Resection Of Large Colorectal Lesions Research Articles

Tip-in Versus Conventional Endoscopic Mucosal Resection for Colorectal Neoplasia: A Systematic Review and Meta-analysis.

Early-stage gastrointestinal neoplasms are frequently treated with conventional endoscopic mucosal resection (C-EMR). However, C-EMR frequently leads to incomplete resection of large colorectal lesions. Tip-in endoscopic mucosal resection (EMR), which was recently introduced for en bloc resection of colorectal neoplasms, minimizes slippage during the procedure. We conducted a systematic review and meta-analysis of published studies that compared Tip-in EMR with conventional EMR. We searched several electronic databases and included studies that reported on the primary outcomes of en bloc resection rate and complete resection rate, as well as secondary outcomes such as procedure time and procedure-related complications (including perforation and delayed bleeding rate). We used a random effects model to calculate odds ratios (ORs) with 95% CIs for dichotomous data and weighted mean differences with 95% CIs for continuous data. We also conducted several sensitivity analyses to assess the robustness of our findings. A total of 11 studies involving 1244 lesions (684 in the Tip-in EMR group and 560 in C-EMR group) were included in the meta-analysis. Our meta-analysis showed that compared with conventional EMR, Tip-in EMR significantly increased the en bloc resection rate in patients with colorectal neoplasia (OR=3.61; 95% CI, 2.09-6.23; P <0.00001; I2 =0%) and had a higher complete resection rate (OR=2.49; 95% CI, 1.65-3.76; P <0.0001; I2 =0%). However, the procedure time and rates of procedure-related complications did not differ significantly between the 2 groups. Tip-in EMR outperformed C-EMR for both the en bloc and complete resection of colorectal lesions with similar rates of procedural complications.

WEO Newsletter.

WEO Newsletter.

Feasibility of progressive polyp contraction with underwater endoscopic mucosal resection in ≥ 20 mm superficial colorectal lesions.

Background and study aims Underwater endoscopic mucosal resection (UEMR) does not always result in en bloc resection of large colorectal lesions. The aim of this study was to demonstrate the feasibility of en bloc resection with progressive polyp contraction with underwater endoscopic mucosal resection (PP-CUE) of large, superficial colorectal lesions. The advantage of PP-CUE is to enable resection of a superficial non-polypoid lesion that is larger than the snare diameter. Patients and methods Eleven consecutive lesions in ten patients who underwent UEMR with PP-CUE of large superficial colorectal lesions (20 mm or greater) were included. Results The median lesion diameter was 24 mm (interquartile range [IQR], 20-24 mm). All lesions were larger than the 15-mm rotatable snare that was used. Median procedure time and PP-CUE time were 11 minutes (IQR, 8.5-12.3) and 2.3 minutes (IQR, 1.9-3.4), respectively. Pathological diagnoses of resected specimens included six adenomas, three sessile serrated lesions, and two slightly invasive submucosal carcinomas. En bloc and R0 resection rates were both 91 % (10/11). No adverse events occurred. Conclusions PP-CUE is useful to resect superficial non-polypoid colorectal lesions 20 to 25 mm in diameter in an en bloc fashion.

ID: 3523731 ENDOSCOPIC SUBMUCOSAL DISSECTION OF RECTAL LESIONS AFTER PRIOR FAILED ENDOSCOPIC MUCOSAL RESECTION IS SAFE AND EFFECTIVE

Endoscopic submucosal dissection (ESD) allows for en bloc resection of large colorectal lesions. Despite this advantage, endoscopic mucosal resection (EMR) remains the standard resection technique employed by most endoscopists in the United States. When EMR is performed prior to ESD, there is concern that this can introduce scar tissue that would make submucosal dissection more challenging. Herein, we examine efficacy and safety of rectal ESD after failed EMR.

Endoscopic Shielding With Platelet-rich Plasma After Resection of Large Colorectal Lesions: Stroma Microanatomy Raises Oncological Safety Issues.

Endoscopic Shielding With Platelet-rich Plasma After Resection of Large Colorectal Lesions: Stroma Microanatomy Raises Oncological Safety Issues.

Incidence of microscopic residual adenoma after complete wide-field endoscopic resection of large colorectal lesions: evidence for a mechanism of recurrence

EMR of large (≥2 cm) nonpedunculated colorectal polyps (LNPCPs) is associated with high rates of recurrent/residual adenoma, possibly because of microadenoma left at the margin of resection. Data supporting this mechanism are required. We aimed to determine the incidence of residual microadenoma at the defect margin and base after EMR. We performed a retrospective observational study of patients undergoing EMR of large LNPCPs with the lateral defect margin further resected using the EndoRotor device (Interscope Medical, Inc, Worcester, Mass, USA) after confirming no visible residual adenomatous tissue. Aspects of the defect base were also resected in selected patients. Patients underwent surveillance at 3 to 6 months. Resection of the normal defect margin was performed in 41 patients and of aspects of the base in 21 patients. Mean lesion size was 43.0mm (range, 20-130). Microscopic residual lesion was detected in the margin of apparently normal mucosa in 8 cases (19%). In 7 cases this was an adenoma, and in 1 case a serrated lesion was found at the margin of a resected tubular adenoma. Microscopic residual lesion was detected at the base in 5 of 21 cases. Residual/recurrent adenoma was detected in 2 patients. Neither had residual microadenoma at the lateral margin or base detected after the primary resection. Microscopic residual adenoma after wide-field EMR was detected in 19% of cases at the apparently normal defect margin and at the resection base in 5 of 21 cases. This study confirms the presence of residual microadenoma after resection of LNPCPs, providing evidence for the mechanism of recurrence.

Endoscopic Shielding With Platelet-rich Plasma After Resection Of Large Colorectal Lesions.

Platelet-rich plasma (PRP) has demonstrated efficacy as submucosal injection before endoscopic mucosal resection or local injection after endoscopic submucosal dissection of nonpedunculated colorectal lesions. The EndoPRP study was a prospective single-center study to analyze the efficacy of PRP shield after endoscopic mucosal resection of large nonpedunculated colorectal lesio with impossible clip closure, assessed by the incidence of delayed bleeding (DB) and delayed perforation, and percentage of mucosal restoration after 4 weeks (mucosal healing rate). Shielding technique with PRP was performed in 4 patients, aged 52 to 80, with 4 lesions at rectum (mean size 53.7±20.6 mm, range 35 to 80 mm). DB occurred in 1 lesion (25% of all lesions), no required blood transfusion or endoscopic treatment. No postoperative delayed perforation occurred. Mucosal healing rate was of 78.6% after 4 weeks. PRP shield failed in prevent DB, probably due to migration and failure in the adherence in large wounds. Future comparative studies are needed to confirm these data.

Recurrence After Endoscopic Mucosal Resection: Early and Late Incidence, Treatment Outcomes, and Outcomes in Non-Overt (Histologic-Only) Recurrence

Recurrence After Endoscopic Mucosal Resection: Early and Late Incidence, Treatment Outcomes, and Outcomes in Non-Overt (Histologic-Only) Recurrence

Mo1689 DOUBLE SCOPE COLORECTAL ESD USING A GEL-BASED TAMIS ACCESS PLATFORM

Endoscopic submucosal dissection (ESD) is a promising endoscopic procedure that is increasingly being used for endoscopic resection of large colorectal lesions that may be difficult to remove en-bloc by snare polypectomy. The greatest challenge for ESD remains technical difficulty in achieving optimal traction. In the following study, we evaluate the use of Gel-based Transanal Access Platform, typically used for Transanal Minimally Invasive Surgery (TAMIS) to facilitate ESD of colorectal lesions by facilitating use of two separate endoscopes simultaneously. Patients undergoing colorectal ESD were consented for use of this device during their procedure. If difficulty with traction occurred during the submucosal dissection portion of the procedure, the device was employed as follows: A 4x4 cm Gel based-TAMIS access device was inserted into the anal canal. Two access holes were made in the gel cover 2cm apart with the pre-supplied trocars to allow for the passage of a 1T therapeutic gastroscope and an ultraslim gastroscope. After submucosal injection and circumferential incision, the pediatric forceps were passed through the working channel of the ultraslim scope, and the edge of the lesion was grasped and then manipulated to allow for dynamic traction of the lesion. Outcomes measured included procedure time, traction assessment, interference between two scopes and adverse events including anal discomfort and post procedure incontinence. Over the study period 5 subjects have required the TAMIS device to assist with traction. All cases have been performed by a single endoscopist. The average procedure time with use of the device over 5 cases was 19mins per 1cm of lesion. Traction was felt to be excellent in all cases. There was minimal to no interference with the second scope. All cases resulted in en-bloc and R0 resections. 1 case was a T2 cancer with R0 resection. 1 case was intramucosal cancer. 3 cases were tubulovillous adenoma with high grade dysplasia. There were no complications in all 5 cases. Zero patients complained of anorectal pain after the procedure or experienced incontinence. By using a commercially available Transanal Access Platform for the first time in an endoscopic procedure, there was greater ease performing ESD. This device allowed the insertion of an additional scope which provided more traction and assisted in resecting each lesion without any reported friction between the two scopes. The set-up of this device is simple and this device appears suitable not only for laparoscopic surgical procedures but also for endoscopic interventions. This is a lower cost option for ESD traction than other proprietary traction devices on the market. Further studies are underway to determine the technical success, easy of use, and safety of this dual scope with TAMIS platform technique for colorectal ESD.Second scope with Traction assisting with Dual Knife DissectionView Large Image Figure ViewerDownload Hi-res image Download (PPT)

Prevention of Postpolypectomy Bleeding with Clips

Recent evidence suggests that prophylactic clipping can reduce postpolypectomy bleeding after resection of large colorectal lesions, but uncertainty

Evaluation of recurrence and surgical complementation rates after endoscopic resection of large colorectal non-pedunculated lesions.

the process that leads to the development of colorectal cancer takes many years and most tumors originate from polyps and non-polypoid lesions. Techniques of endoscopic resection are surgical treatment options, even in case of large lesions or with initial invasion. This study aimed to evaluate the recurrence and surgical complementation rates after endoscopic resection of large colorectal non-pedunculated lesions. a retrospective, longitudinal and descriptive trial was performed via an analysis of colonoscopies with the resection of non-pedunculated lesions larger than 3 cm, performed between 2014 and 2017. sixty-two lesions were included from 61 patients and 32 (52.5 %) were female. The age ranged from 36 to 89 years, with a mean age of 60.5 years. Lesions had an average diameter of 40.08 mm, ranging from 30 to 80 mm. Regarding the location of the lesions, the most frequent colonic segments were the ascending and rectum, both accounting for 22.6 %. Considering the morphologic endoscopic classification, 67.7 % were granular laterally spreading tumors (LST), 38.8 % were homogeneous granular and 29 % were mixed granular. The most frequent histological types were tubulovillous adenoma (30.7 %) and intramucosal adenocarcinoma (29 %). The resection technique was piecemeal mucosectomy in 85.5 %. Five lesions were removed by en bloc mucosectomy, two (3.2 %) by endoscopic submucosal dissection (ESD) and two (3.2 %) by a hybrid technique. The recurrence rate was 25.8 %. Three patients needed complementary surgical treatment and the clinical success of endoscopic treatment was 95.1 %. recurrence rate after endoscopic resection of large colorectal lesions was 25.8 % and surgical complementation rate due to failure in the endoscopic treatment of recurrence was 4.8 %.

Intra-procedural and delayed bleeding after resection of large colorectal lesions: The SCALP study.

The safety of endoscopic resection of large colorectal lesions (LCLs) (≥20 mm) is clinically relevant. The aim of the present study was to assess the rate of post-resection adverse events (AEs) in a real-life setting. In a prospective, multicentre, observational study, data from consecutive resections of LCLs over a 6-month period were collected in 24 centres. Patients were followed up at 15 days from resection for AEs. The primary endpoint was intra-procedural bleeding according to lesion morphology. Secondary endpoints were delayed bleeding and perforation. Patient and polyp characteristics, and polypectomy techniques were analysed with respect to the bleeding events. In total, 1504 patients (female/male: 633/871, mean age, 66.1) with 1648 LCLs (29.1% pedunculated and 70.9% non-pedunculated lesions) were included. Overall, 168 (11.2%) patients had post-resection bleeding (8.5 and 2.0% immediate and delayed, respectively), while 15 (1.0%) cases of perforation occurred. Independent predictors of immediate bleeding for pedunculated lesions were bleeding prophylaxis (odds ratio (OR) 0.28, 95% confidence interval (CI) 0.13-0.62), simple polypectomy (versus endoscopic mucosal resection, OR 0.38, 95% CI 0.17-0.88) and inpatient setting (OR 2.21, 95% CI 1.07-5.08), while bleeding prophylaxis (OR 0.37, 95% CI 0.30-0.98), academic setting (OR 0.27, 95% CI 0.12-0.54) and size (OR 1.03, 95% CI 1.00-1.05) were predictors for those non-pedunculated. Indication for colonoscopy (screening versus diagnostic (OR 0.33, 95% CI 0.12-0.86)), antithrombotic therapy (OR 3.12, 95% CI 1.54-6.39) and size (OR 2.34, 95% CI 1.12-4.87) independently predicted delayed bleeding. A low rate of post-resection AEs was observed in a real-life setting, reassuring as to the safety of endoscopic resection of ≥2 cm colorectal lesions. Bleeding prophylaxis reduced the intra-procedural bleeding risk, while antithrombotic therapy increased delayed bleeding.CLINICALTRIAL: (NCT02694120).

CME Exam 4: Clip Closure After Resection of Large Colorectal Lesions With Substantial Risk of Bleeding

CME Exam 4: Clip Closure After Resection of Large Colorectal Lesions With Substantial Risk of Bleeding

166 Is Prophylactic Clipping Necessary After the Resection of Large (≥1 cm) Colorectal Lesions? If So, at What Cost?

INTRODUCTION: Published data on the risk of delayed bleeding (DB) after endoscopic resection of large colorectal lesions (≥1 cm) are conflicting. Prior systematic analyses were underpowered. We systematically reviewed the current data, focusing on randomized studies, to compare the risk of DB with and without clipping, and to determine its cost-effectiveness. We hypothesized that prophylactic clipping is the preferred strategy. METHODS: We conducted a systematic search in PubMed and the Cochrane library to identify RCTs that compared the DB outcomes of prophylactic clipping vs. no clipping after resection of large polyps. We estimated pooled odds ratios (ORs with 95% CIs). Using the 2016 CMS reimbursement rates for procedure and hospitalization and price of clips estimated from the VHA system, we created a decision tree to model the cost: the initial procedure was estimated to be the cost of a colonoscopy with EMR and three clip placement or no clip. We assumed that some patients who had DB required repeat colonoscopy. Our primary outcome is the total cost. We sought to determine the cost of clips that would make the strategies equal. RESULTS: Six studies, which included 2002 patients with 3736 polyps in the clipping arm and 1996 patients with 3717 polyps in the no clipping arm met eligibility criteria for the meta-analysis. Prophylactic clipping of large polyps had a reduced risk of DB compared to those without clipping: OR 0.60 (95% CI: 0.38–0.92) with the random effects and OR 0.59 (95% CI: 0.39–0.89) with the fixed effects models. There was no significant heterogeneity (I2 = 7%, P = 0.37). The pooled risks of bleeding with clipping was 2.3% (95% CI: 0.8–6.1%) and 3.6% (95% CI: 1.2–10.3%) without clipping. In the meta-regression analysis, there was no significant difference based on antithrombotic use (P = 0.57) or lesion size (P = 0.79). Using a base case of 3 clips placed in the clipping arm (cost = $522), we found that the strategy of prophylactic clipping cost $1517.91 compared to $1179.69 for no clipping. The prophylactic clipping strategy cost $11,274 for each rebleed prevented. The two strategies however became equivalent in cost if the total cost of clipping is lower than $183. CONCLUSION: Our analysis suggests that prophylactically clip placement after resection of large (≥1 cm) polyp reduces the risk of DB. Such a strategy is cost-effective if the cost of the clip(s) used is less than $183.

225 Barriers to Endoscopic Mucosal Resection of Large Colorectal Lesions: Results of a Nationwide Survey

INTRODUCTION: Over 90% of complex colon polyps that lack overt features of cancer can be removed using endoscopic mucosal resection (EMR) techniques. EMR is more cost-effective and is associated with less morbidity and mortality than surgery. However, rates of surgical resection have been rising even though extensive evidence suggests endoscopic resection should be first line for the management of complex colon polyps. We aimed to assess perceived barriers towards the utilization of EMR for &gt;2 cm polyps among American endoscopists. METHODS: We administered a 21 question web-based survey with Qualtrics software (Provo, UT, USA). The American College of Gastroenterology distributed the survey to their mailing list on January 24, 2019 and closed it on February 21, 2019. We assessed endoscopist and practice characteristics as well as perceived barriers and facilitators of EMR, and compared responses between providers who performed 0–1 EMR per month with 2 or more EMR per month to determine which barriers and facilitators influence the utilization of EMR. RESULTS: A total of 8,797 practitioners received the survey, with 415 replies (4.7%). Provider demographics are summarized in Table 1. 275 providers (66.7%) reported performing 2 or more EMRs per month. 146 providers (35.1%) felt their fellowship prepared them poorly for large polyp resection. 237 providers (57.1%) felt that the incorporation of EMR training into fellowship would be very beneficial, followed by higher reimbursement (N = 176, 42.4%) and training on EMR technique (N = 154, 37.1%). Providers who performed 1 or fewer EMR per month were significantly more likely to report that lack of structured training, fear of complications, and uncertainty regarding which lesions were amenable to endoscopic management were barriers to routine use of EMR than providers who performed 2 or more EMR per month (Figure 1). They were also more likely to report improved training to be a facilitator for EMR utilization whereas providers who performed 2 or more EMR per month were more likely to report increased reimbursement as a facilitator for EMR utilization (Figure 2). CONCLUSION: We found that endoscopists identified lack of training to be a major barrier to performing EMR, especially for low-volume providers. Increasing reimbursement and training were important potential facilitators identified in our study. Future quality improvement efforts should target these key practice aspects to optimize the endoscopic management of complex colon lesions.

1659 Double Scope Colorectal ESD Using a Gel-Based TAMIS Access Platform

INTRODUCTION: Endoscopic submucosal dissection (ESD) is a promising endoscopic procedure that is increasingly being used for endoscopic resection of large colorectal lesions that may be difficult to remove en-bloc by snare polypectomy. The greatest challenge for ESD remains technical difficulty in achieving optimal traction. In the following report, we discuss the use of Gel-based Transanal Access Platform, typically used for Transanal Minimally Invasive Surgery (TAMIS), being used to facilitate ESD of colorectal lesions by facilitating use of two separate endoscopes simultaneously. CASE DESCRIPTION/METHODS: The procedure was first performed on a patient presenting for resection of a 3 cm × 3 cm rectal lesion. Endoscopic ultrasound was performed and the lesion was classified as T1. A decision was made to perform ESD. A 4 × 4 cm Gel based-TAMIS access device was inserted into the anal canal prior to the start of the procedure. Two access holes were made in the gel cover 2 cm apart with the pre-supplied trocars to allow for the passage of a 1T therapeutic gastroscope and an ultraslim gastroscope. After submucosal injection and circumferential incision, the pediatric forceps were passed through the working channel of the ultraslim scope, and the edge of the lesion was grasped and then manipulated to allow for traction of the lesion. ESD was done using a needle type ESD-knife and resection en-bloc was achieved. There were no complications from the procedure and the patient has no anal pain. Histologic examination demonstrated R0 resection Two additional procedures were carried out on two patients with rectal lesions &gt;2 cm and en-bloc resection was achieved in both cases. Histologic examination in each showed tubulovillous adenoma with high grade dysplasia with clear margins. DISCUSSION: By using a commercially available Transanal Access Platform for the first time in an endoscopic procedure, the endoscopist noted more ease performing ESD. This device allowed the insertion of an additional scope which provided more traction and assisted in resecting each lesion without any reported friction between the two scopes. The set-up of this device is simple and this device appears suitable not only for laparoscopic surgical procedures but also for endoscopic interventions. Further studies are underway to determine the technical success, easy of use, and safety of this dual scope with TAMIS platform technique for colorectal ESD.

Clip Closure After Resection of Large Colorectal Lesions With Substantial Risk of Bleeding

It is not clear whether closure of mucosal defects with clips after colonic endoscopic mucosal resection (EMR) prevents delayed bleeding, although it seems to have no protective effects when risk is low. We performed a randomized trial to evaluate the efficacy of complete clip closure of large (≥2 cm) nonpedunculated colorectal lesions after EMR in patients with an estimated average or high risk of delayed bleeding. We performed a single-blind trial at 11 hospitals in Spain from May 2016 through June 2018, including 235 consecutive patients who underwent EMR for large nonpedunculated colorectal lesions with an average or high risk of delayed bleeding (based on Spanish Endoscopy Society Endoscopic Resection Group score). Participants were randomly assigned to groups that received closure of the scar with 11-mm through-the-scope clips (treated, n= 119) or no clip (control, n= 116). The primary outcome was proportion of patients in each group with delayed bleeding, defined as evident hematochezia that required medical intervention within 15 days after colonoscopy. In the clip group, complete closure was achieved in 68 (57%) cases, with partial closure in 33 (28%) cases and failure to close in 18 (15%) cases. Delayed bleeding occurred in 14 (12.1%) patients in the control group and in 6 (5%) patients in the clip group (absolute risk difference, reduction of 7% in the clip group; 95% confidence interval, -14.7% to 0.3%). After completion of the clip closure, there was only 1 (1.5%) case of delayed bleeding (absolute risk difference, reduction of 10.6%; 95% confidence interval, -4.3% to 17.9%). In a randomized trial of patients with large nonpedunculated colorectal lesions undergoing EMR, we found that clip closure of mucosal defects in patients with a risk of bleeding can be a challenge, but also reduces delayed bleeding. Prevention of delayed bleeding required complete clip closure. ClinicalTrials.gov ID: NCT02765022.

Outcomes of endoscopic resection of large colorectal lesions subjected to prior failed resection or substantial manipulation

PurposeInjudicious attempts at resection and extensive sampling of large colorectal adenomas prior to referral for endoscopic resection (ER) are common. This has deleterious effects, but little is known about the outcomes following ER. We retrospectively analysed the outcomes of ER of large adenomas previously subjected to substantial manipulation.MethodER of large (≥ 2 cm) colorectal adenomas were grouped according to level of manipulation: prior attempted resection, heavy manipulation (≥ six biopsies or tattoo under lesion) or minimal manipulation (< six biopsies). Outcomes were compared between groups. Independent predictors of outcomes were identified using multiple logistic regression.ResultsFive hundred forty-two lesions (mean size 53.7 mm) were included. Two hundred sixty-five (49%) had been subjected to prior attempted resection or heavy manipulation, 151 (28%) to minimal manipulation, and 126 (23%) were not previously manipulated. ESD techniques were used more frequently than EMR after substantial manipulation. There were no differences in initial success of ER (99%, 98%, 98%, p = 0.71). Prior attempted resection was independently associated with recurrence (OR 2.2, 95% CI 1.1–4.5, p = 0.03) and negatively associated with en bloc resection (OR 0.29, 95% CI 0.1–0.7, p = 0.004). Regardless of level of prior manipulation, there were no differences in sustained endoscopic cure with > 95% of patients overall free from recurrence and avoiding surgery at last follow-up.ConclusionThere is a substantial burden of injudicious lesion manipulation before referral, which makes recurrence more likely and en bloc resection less likely. However, with appropriate expertise, sustained successful endoscopic treatment is achievable for the vast majority of patients treated in a specialist unit.

Endoscopic submucosal dissection of 301 large colorectal neoplasias: outcome and learning curve from a specialized center in Europe.

Background and study aims Endoscopic submucosal dissection (ESD) allows en bloc resection of large colorectal lesions but ESD experience is limited outside Asia. This study evaluated implementation of ESD in the treatment of colorectal neoplasia in a Western center. Patients and methods Three hundred and one cases of colorectal ESD (173 rectal and 128 colonic lesions) were retrospectively evaluated in terms of outcome, learning curve and complications. Results Median size was 4 cm (range 1 – 12.5). En bloc resection was achieved in 241 cases amounting to an en bloc resection rate of 80 %. R0 resection was accomplished in 207 cases (69 %), RX and R1 were attained in 83 (27 %) and 11 (4 %) cases, respectively. Median time was 98 min (range 10 – 588) and median proficiency was 7.2 cm 2 /h. Complications occurred in 24 patients (8 %) divided into 12 immediate perforations, five delayed perforations, one immediate bleeding and six delayed bleedings. Six patients (2 %), all with proximal lesions, had emergency surgery. Two hundred and four patients were followed up endoscopically and median follow-up time was 13 months (range 3 – 53) revealing seven recurrences (3 %). En bloc rate improved gradually from 60 % during the first period to 98 % during the last period. ESD proficiency significantly improved between the first study period (3.6 cm 2 /h) and the last study period (10.8 cm 2 /h). Conclusions This study represents the largest material on colorectal ESD in the west and shows that colorectal ESD can be implemented in clinical routine in western countries after appropriate training and achieve a high rate of en bloc and R0 resection with a concomitant low incidence of complications. ESD of proximal colonic lesions should be attempted with caution during the learning curve because of higher risk of complications.

A novel submucosal injection solution for endoscopic resection of large colorectal lesions: a randomized, double-blind trial

SIC-8000 (Eleview) is a new U.S. Food and Drug Administration (FDA)-approved solution for submucosal injection developed to provide a long-lasting cushion to facilitate endoscopic resection maneuvers. Our aim was to compare the efficacy and safety of SIC-8000 with those of saline solution, when performing EMR of large colorectal lesions. In a randomized double-blind trial, patients undergoing EMR for colorectal non-pedunculated lesions≥20mm were randomized in a 1:1 ratio between SIC-8000 and saline solution as control solution in 5 tertiary centers. Endoscopists and patients were blinded to the type of submucosal solution used. Total volume to complete EMR and per lesion size and time of resection were primary endpoints; the Sydney Resection Quotient (SRQ), as well as other EMR outcomes, and the rate of adverse events were secondary endpoints. A 30-day telephone follow-up was performed. An alpha level<0.05 was considered as statistically significant. Of the 327 patients screened, 226 (mean age, 66 ± 10 years; males, 56%) were enrolled in the study and randomized between the 2 submucosal agents. Of these, 211 patients (mean size of the lesions 33 ± 13mm; Paris class Is, 36%; proximal colon, 74%) were entered in the final analysis (SIC-8000, 102; saline solution, 109). EMR was complete in all cases. The total volume needed for EMR was significantly less in the SIC-8000 arm compared with saline group (16.1 ± 9.8 mL vs 31.6 ± 32.0 mL; P< .001). This corresponded to an average volume per lesion size of 0.5 ± 0.3 mL/mm and 0.9 ± 0.6 mL/mm with SIC-8000 and saline solution, respectively (P< .001). The mean time to completely resect the lesion tended to be lower with SIC-8000 than with saline solution (19.1 ± 16.8 minutes vs 29.7 ± 68.9 minutes; P= .1). The SRQ was significantly higher with SIC-8000 compared with saline solution (10.3 ± 8.1 vs 8.0 ± 5.7; P= .04) with a trend for a lower number of resected pieces (5.7 ± 6.0 vs 6.5 ± 5.04; P= .052) and a higher rate of en bloc resections (19/102, 18.6% vs 12/111, 11.0%; P= .1). The rate of adverse events was similar between the 2 arms (SIC-8000, 18.6%; saline solution, 17%), and none of the serious adverse events (SIC-8000, 8.8%; saline solution, 10.7%) were related to the study treatment. In a double-blind, randomized clinical trial, a new FDA-approved agent for sub-mucosal injection appeared to be a more effective and equally safe submucosal agent for EMR injection than saline solution. (Clinical trial registration number: NCT02654418.).