PROSPECTIVE, RANDOMIZED CONTROLLED STUDY EVALUATING DOUBLE BALLOON INTERVENTIONAL ENDOSCOPIC PLATFORM FOR COLORECTAL ESD.

BACKGROUNDS & AIMS: Endoscopic submucosal dissection (ESD) can be challenging/time-consuming. A Double Balloon Interventional Platform (DBIP) was designed to assist with navigation, stabilization, traction and device delivery during complex colorectal polypectomy. STUDY AIM: to compare traditional (T-ESD) to DBIP-assisted ESD (DBIP-ESD) in a prospective, randomized trial. METHODS: Patients with colorectal polyps ≥ 2 cm were randomly assigned (1:1) to DBIP-ESD or T-ESD. Primary study endpoint: mean total procedure time difference between groups. Secondary endpoints: intra-procedural time-points, en bloc resection rate, procedure cost, adverse events, and 3-month assessment. A sample size of 200 subjects for ≥ 80% power was calculated. Interim analysis for early study termination was planned at 70% enrolment if primary endpoint was met (p ≤ 0.05). RESULTS: 147 patients were enrolled between February 2019-February 2020. Seven patients dropped out. Interim analysis was performed on 140 patients (71 DBIP-ESD, 69 T-ESD). Demographics, co-morbidities, lesion size/location/classification were similar between groups. Mean procedure time decreased with DBIP (88.6±42.7 min) vs. T-ESD (139.5±83.2 min), [51 minutes, 36.5%, p<0.001], with procedural savings of $760.16 (14%) per patient after DBIP cost. DBIP increased dissection speed by 49.0% (15.1±8.0 vs 7.7±6.6 cm2/hour, p< 0.001). En bloc resection was superior with DBIP (97.2% vs 87.0%, p=0.030). Mean navigation time with DBIP for sutured defect closure decreased by 7.7 minutes (p<0.001). There were no adverse events in the DBIP group. CONCLUSIONS: DBIP decreased total procedure time, improved en bloc resection rate, facilitated sutured defect closure, making DBIP a promising and cost-effective tool to improve colorectal ESD adoption.

Conventional Versus Traction Endoscopic Submucosal Dissection for Colorectal Tumors: A Meta-analysis of Randomized Controlled Trials.

INTRODUCTION: Compared with conventional endoscopic submucosal dissection (C-ESD) for colorectal lesions, the traction method (T-ESD) allows the lesion to be stabilized with easier dissection. However, randomized controlled trials (RCTs) have reported conflicting results on the clinical outcomes of T-ESD as compared with C-ESD. We conducted a meta-analysis to compile the data. METHODS: Multiple databases were searched for RCTs evaluating C-ESD versus T-ESD for colorectal tumors. The end points of interest were procedure time (min), resection speed (mm²/min), R0 resection, en bloc resection, delayed bleeding, and perforation. Standard meta-analysis methods were employed using the random-effects model. RESULTS: Six RCTs with a total of 566 patients (C-ESD n=284, T-ESD n=282) were included. The mean age was 67±10 y and 60% were men. As compared with the T-ESD technique, the C-ESD group was associated with longer procedure time (SMD 0.91, 95% CI 0.58 to 1.23, P<0.00001) and lesser resection speed (SMD -1.03, 95% CI -2.01 to -0.06, P=0.04). No significant difference was found in the 2 groups with respect to R0 resection rate (RR 1.00, 95% CI 0.94 to 1.06, P=0.87), en bloc resection (RR 0.99, 95% CI 0.97 to 1.01, P=0.35), delayed bleeding (RR 0.66, 95% CI 0.17 to 2.59, P=0.55) and perforation (RR 2.16, 95% CI 0.75 to 6.27, P=0.16). DISCUSSION: On meta-analysis, pooled procedure time was significantly faster with T-ESD compared with C-ESD. The clinical outcomes, however, were comparable.

Accuracy and Inter-observer Agreement Among Endoscopists for Visual Identification of Colorectal Polyps Using Endoscopy Images.

BACKGROUND: It is essential to accurately distinguish small benign hyperplastic colon polyps (HP) from sessile serrated lesions (SSL) or adenomatous polyps (TA) based on endoscopic appearances. Our objective was to determine the accuracy and inter-observer agreements for the endoscopic diagnosis of small polyps. METHODS: High-quality endoscopic images of 30 small HPs, SSLs, and TAs were used randomly to create two-timed PowerPoint slide sets-one with and another one without information on polyp size and location. Seven endoscopists viewed the slides on two separate occasions 90 days apart, identified the polyp type, and graded their confidence level. Overall and polyp-specific accuracies were assessed for the group and individual endoscopists. Chi-square tests and Kappa (κ) statistics were used to compare differences as appropriate. RESULTS: When polyp size and location were provided, overall accuracy was 67.1% for TAs, 50.0% for SSLs, and 41.4% for HPs; the corresponding accuracies were 60%, 44.3%, and 34.3% when polyp size and location were withheld (p < .001). Inter-observer agreement was moderate for TAs (κ = 0.50) and fair for SSLs (κ = 0.26) and HPs (κ = 0.29); the corresponding inter-observer agreements were 0.44, 0.31, and 0.17 with polyp size and location withheld. Accuracy was not affected by knowledge of polyp size, location, or confidence level. Endoscopists with ≥ 10 years (vs. < 10 years) of colonoscopy experience had marginally higher (56% vs. 40%, p = 0.05) accuracy for SSL diagnosis. CONCLUSIONS: The ability to distinguish between small TAs, SSLs, and HPs on their endoscopic appearance is poor regardless of the endoscopists' knowledge of polyp size and location.

Variceal ligation in decompensated cirrhosis before esophageal endoscopic submucosal dissection.

Video 1This video details our case as well as our method for successfully eradicating varices immediately prior to esophageal endoscopic submucosal dissection to minimize risks of variceal hemorrhage.

Purely endoscopic appendectomy.

Video 1Submucosal nodule in the cecum. After submucosal injection, a circumferential incision of the mucosa surrounding the lesion is performed with DualKnife (Olympus America, Center Valley, Pa, USA). The fore-balloon of the double-balloon endoluminal interventional platform (DBEIP) is deployed and the edges of the circumferential incision are attached with 2 endoscopic clips to the long suture-loop mounted on the fore-balloon of the DBEIP. The fore-balloon is retracted in anal direction, pulling the lesion into the cecum. Careful endoscopic submucosal dissection is performed with DualKnife and HookKnife (Olympus America). Dissection is markedly facilitated by traction and continued until the entire appendix is pulled into the cecum. The tip of the appendix is separated from surrounding tissues, resulting in a full-thickness cecal wall defect. The suture-loop holding the resected appendix is cut with LoopCutter (Olympus America). The resected appendix is removed through DBEIP and the Overstitch endoscopic suturing device (Apollo Endosurgery, Austin, Tex, USA) is advanced into the cecum. The full-thickness defect in the cecal wall is completely closed with 2 continuous sutures. The final view demonstrates the entire resected appendix.

Endoscopy-Induced Pancreatic Pseudocyst Rupture: A Case of Secondary Peritonitis After Upper Endoscopy.

Pancreatic pseudocysts are often drained endoscopically after 4-6 weeks of maturation. Allowing for developed encapsulation ensures that the cyst walls are strong enough to sustain drainage. However, in 3%-5% of these cases, pseudocysts will rupture spontaneously and put patients at risk of peritonitis. We present the first documented case of pancreatic pseudocyst rupture after upper endoscopy. Exploratory laparotomy confirmed the absence of viscus perforation and highlighted the danger of any procedure that increases intra-abdominal pressure in a patient with a pancreatic pseudocyst. Awareness of this complication should impact our decision when considering endoscopy in patients with pancreatic pseudocysts.

The Development of the Overstitch System and Its Potentials.

Endoscopic suturing device for flexible endoscopy was conceptualized by Apollo Group in collaboration with Olympus Optical Ltd. The first modification of suturing device for flexible endoscopy (Eagle Claw) was manufactured by Olympus engineers and extensively used by members of Apollo Group in numerous bench-top experiments on isolated pig stomachs and in live porcine model. The suturing system for flexible endoscopy in humans (Overstitch) was cleared for general clinical use in the United States in 2008. The latest model is compatible with more than 20 single-channel flexible endoscopes with diameters ranging from 8.8 mm to 9.8 mm made by major endoscope manufacturers.

Poor Survival After Retransplantation in NASH Cirrhosis.

BACKGROUND: Nonalcoholic steatohepatitis (NASH) cirrhosis is a common indication for liver transplantation (LT) in the United States. There is a paucity of data on retransplantation (re-LT) in those who were initially transplanted for NASH. METHODS: We queried the United Network for Organ Sharing data sets from 2002 to 2016 to analyze the outcomes of adults with NASH (n = 128) and compared them with groups that received re-LT for cryptogenic cirrhosis (n = 189), alcoholic cirrhosis (n = 300) or autoimmune hepatitis cirrhosis (n = 118) after excluding multiple-organ re-LT and individuals with hepatocellular carcinoma. We estimated survival probabilities using a Kaplan-Meier estimator, and a relative risk of patient and graft mortality using proportional hazards regression. RESULTS: The NASH group was older and had a higher prevalence of obesity, type II diabetes mellitus, renal insufficiency, portal vein thrombosis, and poor performance status. The median interval between the first and the second LT was shorter in the NASH group (27 days). The graft and patient 5-year survival rates were lower for the NASH group after re-LT compared with the other 3 groups. After adjusting for demographic and disease complication factors, the factors that increased a risk of patient or graft failure were a poor performance status (hazard ratio [HR], 1.64; 1.19-2.26), Donor Risk Index (HR, 1.51; 1.08-2.12), and a high Model for End-stage Liver Disease score (HR, 1.02; 1.00-1.04). CONCLUSIONS: Despite the comparable outcomes reported for initial LT among the various etiologies, the outcome of re-LT is significantly worse for NASH cirrhosis.

Is cryptogenic cirrhosis different from NASH cirrhosis?

BACKGROUND & AIMS: We hypothesized that patients currently diagnosed with cryptogenic cirrhosis (CC) have truly 'cryptogenic' liver disease, which is unlikely to have evolved from NASH. The aim of this study is to characterize patients with CC, and compare their characteristics to patients with cirrhosis of other etiologies. METHODS: To investigate this, we compared the clinical characteristics of adults with CC (n = 7,999) to those with cirrhosis caused by non-alcoholic steatohepatitis (NASH) (n = 11,302), alcohol (n = 21,714) and autoimmune hepatitis (n = 3,447), using the UNOS database from 2002-16. We performed an age, gender and year of listing matched comparison of CC and NASH (n = 7,201 in each group), and also stratified patients by the presence of obesity or diabetes mellitus (DM). RESULTS: From 2002 to 2016, patients listed with a diagnosis of NASH increased from about 1% to 16% while CC decreased from 8% to 4%. A logistic regression model using the entire United Network for Organ Sharing data (n = 138,021) suggested that the strongest predictors of NASH were type 2 DM, obesity, age ≥60 years, female gender and white race. Type 2 DM was more common in patients with NASH (53%) than those with CC (29%), alcoholic cirrhosis (16%) and autoimmune hepatitis (16%), and obesity was more common in NASH (65.3%) compared to the other three groups (33-42%). There were more white individuals (82.3%) in the NASH group and a lower prevalence of black, Hispanic and Asian individuals, compared to the other three groups. Hepatocellular carcinoma was more commonly seen in NASH (19% vs. 9-13% in the other groups) and this is not influenced by obesity and type 2 DM. The differences between CC and NASH remained unchanged even when two groups were matched for age, gender and year of listing, or when stratified by the presence or absence of obesity or type 2DM. CONCLUSIONS: Based on risk perspectives, CC should not be equated with the term 'NASH cirrhosis'. LAY SUMMARY: We hypothesized that cryptogenic cirrhosis is a distinct condition from cirrhosis caused by non-alcoholic steatohepatitis (NASH). By comparing cryptogenic cirrhosis with cirrhosis of other causes, we found clear clinical differences. Therefore, cryptogenic cirrhosis should not be considered the same as NASH cirrhosis. Further investigations are required to identify unknown causes of cirrhosis.

Esophageal capsule endoscopy is not the optimal technique to determine the need for primary prophylaxis in patients with cirrhosis.

INTRODUCTION: Capsule endoscopy has been suggested as a potential alternative to endoscopy for detection of esophagogastric varices and severe portal hypertensive gastropathy (PHG). The aim of the study was to determine whether PillCam esophageal capsule endoscopy could replace endoscopy for screening purposes. MATERIAL AND METHODS: Sixty-two patients with cirrhosis with no previous variceal bleeding had PillCam capsule endoscopy and video endoscopy performed on the same day. Sensitivity, specificity, and positive and negative predictive values (PPV, NPV) of capsule endoscopy were compared to endoscopy for the presence and severity of esophageal and gastric varices, PHG and the need for primary prophylaxis. Patients' preference was assessed by a questionnaire. RESULTS: Four (6%) patients were unable to swallow the capsule. Sensitivity, specificity, PPV and NPV of capsule endoscopy for detecting any esophageal varices (92%, 50%, 92%, 50%), large varices (55%, 91%, 75%, 80%), variceal red signs (58%, 87%, 69%, 80%), PHG (95%, 50%, 95%, 50%), and the need for primary prophylaxis (91%, 57%, 78%, 80%) were not optimal, with only moderate agreement (κ) between capsule and upper GI endoscopy. Had only a capsule endoscopy been performed, 12 (21.4%) patients would have received inappropriate treatment. Capsule endoscopy also failed to detect (0/13) gastric varices. The majority of patients ranked capsule endoscopy as more convenient (69%) and their preferred (61%) method. CONCLUSIONS: Despite the preference expressed by patients for capsule endoscopy, we believe that upper GI endoscopy should remain the preferred screening method for primary prophylaxis.

Endoscopic Suturing, an Essential Enabling Technology for New NOTES Interventions.

Natural orifice transluminal endoscopic surgery (NOTES) was developed as a new, minimally invasive approach for various interventions inside the peritoneal cavity. Since the first reports of NOTES animal interventions, various devices have been used for closure of the transluminal entrance site. This article reviews the most commonly used endoscopic closure devices and advantages of the latest generation of endoscopic suturing devices enabling reliable, surgical-quality closure of the full-thickness gastrointestinal wall defects.

New endoscopic platform for endoluminal en bloc tissue resection in the gastrointestinal tract (with videos).

BACKGROUND: Endoscopic removal of gastrointestinal tract lesions is increasingly popular around the world. We evaluated feasibility, safety, effectiveness, and user learning curve of new endoscopic platform for complex intraluminal interventions. METHODS: A novel system, consisting of expandable working chamber with two independent instrument guides (LIG), was inserted into colon. Simulated colonic lesions were removed with endoscopic submucosal (ESD) and submuscular (ESmD) dissection. RESULTS: In all nine in vivo models, an intraluminal chamber and its dynamic tissue retractors (via LIG) provided a stable working space with excellent visualization and adequate access to target tissue. Endoscopic platform facilitated successful completion of 11 en bloc ESDs (mean size 43.0 ± 11.3 mm, mean time 46.3 ± 41.2 min) and eight ESmD (mean size 50.0 ± 14.1 mm, mean time 48.0 ± 21.2 min). The learning curve for ESD using this platform demonstrated three phases: rapid improvement in procedural skills took place during the first three procedures (mean ESD time 98.7 ± 40.0 min). A plateau phase then occurred (procedures 4-7) with mean procedure time 42.0 ± 13.4 min (p = 0.04), followed by another sharp improvement in procedural skills (procedures 8-11) requiring only 16.3 ± 11.4 min (p = 0.03) to complete ESD. Especially dramatic (p = 0.002) was the time difference between the first three procedures (mean time 98.7 ± 40.0 min) and subsequent eight procedures (mean time 29.1 ± 17.9 min). CONCLUSIONS: A newly developed endoscopic platform provides stable intraluminal working space, dynamic tissue retraction, and instrument triangulation, improving visualization and access to the target tissue for safer and more effective en bloc endoscopic submucosal and submuscular dissection. The learning curve for ESD was markedly facilitated by this new endoscopic platform.