpolypectomy coagulation syndrome, to repeat colonoscopy with injection or electrocoagulation for bleeding, to surgical repair for free perforation [B]. Consideration of the risks and benefits may improve clinical outcome by identifying potential complications and taking appropriate steps to minimize the risks [C].

Background Comparative data regarding complications associated with ERCP alone or when performed with cholangiopancreatoscopy (CP) are lacking. Objective To determine whether ERCP complications are more frequent when concomitant CP is performed. Design A retrospective query of a prospectively maintained database of ERCP, CP, and complications. Main Outcome Measurements Consensus criteria complications and additional adverse events (AEs), including unplanned medical evaluation, cardiopulmonary/sedation events, and others. Setting Academic, tertiary referral center. Results A total of 4214 ERCPs were performed (337 sphincter of Oddi manometry cases excluded) during the study period, of which 3475 ERCPs and 402 ERCPs with CP were analyzed. There were 28 of 402 AEs (7.0%) in the ERCP with CP group and 101 of 3475 (2.9%) in the ERCP-only group (odds ratio [OR], 2.50; 95% CI, 1.56-3.89). Subgroup analysis revealed a significantly higher rate of cholangitis in the CP group versus ERCP group (1.0% vs 0.2%; OR, 4.98; 95% CI, 1.06-19.67) and similar rates of pancreatitis (2.2% vs 1.3%; OR, 1.75; 95% CI, 0.74-3.65) and perforation (1.0% vs 0.3%; OR, 3.16; 95% CI, 0.73-10.75). Limitations Retrospective review of a complications database that relies on physician self-reporting. Conclusions AEs from CP may be more than double those of ERCP alone (when sphincter of Oddi manometry cases are excluded). CP appears to be associated with a significantly higher rate of cholangitis, possibly because of intermittent intraductal irrigation required during the procedure.

This is one of a series of statements discussing the use of GI endoscopy in common clinical situations. The Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy (ASGE) prepared this text. In preparing this guideline, a search of the medical literature was performed by using PubMed. Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants. When few or no data exist from well-designed prospective trials, emphasis is placed on results from large series and reports from recognized experts. Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus at the time the guidelines are drafted. Further controlled clinical studies may be needed to clarify aspects of this guideline. This guideline may be revised as necessary to account for changes in technology, new data, or other aspects of clinical practice. The recommendations are based on reviewed studies and are graded on the quality of the supporting evidence (Table 1). The strength of individual recommendations is based on both the aggregate evidence quality and an assessment of the anticipated benefits and harms. Weaker recommendations are indicated by phrases such as "we suggest," whereas stronger recommendations are typically stated as "we recommend." This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients. This guideline is not a rule and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment. Clinical decisions in any particular case involve a complex analysis of the patient's condition and available courses of action. Therefore, clinical considerations may lead an endoscopist to take a course of action that varies from this guideline.

Background When conventional ERCP methods fail because of periampullary or ductal obstruction, EUS-guided cholangiopancreatography (EUS-CP) may aid in pancreaticobiliary access. Objective To report our experience when using single-operator EUS-CP. Setting An academic tertiary-referral center. Methods Consecutive patients undergoing EUS-CP were prospectively identified. These patients had undergone failed attempt(s) at therapeutic ERCP. A data sheet was used to record indications, reasons for failed ERCP, EUS-CP visualization of the duct of interest, transpapillary or transenteric intervention, clinical follow-up, and complications. Main Outcome Measurements Technical success was decompression of the duct of interest. Clinical success was resolution of jaundice or a ≥50% reduction in pain or narcotics, as applicable. Results Between February 2003 and June 2007, EUS-CP was attempted in 20 patients (11 men, 9 women; mean [SD] age 58 ± 14.9 years). Indications included jaundice (n = 8), biliary stones (n = 3), chronic pancreatitis (n = 6), acute pancreatitis (n = 2), and papillary stenosis (n = 1). Reasons for failed ERCP included periampullary mass (n = 8), intradiverticular papillae (n = 4), and pancreatic duct (PD) stricture (n = 7) or stone (n = 1). Technical success was achieved in 18 of 20 patients (90%). Biliary decompression was obtained in 11 of 12 patients (92%) (7 transpapillary and 4 transenteric-transcholedochal). Pancreatic decompression was obtained in 7 of 8 patients (88%) (3 transpapillary, 4 transgastric). On follow-up, clinical improvement was noted in 15 of 20 patients (70%). For treatment of pain associated with chronic pancreatitis, pain scores decreased by a mean of 1.75 ( P = .18). Complications (in 2 of 20 [10%]) included perforation (n = 1) and respiratory failure (n = 1). Limitations A single-center nonrandomized observational study with a small patient population. Conclusions At our academic referral center, single-operator EUS-CP provided decompression of obstructed ducts and may be performed after a failed attempt at conventional ERCP during the same endoscopic session.

Background The colonic pit pattern is recognized as an aid to the differential diagnosis between hyperplastic lesions, adenoma, and carcinoma, and is a focus for observation by magnification chromoendoscopy, especially in Japan. This study evaluated intra- and interobserver agreement of experienced endoscopists in the assessment of colonic pit patterns when using the Kudo classification. Methods A total of 220 magnification chromoendoscopic pictures of colonic lesions were selected, of which 215 were collected from a consecutive series of patients. The pictures were randomly displayed twice to 6 experienced endoscopists at an interval of 1 week. Each picture was assessed for predominant pit pattern by using the classification of Kudo. Histopathologic diagnosis also was predicted based on the pit pattern diagnosis. Kappa statistics were used to estimate intra- and interobserver variation. Results The mean (standard deviation) inter- and intra-observer kappa values for experienced endoscopists were 0.716 (0.031) and 0.810 (0.084), respectively. For prediction of histopathology according to the pit pattern diagnosis, the mean (standard deviation) inter- and intra-observer kappa values were 0.776 (0.032) ( p =0.001) and 0.862 (0.069) ( p =0.028), respectively. Conclusions For experienced endoscopists, the inter- and intra-observer reproducibility of the classification of colonic pit pattern is good.

The occurrence of superficial carcinoma over a benign tumor of the esophagus is considered to be rare. Only a few reports have been reported and all of them were treated surgically. We now report one case of superficial carcinoma overlying an esophageal lipoma that was successfully resected endoscopically. The patient was a 61-year-old man who had no symptoms. A submucosal tumor was found at the thoracic esophagus by upper gastrointestinal endoscopy. The top of the tumor was slightly depressed with mild redness and its surface was irregular. This depressed lesion was not stained by iodine. Histological examination of endoscopic biopsy revealed squamous cell carcinoma. To completely remove this tumor in a single fragment, we used an insulation-tipped electrosurgical knife. An en bloc resection of the tumor was completed without complications.