Histopathological effects of electrosurgical interventions in an in vivo porcine model of colonic endoscopic mucosal resection.

OBJECTIVE: Endoscopic mucosal resection (EMR) in the colon has been widely adopted, but there is limited data on the histopathological effects of the differing electrosurgical currents (ESCs) used. We used an in vivo porcine model to compare the tissue effects of ESCs for snare resection and adjuvant margin ablation techniques. DESIGN: Standardised EMR was performed by a single endoscopist in 12 pigs. Two intersecting 15 mm snare resections were performed. Resections were randomised 1:1 using either a microprocessor-controlled current (MCC) or low-power coagulating current (LPCC). The lateral margins of each defect were treated with either argon plasma coagulation (APC) or snare tip soft coagulation (STSC). Colons were surgically removed at 72 hours. Two specialist pathologists blinded to the intervention assessed the specimens. RESULTS: 88 defects were analysed (median 7 per pig, median defect size 29×17 mm). For snare ESC effects, 156 tissue sections were assessed. LPCC was comparable to MCC for deep involvement of the colon wall. For margin ablation, 172 tissue sections were assessed. APC was comparable to STSC for deep involvement of the colon wall. Islands of preserved mucosa at the coagulated margin were more likely with APC compared with STSC (16% vs 5%, p=0.010). CONCLUSION: For snare resection, MCC and LPCC did not produce significantly different tissue effects. The submucosal injectate may protect the underlying tissue, and technique may more strongly dictate the depth and extent of final injury. For margin ablation, APC was less uniform and complete compared with STSC.

Thermal Ablation of Mucosal Defect Margins Reduces Adenoma Recurrence After Colonic Endoscopic Mucosal Resection.

BACKGROUND & AIMS: Colorectal cancer (CRC) can be prevented by colonoscopy and polypectomy. Endoscopic mucosal resection (EMR) is performed to remove large laterally spreading colonic lesions that have a high risk of progression to CRC. Endoscopically invisible micro-adenomas at the margins of the EMR site might contribute to adenoma recurrence, which occurs in 15% to 30% of patients who undergo surveillance. We aimed to determine the efficacy of adjuvant thermal ablation of the EMR mucosal defect margin in reducing polyp recurrence. METHODS: We performed a prospective study of 390 patients with large laterally spreading colonic lesions (≥ 20 mm, n = 416) referred for EMR at 4 tertiary centers in Australia. After complete lesion excision by EMR, lesions were randomly assigned to thermal ablation of the post-EMR mucosal defect margin (n = 210) or no additional treatment (controls, n = 206). We performed surveillance colonoscopies with standardized photo documentation and biopsies of the scar after 5 to 6 months. Patient, procedure, and lesion characteristics were similar between the groups. The primary endpoint was detection of lesion recurrence at first surveillance colonoscopy. RESULTS: A significantly lower proportion of patients who received thermal ablation of the post-EMR mucosal defect margin had evidence of recurrence at first surveillance colonoscopy (10/192, 5.2%) than controls (37/176, 21.0%) (P < .001). The relative risk of recurrence in the thermal ablation group was 0.25 compared with the control group (95% confidence interval 0.13-0.48). Rates of adverse events were similar between the groups. CONCLUSIONS: In a multicenter randomized trial, thermal ablation of the post-EMR mucosal defect margin significantly reduced polyp recurrence at first surveillance colonoscopy, compared with no additional treatment. Routine implementation of this simple and safe technique could increase the utility of EMR, decrease surveillance burdens, and reduce morbidity and mortality from CRC. ClinicalTrials.gov no: NCT01789749.

Digital single-operator peroral cholangioscopy-guided biopsy sampling versus ERCP-guided brushing for indeterminate biliary strictures: a prospective, randomized, multicenter trial (with video).

BACKGROUND AND AIMS: Accurately diagnosing indeterminate biliary strictures is challenging but important for patient prognostication and further management. Biopsy sampling under direct cholangioscopic vision might be superior to standard ERCP techniques such as brushing or biopsy sampling. Our aim was to investigate whether digital single-operator cholangioscopy (DSOC) compared with standard ERCP workup improves the diagnostic yield in patients with indeterminate biliary strictures. METHODS: Patients with an indeterminate biliary stricture on the basis of MRCP were randomized to standard ERCP visualization with tissue brushing (control arm [CA]) or DSOC visualization and DSOC-guided biopsy sampling (study arm [SA]). This was a prospective, international, multicenter trial with a procedure-blinded pathologist. RESULTS: The first sample sensitivity of DSOC-guided biopsy samples was significantly higher than ERCP-guided brushing (SA 68.2% vs CA 21.4%, P < .01). The sensitivity of visualization (SA 95.5% vs CA 66.7%, P = .02) and overall accuracy (SA 87.1% vs CA 65.5%, P = .05) were significantly higher in the SA compared with the CA, whereas specificity, positive predictive value, and negative predictive value showed no significant difference. Adverse events were equally low in both arms. CONCLUSIONS: DSOC-guided biopsy sampling was shown to be safe and effective with a higher sensitivity compared with standard ERCP techniques in the visual and histopathologic diagnosis of indeterminate biliary strictures. (Clinical trial registration number: NCT03140007.).

Risk factors for serious adverse events associated with multiband mucosectomy in Barrett's esophagus: an international multicenter analysis of 3827 endoscopic resection procedures.

BACKGROUND AND AIMS: Multiband mucosectomy (MBM) is a widely used technique for the treatment of Barrett's esophagus (BE). However, large multicenter studies enabling a generalizable estimation of the risk of serious adverse events, such as perforation and postprocedural bleeding, are lacking. The aim of this study was to estimate the rate of, and risk factors for, serious adverse events associated with MBM. METHODS: In this retrospective analysis, consecutive patients who underwent MBM for treatment of BE in 14 tertiary referral centers in Europe, the United States, Canada, and Australia were included. Primary outcomes were perforation and postprocedural bleeding rate. Potential risk factors were identified by logistic regression. RESULTS: Between 2001 and 2016, a total of 3827 MBM procedures were performed in 2447 patients (84% male, mean age 66 years, median BE length C2M4). Perforation occurred in 17 procedures (0.4%; 95% confidence interval [CI], 0.3-0.7), of which 15 could be treated endoscopically or conservatively. Female gender was an independent risk factor for perforation (odds ratio [OR], 2.77; 95% CI, 1.02-7.57; P = .05). Postprocedural bleeding occurred after 35 procedures (0.9%; 95% CI, 0.6-1.3). The number of resections (OR, 1.15; 95% CI, 1.06-1.25; P < .001) was significantly associated with postprocedural bleeding. CONCLUSION: The results of this study show that MBM for BE is safe with a low risk of serious adverse events. In addition, most of the adverse events could be managed endoscopically or conservatively. The number of resections was an independent risk factor for postprocedural bleeding.

A systematic description of the post-EMR defect to identify risk factors for clinically significant post-EMR bleeding in the colon.

BACKGROUND AND AIMS: Clinically significant post-EMR bleeding (CSPEB) is the most-frequent serious adverse event after EMR of large laterally spreading colonic lesions (LSLs). There is no proven prophylactic therapy, and it remains a significant drawback of EMR. We aimed to systematically describe and evaluate the features of the post-EMR mucosal defect (PED) and their relationship to CSPEB. METHODS: A prospective study of LSLs referred for EMR at a tertiary center was performed. PEDs without visible features were recorded as bland blue. Nonbland blue (NBB) PED features included size, number, and herniation of submucosal vessels and presence of submucosal hemorrhage, fibrosis, fat, and exposed muscle. NBB PEDs were analyzed for association with CSPEB, defined as bleeding occurring after completion of the procedure necessitating readmission or reintervention. RESULTS: From April 2012 to May 2017, 501 lesions in 501 patients were eligible for analysis. The frequency of CSPEB was 30 of 501 (6.0%). More than or equal to 3 visible vessels was a significant predictor of CSPEB (P = .016). None of the following showed a significant correlation with CSPEB: presence of visible vessels, their diameter, herniation, or other nonvascular PED features. Submucosal vessels were more common in the left-sided colon segment (88.6% vs 78.3%, P = .004) and were significantly larger (20.8% vs 12.1% ≥1 mm, P = .037), more numerous (median 4 vessels [interquartile range, 2-7] vs 2 vessels [interquartile range, 1-4], P < .001), and more often herniated (32% vs 22.2%, P = .022). CONCLUSIONS: More than or equal to 3 visible vessels within the PED may be predictive for CSPEB and may define a target group for real-time prophylactic intervention. No other endoscopically visible features of the PEDs were predictive of CSPEB. (Clinical trial registration number: NCT03117400.).

Wide-field endoscopic mucosal resection versus endoscopic submucosal dissection for laterally spreading colorectal lesions: a cost-effectiveness analysis.

OBJECTIVE: To compare the cost-effectiveness of endoscopic submucosal dissection (ESD) and wide-field endoscopic mucosal resection (WF-EMR) for removing large sessile and laterally spreading colorectal lesions (LSLs) >20 mm. DESIGN: An incremental cost-effectiveness analysis using a decision tree model was performed over an 18-month time horizon. The following strategies were compared: WF-EMR, universal ESD (U-ESD) and selective ESD (S-ESD) for lesions highly suspicious for containing submucosal invasive cancer (SMIC), with WF-EMR used for the remainder. Data from a large Western cohort and the literature were used to inform the model. Effectiveness was defined as the number of surgeries avoided per 1000 cases. Incremental costs per surgery avoided are presented. Sensitivity and scenario analyses were performed. RESULTS: 1723 lesions among 1765 patients were analysed. The prevalence of SMIC and low-risk-SMIC was 8.2% and 3.1%, respectively. Endoscopic lesion assessment for SMIC had a sensitivity and specificity of 34.9% and 98.4%, respectively. S-ESD was the least expensive strategy and was also more effective than WF-EMR by preventing 19 additional surgeries per 1000 cases. 43 ESD procedures would be required in an S-ESD strategy. U-ESD would prevent another 13 surgeries compared with S-ESD, at an incremental cost per surgery avoided of US$210 112. U-ESD was only cost-effective among higher risk rectal lesions. CONCLUSION: S-ESD is the preferred treatment strategy. However, only 43 ESDs are required per 1000 LSLs. U-ESD cannot be justified beyond high-risk rectal lesions. WF-EMR remains an effective and safe treatment option for most LSLs. TRIAL REGISTRATION NUMBER: NCT02000141.

Cold-forceps avulsion with adjuvant snare-tip soft coagulation (CAST) is an effective and safe strategy for the management of non-lifting large laterally spreading colonic lesions.

BACKGROUND AND AIMS: Non-lifting large laterally spreading colorectal lesions (LSLs) are challenging to resect endoscopically and often necessitate surgery. A safe, simple technique to treat non-lifting LSLs endoscopically with robust long-term outcomes has not been described. METHODS: In this single-center prospective observational study of consecutive patients referred for endoscopic mucosal resection (EMR) of LSLs ≥ 20 mm, LSLs not completely resectable by snare because of non-lifting underwent standardized completion of resection with cold-forceps avulsion and adjuvant snare-tip soft coagulation (CAST). Scheduled surveillance colonoscopies were performed at 4 - 6 months (SC1) and 18 months (SC2). Primary outcomes were endoscopic evidence of adenoma clearance and avoidance of surgery. The secondary outcome was safety. RESULTS: From January 2012 to October 2016, 540 lifting LSLs (82.2 %) underwent complete snare excision at EMR. CAST was required for complete removal in 101 non-lifting LSLs (17.8 %): 63 naïve non-lifting lesions (NNLs; 62.7 %) and 38 previously attempted non-lifting lesions (PANLs; 37.3 %). PANLs were smaller (P < 0.001) and more likely to be non-granular (P = 0.001) than the lifting LSLs. NNLs were of similar size (P = 0.77) and morphology (P = 0.10) to the lifting LSLs. CAST was successful in all cases and adverse events were comparable to lifting LSLs resected by complete snare excision. Recurrence at SC1 was comparable for PANLs (15.2 %) and lifting LSLs (15.3 %; P = 0.99), whereas NNLs recurred more frequently (27.5 %; P = 0.049); however, surgery was no more common for either type of non-lifting LSL than for lifting LSLs. CONCLUSION: CAST is a safe, effective, and surgery-sparing therapy for the majority of non-lifting LSLs. It is easy to use, inexpensive, and does not require additional equipment.

Wide-field piecemeal cold snare polypectomy of large sessile serrated polyps without a submucosal injection is safe.

BACKGROUND AND STUDY AIMS : Large series suggest endoscopic mucosal resection is safe and effective for the removal of large (≥ 10 mm) sessile serrated polyps (SSPs), but it exposes the patient to the risks of electrocautery, including delayed bleeding. We examined the feasibility and safety of piecemeal cold snare polypectomy (pCSP) for the resection of large SSPs. METHODS: Sequential large SSPs (10 - 35 mm) without endoscopic evidence of dysplasia referred over 12 months to a tertiary endoscopy center were considered for pCSP. A thin-wire snare was used in all cases. Submucosal injection was not performed. High definition imaging of the defect margin was used to ensure the absence of residual serrated tissue. Adverse events were assessed at 2 weeks and surveillance was planned for between 6 and 12 months. RESULTS: 41 SSPs were completely removed by pCSP in 34 patients. The median SSP size was 15 mm (interquartile range [IQR] 14.5 - 20 mm; range 10 - 35 mm). The median procedure duration was 4.5 minutes (IQR 1.4 - 6.3 minutes). There was no evidence of perforation or significant intraprocedural bleeding. At 2-week follow-up, there were no significant adverse events, including delayed bleeding and post polypectomy syndrome. First follow-up has been undertaken for 15 /41 lesions at a median of 6 months with no evidence of recurrence. CONCLUSIONS: There is potential for pCSP to become the standard of care for non-dysplastic large SSPs. This could reduce the burden of removing SSPs on patients and healthcare systems, particularly by avoidance of delayed bleeding.

Outcomes after endoscopic resection of large laterally spreading lesions of the papilla and conventional ampullary adenomas are equivalent.

BACKGROUND: Endoscopic resection of ampullary adenomas is a safe and effective alternative to surgical resection. A subgroup of patients have large laterally spreading lesions of the papilla Vateri (LSL-P), which are frequently managed surgically. Data on endoscopic resection of LSL-P are limited and long-term outcomes are unknown. The aim of this study was to compare the outcomes of endoscopic resection of LSL-P with those of standard ampullary adenomas. METHODS: A retrospective analysis of a prospectively collected and maintained database was conducted. LSL-P was defined as extension of the lesion ≥ 10 mm from the edge of the ampullary mound. Piecemeal endoscopic mucosal resection of the laterally spreading component was followed by resection of the ampulla. Patient, lesion, and procedural data, as well as results of endoscopic follow-up, were collected. RESULTS: 125 lesions were resected. Complete endoscopic resection was achieved in 97.6 % at the index procedure (median lesion size 20 mm, interquartile range [IQR] 13 - 30 mm). Compared with ampullary adenomas, LSL-Ps were significantly larger (median 35 mm vs. 15 mm), contained a higher rate of advanced pathology (38.6 % vs. 18.5 %), and had higher rates of intraprocedural bleeding (50 % vs. 24.7 %) and delayed bleeding (25.0 % vs. 12.3 %). Both groups had similar rates of histologically proven recurrence at first surveillance (16.4 % vs. 17.9 %). Median follow-up for the entire cohort was 18.5 months. For patients with at least two surveillance endoscopies (n = 68; median follow-up 29 months, IQR 18 - 48 months), 95.6 % were clear of disease and considered cured. CONCLUSIONS: LSL-P can be resected endoscopically with comparable outcomes to standard ampullectomy, albeit with a higher risk of bleeding. Endoscopic treatment should be considered as an alternative to surgical resection, even for large LSL-P.

Prediction of Clinically Significant Bleeding Following Wide-Field Endoscopic Resection of Large Sessile and Laterally Spreading Colorectal Lesions: A Clinical Risk Score.

OBJECTIVES: Clinically significant bleeding (CSPEB) is the most frequent adverse event following wide-field endoscopic mucosal resection (WF-EMR) of large sessile and laterally spreading colorectal lesions (LSL). There is limited knowledge regarding accurate prediction of CSPEB. We aimed to derive a score to predict the risk of CSPEB. METHODS: Data on patient and lesion characteristics and outcomes from WF-EMRs of LSL ≥20 mm at 8 referral hospitals were analyzed. The cohort was divided at random into equal sized training and test groups. Independent predictors of CSPEB in the training cohort were identified by multiple logistic regression analysis and used to develop a risk score. The performance of this score was assessed in the independent test cohort. RESULTS: Over 80 months to June 2015, 2,128 patients with 2,424 LSL were referred for WF-EMR. Two thousand and twelve patients were eligible for analysis. There were 135 cases of CSPEB (6.7%). In the training cohort of 1,006 patients, the independent predictors of CSPEB were lesion size >30 mm (odds ratio (OR) 2.5), proximal colonic location (OR 2.3), presence of a major comorbidity (OR 1.5), and epinephrine in injection solution (OR 0.57). The derived risk score comprised lesion size >30 mm (2 points), proximal colon (2 points), presence of major comorbidity (1 point), and absence of epinephrine use (1 point). The probabilities of CSPEB for scores of 0, 1, 2, 3, 4, and ≥5 in the training cohort were 1.5, 2.0, 5.6, 7.8, 9.1, and 17.5% and were 0.9, 6.7, 4.9, 6.2, 9.0, and 15.7% in the test cohort. The probabilities of CSPEB in those with low (score 0-1), medium (score 2-4), and elevated (score 5-6) risk levels were 1.7, 7.1, and 17.5% in the training cohort and 3.4, 6.2, and 15.7% in the test cohort. CONCLUSIONS: Patients at elevated risk of CSPEB can be identified using four readily available variables. This knowledge may improve the management of those undergoing WF-EMR and assist in designing studies evaluating CSPEB.

Extended endoscopic mucosal resection does not reduce recurrence compared with standard endoscopic mucosal resection of large laterally spreading colorectal lesions.

BACKGROUND AND AIMS: Effective interventions to prevent residual and/or recurrent adenoma (RRA) after EMR of large sessile and laterally spreading colorectal lesions (LSL) are yet to be determined. RRA may occur due to inconspicuous adenoma at the EMR margin. We aimed to determine the efficacy and safety of extended EMR (X-EMR) compared with standard EMR (S-EMR). METHODS: A single-center post hoc analysis of LSL ≥20 mm referred for treatment was performed. S-EMR was the standard sequential inject and resect method including a 1-mm to 2-mm margin of normal mucosa around the lesion. With X-EMR, at least a 5-mm margin of normal mucosa was excised. Patient and lesion characteristics and procedural outcomes were recorded. The primary endpoint was RRA at first surveillance colonoscopy at 4 months. RESULTS: Between January 2009 and May 2011, 471 lesions (mean size, 37.9 mm) in 424 patients were resected by S-EMR, and between January 2012 and December 2013, 448 lesions (mean size, 39.1 mm) in 396 patients were resected by X-EMR. Resection was successful in 92.3% and 92.6% of referred lesions in the S-EMR and X-EMR groups, respectively (P = .978). X-EMR was independently associated with a higher risk of intraprocedural bleeding (IPB) (odds ratio, 3.1; 95% confidence interval [CI], 2.0-5.0; P < .001) but not other adverse events. RRA was present in 39 of 333 patients (11.7%) and 30 of 296 patients (10.1%) in the S-EMR and X-EMR groups, respectively (P = .15). X-EMR was not related to recurrence (hazard ratio, 0.8; 95% CI, 0.5-1.3; P = .399). CONCLUSIONS: X-EMR does not reduce RRA and increases the risk of IPB compared with S-EMR. Alternative methods for the prevention of RRA are required.

Endoscopic mucosal resection of large and giant lateral spreading lesions of the duodenum: success, adverse events, and long-term outcomes.

BACKGROUND AND AIMS: Large sporadic duodenal adenomas are uncommon but they harbor malignant potential, which requires consideration of definitive treatment. EMR is gaining acceptance as an effective and safe alternative to high-risk surgical procedures, but data on long-term outcomes are limited. Herein we describe the short- and long-term outcomes of these lesions in a tertiary referral center. METHODS: Prospectively collected data were analyzed to identify risk factors for adverse events and outcomes. Patient demographics, lesion characteristics, and procedural technical data were collected. RESULTS: From 2007 to 2015, 106 adenomas ≥10 mm were resected (mean patient age, 69 years; 54% male; median size, 25 mm; interquartile range [IQR], 19-40). Complete endoscopic resection was achieved in 96%. Intraprocedural bleeding occurred in 43% of cases and was associated with lesion size (P < .001), number of resected specimens (P = .003), and longer procedures (P = .001). Delayed bleeding occurred in 15% (56% did not require active intervention) and was associated with lesion size (P = .03). Perforation occurred in 3 patients. The 30-day mortality was 0%. Median follow-up was 22 months (IQR, 7-45). Histologically proven adenoma recurrence was identified and treated in 12 of 83 patients (14.4%) on first surveillance endoscopy. For the 53 patients for whom follow-up ≥12 months was available (median follow-up, 36 months; IQR, 24-51), 48 patients (90.6%) were free of adenoma and considered cured. CONCLUSIONS: In a tertiary referral center, endoscopic resection of duodenal adenomas is a safe and effective alternative to surgery. Lesion size is strongly associated with adverse events, particularly intraprocedural bleeding and delayed bleeding. Good long-term outcomes are demonstrated.

Long-term outcomes of a primary complete endoscopic resection strategy for short-segment Barrett's esophagus with high-grade dysplasia and/or early esophageal adenocarcinoma.

BACKGROUND AND AIMS: Complete endoscopic resection (CER) of Barrett's esophagus (BE) with high-grade dysplasia (HGD) and early esophageal adenocarcinoma (EEA) is a comprehensive and precise staging tool and may produce a sustained treatment response, preventing metachronous disease. There are limited data on long-term clinical outcomes and the sustainability of dysplasia eradication after CER. We aimed to describe long-term outcomes of a primary CER strategy of BE with HGD/EEA. METHODS: Patients with biopsy-proven HGD and EEA in short-segment BE (≤ 3 cm in circumferential length and ≤ 5 cm in maximal length) underwent staged CER by multiband mucosectomy or the cap method. The primary endpoint was remission of HGD or EEA (complete resection of HGD/EEA), dysplasia (complete resection of any dysplasia), and complete resection of intestinal metaplasia. RESULTS: Of 153 patients (126 HGD, 27 EEA; 83.7% male, median age of 66 years) considered suitable for CER, 138 met all inclusion criteria. CER was technically successful in all patients and was established after a median of 2 sessions. Covert synchronous EEA was found in 1 patient. At a mean follow-up of 40.7 months by intention-to-treat analysis, complete remission of HGD/EEA, dysplasia, and intestinal metaplasia was achieved in 98.5%, 89.1%, and 71.0%, respectively. In 47.1% of patients, CER changed the histological grade compared with pretreatment biopsies (28.1% downstaged and 19.0% upstaged). Esophageal dilation was performed in 36.8% in a mean of 2.5 sessions. At the end of follow-up, 96.4% of patients had no or minimal dysphagia and 90.6% of patients found CER an acceptable treatment. CONCLUSIONS: On long-term follow-up, a primary CER strategy was a highly effective, safe, and durable treatment for HGD and EEA. Despite the need for post-CER dilation in one-third of patients, the majority found it an acceptable treatment on long-term follow-up.

Efficacy of viscous budesonide slurry for prevention of esophageal stricture formation after complete endoscopic mucosal resection of short-segment Barrett's neoplasia.

BACKGROUND AND AIMS: Complete endoscopic resection (CER) of short-segment Barrett's esophagus with high grade dysplasia (HGD) and early esophageal adenocarcinoma (EEA) is a precise staging tool and achieves durable disease control. The major drawback is development of post-endoscopic resection esophageal stricture (PERES). No effective therapy to prevent PERES has been described. Viscous budesonide slurry (VBS) may have a role in the prevention of PERES by suppressing the post-CER inflammatory process. The study aim was to evaluate the efficacy of VBS for the prevention of PERES. METHODS: Prospective data were collected on patients referred for CER of HGD or EEA. After January 2012, patients routinely received VBS (two 0.5-mg/2-mL budesonide respules mixed with sucralose) twice daily for 6 weeks following each stage of the CER schedule. All patients received high dose proton pump inhibitor therapy for the duration of CER and the following 3 months. Patients had no other intervention to prevent PERES. A validated dysphagia score was used (0 - 4, no dysphagia to aphagia). Endoscopic dilation was performed for dysphagia. Patients receiving VBS were compared with historical controls. The primary endpoint was the need for dilation. RESULTS: Between January 2008 and January 2015, 104 of 116 eligible patients completed CER. The VBS group (n = 29) and non-VBS group (n = 75) had similar patient, disease, and procedural characteristics. Dilations were needed in 13.8 % vs. 37.3 % (P = 0.03), with a median of one vs. two procedures (P = 0.01), and median dysphagia score during CER of 0 vs. 1 (P = 0.02) in the VBS and non-VBS groups, respectively. No VBS-related adverse events were noted. CONCLUSION: In this pilot study VBS significantly reduced PERES and shortened the dilation program after CER.

Prophylactic clipping for the prevention of bleeding following wide-field endoscopic mucosal resection of laterally spreading colorectal lesions: an economic modeling study.

BACKGROUND AND STUDY AIMS: Clinically significant bleeding (CSPEB) is the most common adverse event following endoscopic mucosal resection (EMR) of large sessile and laterally spreading colorectal lesions (LSLs), and is associated with morbidity and resource utilization. CSPEB occurs more frequently with proximal LSLs. Prophylactic clipping of the post-EMR defect may be beneficial in CSPEB prevention. The aim of this study was to determine the cost-effectiveness of a prophylactic clipping strategy. We hypothesized that prophylactic clipping in the proximal colon was cost-effective. PATIENTS AND METHODS: An economic model was applied to outcomes from the Australian Colonic Endoscopic Mucosal Resection (ACE) Study. Clip distances of 3, 5, 8, and 10 mm were analyzed. The cost of treating CSPEB was determined from an independent costing agency. The funds needed to spend (FNS) was the cost incurred in order to prevent one episode of CSPEB. A break-even analysis was performed to determine cost equivalence of the costs of clipping and CSPEB. RESULTS: Outcomes of 1717 LSLs (mean size 35.8 mm; 52.6 % proximal colon) that underwent EMR were analyzed. The overall rate of CSPEB was 6.4 % (proximal 8.9 %; distal 3.7 %). Endoscopic management was required in 45 % of CSPEB episodes. With a clip distance of 3 mm, the expected cost of prophylactic clipping was €â€Š1106 per lesion compared with €â€Š157 per lesion for the expected cost of CSPEB without clipping. At 100 % clipping efficacy, the FNS was €â€Š14 826 (proximal and distal lesions €â€Š9309 and €â€Š29 540, respectively). A clip price of €â€Š10.35 was required for the cost of clipping to offset the cost of CSPEB. CONCLUSIONS: A prophylactic clipping strategy is not cost-effective and at present cannot be justified for all lesions or selectively for lesions in the proximal colon. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01368289).

Comparison of the histopathological effects of two electrosurgical currents in an in vivo porcine model of esophageal endoscopic mucosal resection.

BACKGROUND AND STUDY AIMS: Stricture formation is the main limitation of endoscopic resection in the esophagus. The optimal electrosurgical current (ESC) for endoscopic resection in the esophagus and other gastrointestinal sites is unknown. There may be a relationship between the type of ESC used and the development of post-procedure esophageal stricture. Unlike the low power coagulating current (LPCC), the microprocessor-controlled current (MCC), which alternates between short pulse cutting and coagulation, avoids high peak voltages that are thought to result in deep thermal injury. The aim of this study was to determine the histopathological variables associated with these two commonly employed ESCs used for esophageal endoscopic resection. METHODS: Standardized endoscopic resection of normal mucosa by band mucosectomy was performed by a single endoscopist in 12 adult pigs. The procedures were randomized 1 : 1 to either LPCC (ERBE 100 C at 25 W) or MCC (ERBE Endocut Q, Effect 3). Necropsy and esophagectomy were performed at 72 hours after the procedure. Two histopathologists, who were blinded to the ESC allocation, independently assessed the presence and depth of ulceration, necrosis and inflammation. RESULTS: A total of 45 resections were analyzed. In the LPCC and MCC groups, ulceration extending into the muscularis propria was present in 9/24 (37.5 %) and 1/21 (4.8 %) resected specimens, respectively (P = 0.04). Necrosis extending into the muscularis propria was present in 13/24 (54.1 %) and 1/21 (4.8 %) resected specimens, respectively (P = 0.002). One case of microperforation with muscularis propria injury was noted in the LPCC group compared with none in the MCC group. The quantified mean depth of ulceration, necrosis, and acute inflammation was significantly greater in the LPCC group.  CONCLUSIONS: In an in vivo porcine survival model of esophageal endoscopic mucosal resection, the use of MCC resulted in significantly less deep thermal ulceration, necrosis, and acute inflammation compared with LPCC. MCC should be used in preference over LPCC for esophageal endoscopic resection.

Prophylactic endoscopic coagulation to prevent bleeding after wide-field endoscopic mucosal resection of large sessile colon polyps.

BACKGROUND & AIMS: Clinically significant postendoscopic mucosal resection bleeding (CSPEB) is the most frequent significant complication of wide-field endoscopic mucosal resection (WF-EMR) of advanced mucosal neoplasia (sessile or laterally spreading colorectal lesions > 20 mm). CSPEB requires resource-intensive management and there is no strategy for preventing it. We investigated whether prophylactic endoscopic coagulation (PEC) reduces the incidence of CSPEB. METHODS: We performed a prospective randomized controlled trial of 347 patients (mean age, 67.1 y; 55.3% with proximal colonic lesions) undergoing WF-EMR for advanced mucosal neoplasia at 3 Australian tertiary referral centers. Patients were assigned randomly (1:1) to groups receiving PEC (n = 172) or no additional therapy (n = 175, controls). PEC was performed with coagulating forceps, applying low-power coagulation to nonbleeding vessels in the resection defect. CSPEB was defined as bleeding requiring admission to the hospital. The primary end point was the proportion of CSPEB. RESULTS: Patients in each group were similar at baseline. CSPEB occurred in 9 patients receiving PEC (5.2%) and 14 controls (8.0%; P = .30). CSPEB was associated significantly with proximal colonic location on multivariate analysis (odds ratio, 3.08; P = .03). Compared with the proximal colon, there was a significantly greater number (3.8 vs 2.1; P = .002) and mean size (0.5-1 vs 0.3-0.5 mm; P = .04) of visible vessels in the distal colon. CONCLUSIONS: PEC does not significantly decrease the incidence of CSPEB after WF-EMR. There were significantly more and larger vessels in the WF-EMR mucosal defect of distal colonic lesions, yet CSPEB was more frequent with proximal colonic lesions. ClinicalTrials.gov NCT01368731.

Early metal stent insertion fails to prevent stricturing after single-stage complete Barrett's excision for high-grade dysplasia and early cancer.

BACKGROUND: Barrett's esophagus with high-grade dysplasia (HGD) or intramucosal adenocarcinoma (IMC) can be effectively treated by single-session EMR, resulting in complete Barrett's excision (CBE). CBE provides accurate histology for staging and clinical confirmation of neoplasia eradication but is limited by a high risk of esophageal stricture formation. OBJECTIVE: To evaluate the effectiveness of prophylactic temporary esophageal stenting to prevent post-CBE stricture formation. DESIGN AND SETTING: Single-center, investigator-initiated feasibility study. PATIENTS: Circumferential, short-segment Barrett's esophagus (≤C3≤M5) with HGD or IMC. INTERVENTION: Single-stage CBE and insertion of a fully covered metal esophageal stent at 10 days that was removed at 8 weeks. Patients were followed for a minimum of 2 surveillance endoscopies. MAIN OUTCOME MEASUREMENT: Symptomatic esophageal stricture formation. RESULTS: At the end of the follow-up period, 8 patients (57.1%) required esophageal dilation for symptomatic CBE-related (n = 7) or stent-related (n = 4) strictures. A median of 3 surveillance endoscopies were performed over a median endoscopic follow-up of 17 months (range 4-25 months). Single-stage CBE successfully eliminated Barrett's intestinal metaplasia and neoplasia in 71.4% and 92.9% of patients, respectively. Four patients were admitted to the hospital, and 4 patients had early stent removal because of pain or dysphagia. LIMITATIONS: Single-center feasibility study. CONCLUSIONS: In a prospective study evaluating prophylactic esophageal stent insertion after single-stage CBE, esophageal strictures formed in more than of half the study cohort, and stents were associated with significant morbidity. An alternative method to reduce stricture formation is required. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01554280.).

Australian clinical practice guidelines for the diagnosis and management of Barrett's esophagus and early esophageal adenocarcinoma.

Barrett's esophagus (BE), a common condition, is the only known precursor to esophageal adenocarcinoma (EAC). There is uncertainty about the best way to manage BE as most people with BE never develop EAC and most patients diagnosed with EAC have no preceding diagnosis of BE. Moreover, there have been recent advances in knowledge and practice about the management of BE and early EAC. To aid clinical decision making in this rapidly moving field, Cancer Council Australia convened an expert working party to identify pertinent clinical questions. The questions covered a wide range of topics including endoscopic and histological definitions of BE and early EAC; prevalence, incidence, natural history, and risk factors for BE; and methods for managing BE and early EAC. The latter considered modification of lifestyle factors; screening and surveillance strategies; and medical, endoscopic, and surgical interventions. To answer each question, the working party systematically reviewed the literature and developed a set of recommendations through consensus. Evidence underpinning each recommendation was rated according to quality and applicability.