Implementation of esophageal endoscopic submucosal dissection in Spain: Results from the nationwide registry. / Implementación de la disección endoscópica submucosa esofágica en España: resultados del registro nacional.

INTRODUCTION AND AIMS: The outcomes of endoscopic submucosal dissection (ESD) in the esophagus have not been assessed in our country. Our primary aim was to analyze the effectiveness and safety of the technique. MATERIAL AND METHODS: Analysis of the prospectively maintained national registry of ESD. We included all superficial esophageal lesions removed by ESD in 17 hospitals (20 endoscopists) between January 2016 and December 2021. Subepithelial lesions were excluded. The primary outcome was curative resection. We conducted a survival analysis and used logistic regression analysis to assess predictors of non-curative resection. RESULTS: A total of 102 ESD were performed on 96 patients. The technical success rate was 100% and the percentage of en-bloc resection was 98%. The percentage of R0 and curative resection was 77.5% (n=79; 95%CI: 68%-84%) and 63.7% (n=65; 95%CI: 54%-72%), respectively. The most frequent histology was Barrett-related neoplasia (n=55 [53.9%]). The main reason for non-curative resection was deep submucosal invasion (n=25). The centers with a lower volume of ESD obtained worse results in terms of curative resection. The rate of perforation, delayed bleeding and post-procedural stenosis were 5%, 5% and 15.7%, respectively. No patient died or required surgery due to an adverse effect. After a median follow-up of 14months, 20patients (20.8%) underwent surgery and/or chemoradiotherapy, and 9 patients died (mortality 9.4%). CONCLUSIONS: In Spain, esophageal ESD is curative in approximately two out of three patients, with an acceptable risk of adverse events.

Safety and efficacy of underwater versus conventional endoscopic mucosal resection for colorectal polyps: Systematic review and meta-analysis of RCTs.

Background and study aims Conventional endoscopic mucosal resection (C-EMR) is limited by low en-bloc resection rates, especially for large (> 20 mm) lesions. Underwater EMR (U-EMR) has emerged as an alternative for colorectal polyps and is being shown to improve en-bloc resection rates. We conducted a systematic review and meta-analysis comparing the two techniques. Methods Multiple databases were searched through November 2022 for randomized controlled trials (RCTs) comparing outcomes of U-EMR and C-EMR for colorectal polyps. Meta-analysis was performed to determine pooled proportions and relative risks (RRs) of R0 and en-bloc resection, polyp recurrence, resection time, and adverse events. Results Seven RCTs with 1458 patients (U-EMR: 739, C-EMR: 719) were included. The pooled rate of en-bloc resection was significantly higher with U-EMR vs C-EMR, 70.17% (confidence interval [CI] 46.68-86.34) vs 58.14% (CI 31.59-80.68), respectively, RR 1.21 (CI 1.01-1.44). R0 resection rates were higher with U-EMR vs C-EMR, 58.1% (CI 29.75-81.9) vs 44.6% (CI 17.4-75.4), RR 1.25 (CI 0.99-1.6). For large polyps (> 20 mm), en-bloc resection rates were comparable between the two techniques, RR 1.24 (CI 0.83-1.84). Resection times were comparable between U-EMR and C-EMR, standardized mean difference -1.21 min (CI -2.57 to -0.16). Overall pooled rates of perforation, and immediate and delayed bleeding were comparable between U-EMR and C-EMR. Pooled rate of polyp recurrence at surveillance colonoscopy was significantly lower with U-EMR than with C-EMR, RR 0.62 (CI 0.41-0.94). Conclusions Colorectal U-EMR results in higher en-bloc resection and lower recurrence rates when compared to C-EMR. Both techniques have comparable resection times and safety profiles.

Underwater versus conventional EMR of large nonpedunculated colorectal lesions: a multicenter randomized controlled trial.

BACKGROUND AND AIMS: Underwater EMR (UEMR) is an alternative procedure to conventional EMR (CEMR) to treat large, nonpedunculated colorectal lesions (LNPCLs). In this multicenter, randomized controlled clinical trial, we aimed to compare the efficacy and safety of UEMR versus CEMR on LNPCLs. METHODS: We conducted a multicenter, randomized controlled clinical trial from February 2018 to February 2020 in 11 hospitals in Spain. A total of 298 patients (311 lesions) were randomized to the UEMR (n = 149) and CEMR (n = 162) groups. The main outcome was the lesion recurrence rate in at least 1 follow-up colonoscopy. Secondary outcomes included technical aspects, en bloc resection rate, R0 resection rates, and adverse events, among others. RESULTS: There were no differences in the overall recurrence rate (9.5% UEMR vs 11.7% CEMR; absolute risk difference, -2.2%; 95% CI, -9.4 to 4.9). However, considering polyp sizes between 20 and 30 mm, the recurrence rate was lower for UEMR (3.4% UEMR vs 13.1% CEMR; absolute risk difference, -9.7%; 95% CI, -19.4 to 0). The R0 resection showed the same tendency, with significant differences favoring UEMR only for polyps between 20 and 30 mm. Overall, UEMR was faster and easier to perform than CEMR. Importantly, the techniques were equally safe. CONCLUSIONS: UEMR is a valid alternative to CEMR for treating LNPCLs and could be considered the first option of treatment for lesions between 20 and 30 mm due to its higher en bloc and R0 resection rates. (Clinical trial registration number: NCT03567746.).

Location, morphology and invasiveness of lateral spreading tumors in the colorectum differ between two large cohorts from an eastern and western country.

BACKGROUND AND STUDY AIMS: Data from Japanese series show that surface morphology of laterally spreading tumors (LST) in the colon identifies lesions with different incidence and pattern of submucosal invasion. Such data from western countries are scarce. We compared clinical and histological features of LST in a western country and an eastern country, with special interest on mucosal invasiveness of LST, and investigated the effect of clinical factors on invasiveness in both countries. PATIENTS AND METHODS: Patients with LST lesions ≥20mm were included from a multicenter prospective registry in Spain and from a retrospective registry from the National Cancer Center Hospital East, Japan. The primary outcome was the presence of submucosal invasion in LST. The secondary outcome was the presence of high-risk histology, defined as high-grade dysplasia or submucosal invasion. RESULTS: We evaluated 1102 patients in Spain and 663 in Japan. Morphological and histological characteristics differed. The prevalence of submucosal invasion in Japan was six-fold the prevalence in Spain (Prevalence Ratio PR=5.66; 95%CI: 3.96, 8.08), and the prevalence of high-risk histology was 1.5 higher (PR=1.44; 95%CI: 1.31, 1.58). Compared to the granular homogeneous type and adjusted by clinical features, granular mixed, flat elevated, and pseudo-depressed types were associated with higher odds of submucosal invasion in Japan, whereas only the pseudo-depressed type showed higher risk in Spain. Regarding high-risk histology, both granular mixed and pseudo-depressed were associated with higher odds in Japan, compared with only the granular mixed type in Spain. CONCLUSION: This study reveals differences in location, morphology and invasiveness of LST in an eastern and a western cohort.

Water-assisted colonoscopy: an international modified Delphi review on definitions and practice recommendations.

BACKGROUND AND AIMS: Since 2008, a plethora of research studies has compared the efficacy of water-assisted (aided) colonoscopy (WAC) and underwater resection (UWR) of colorectal lesions with standard colonoscopy. We reviewed and graded the research evidence with potential clinical application. We conducted a modified Delphi consensus among experienced colonoscopists on definitions and practice of water immersion (WI), water exchange (WE), and UWR. METHODS: Major databases were searched to obtain research reports that could potentially shape clinical practice related to WAC and UWR. Pertinent references were graded (Grading of Recommendations, Assessment, Development and Evaluation). Extracted data supporting evidence-based statements were tabulated and provided to respondents. We received responses from 55 (85% surveyed) experienced colonoscopists (37 experts and 18 nonexperts in WAC) from 16 countries in 3 rounds. Voting was conducted anonymously in the second and third round, with ≥80% agreement defined as consensus. We aimed to obtain consensus in all statements. RESULTS: In the first and the second modified Delphi rounds, 20 proposed statements were decreased to 14 and then 11 statements. After the third round, the combined responses from all respondents depicted the consensus in 11 statements (S): definitions of WI (S1) and WE (S2), procedural features (S3-S5), impact on bowel cleanliness (S6), adenoma detection (S7), pain score (S8), and UWR (S9-S11). CONCLUSIONS: The most important consensus statements are that WI and WE are not the same in implementation and outcomes. Because studies that could potentially shape clinical practice of WAC and UWR were chosen for review, this modified Delphi consensus supports recommendations for the use of WAC in clinical practice.

The Answer to "When to Clip" After Colorectal Endoscopic Mucosal Resection Based on a Cost-Effectiveness Analysis.

INTRODUCTION: Delayed bleeding (DB) is the most common major complication of endoscopic mucosal resection (EMR). Two randomized clinical trials recently demonstrated that clip closure after EMR of large nonpedunculated colorectal polyps (LNPCPs) reduces the risk of DB. We analyzed the cost-effectiveness of this prophylactic measure. METHODS: EMRs of LNCPCPs were consecutively registered in the ongoing prospective multicenter database of the Spanish EMR Group from May 2013 until July 2017. Patients were classified according to the Spanish Endoscopy Society EMR group (GSEED-RE2) DB risk score. Cost-effectiveness analysis was performed for both Spanish and US economic contexts. The average incremental cost-effectiveness ratio (ICER) thresholds were set at 54,000 € or $100,000 per quality-adjusted life year, respectively. RESULTS: We registered 2,263 EMRs in 2,130 patients. Applying their respective DB relative risk reductions after clip closure (51% and 59%), the DB rate decreased from 4.5% to 2.2% in the total cohort and from 13.7% to 5.7% in the high risk of the DB GSEED-RE2 subgroup. The ICERs for the universal clipping strategy in Spain and the United States, 469,706 € and $1,258,641, respectively, were not cost effective. By contrast, selective clipping in the high-risk of DB GSEED-RE2 subgroup was cost saving, with a negative ICER of -2,194 € in the Spanish context and cost effective with an ICER of $87,796 in the United States. DISCUSSION: Clip closure after EMR of large colorectal lesions is cost effective in patients with a high risk of bleeding. The GSEED-RE2 DB risk score may be a useful tool to identify that high-risk population.

Clinical validation of risk scoring systems to predict risk of delayed bleeding after EMR of large colorectal lesions.

BACKGROUND AND AIMS: The Endoscopic Resection Group of the Spanish Society of Endoscopy (GSEED-RE) model and the Australian Colonic Endoscopic Resection (ACER) model were proposed to predict delayed bleeding (DB) after EMR of large superficial colorectal lesions, but neither has been validated. We validated and updated these models. METHODS: A multicenter cohort study was performed in patients with nonpedunculated lesions ≥20 mm removed by EMR. We assessed the discrimination and calibration of the GSEED-RE and ACER models. Difficulty performing EMR was subjectively categorized as low, medium, or high. We created a new model, including factors associated with DB in 3 cohort studies. RESULTS: DB occurred in 45 of 1034 EMRs (4.5%); it was associated with proximal location (odds ratio [OR], 2.84; 95% confidence interval [CI], 1.31-6.16), antiplatelet agents (OR, 2.51; 95% CI, .99-6.34) or anticoagulants (OR, 4.54; 95% CI, 2.14-9.63), difficulty of EMR (OR, 3.23; 95% CI, 1.41-7.40), and comorbidity (OR, 2.11; 95% CI, .99-4.47). The GSEED-RE and ACER models did not accurately predict DB. Re-estimation and recalibration yielded acceptable results (GSEED-RE area under the curve [AUC], .64 [95% CI, .54-.74]; ACER AUC, .65 [95% CI, .57-.73]). We used lesion size, proximal location, comorbidity, and antiplatelet or anticoagulant therapy to generate a new model, the GSEED-RE2, which achieved higher AUC values (.69-.73; 95% CI, .59-.80) and exhibited lower susceptibility to changes among datasets. CONCLUSIONS: The updated GSEED-RE and ACER models achieved acceptable prediction levels of DB. The GSEED-RE2 model may achieve better prediction results and could be used to guide the management of patients after validation by other external groups. (Clinical trial registration number: NCT03050333.).

Use of electrosurgical units in the endoscopic resection of gastrointestinal tumors / Empleo de las unidades electroquirúrgicas en la resección endoscópica de neoplasias digestivas

Electrosurgical units (ESUs) are indispensable devices in our endoscopy units. However, many endoscopists are not well-trained on their use and their physical bases are usually not properly studied or understood. In addition, comparative data concerning the settings that may be applied in different circumstances are scarce in the medical literature. Given that it is important to be aware of their strengths and risks, we conducted a review of the available information and research on this topic

Las unidades electroquirúrgicas (UES) son dispositivos indispensables en nuestras unidades de endoscopia. Sin embargo, muchos endoscopistas no están bien entrenados en su uso y sus bases físicas generalmente no son estudiadas o comprendidas adecuadamente. Además, los datos comparativos sobre los ajustes que pueden aplicarse en diferentes circunstancias son escasos en la literatura médica. Dado que es importante conocer sus fortalezas y riesgos, realizamos una revisión de la información existente y la investigación sobre este tema

Use of electrosurgical units in the endoscopic resection of gastrointestinal tumors.

Electrosurgical units (ESUs) are indispensable devices in our endoscopy units. However, many endoscopists are not well-trained on their use and their physical bases are usually not properly studied or understood. In addition, comparative data concerning the settings that may be applied in different circumstances are scarce in the medical literature. Given that it is important to be aware of their strengths and risks, we conducted a review of the available information and research on this topic.

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

BACKGROUND & AIMS: 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. METHODS: 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. RESULTS: 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%). CONCLUSIONS: 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.

Short and long-term outcomes of underwater EMR compared to the traditional procedure in the real clinical practice

Background and aims: underwater endoscopic mucosal resection (U-EMR) has been recently described as an alternative to endoscopic mucosal resection (EMR) for flat colorectal polyps. However, the real applications remain unclear due to the lack of comparative studies. Methods: a multi-centric prospective study was performed from November 2016 to December 2017. All lesions larger than 15 mm that were resected with both techniques were included in the study. The samples were matched using the size, morphology, site and access (SMSA) score as a reference. The efficacy, efficiency and adverse events rates were compared. Results: a total of 162 resections were collected (112 EMR and 50 U-EMR) with an average size of 25 mm. U-EMR achieved better results for the en bloc resection rate (49 vs 62%; p = 0.08) and there were no cases of an incomplete resection (10.7 vs 0%; p = 0.01). U-EMR was faster than EMR and there were no differences in the adverse events rate. Furthermore, U-EMR tended to achieve better results in terms of recurrence. Performing the resection in emersion appeared to prevent the cautery artefact, especially in sessile serrated adenomas. Conclusion: in the real clinical practice, U-EMR and EMR are equivalent in terms of efficacy and safety. Furthermore, U-EMR may be a feasible approach to prevent cautery artefact, allowing an accurate pathologic assessment

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Short and long-term outcomes of underwater EMR compared to the traditional procedure in the real clinical practice.

BACKGROUND AND AIMS: underwater endoscopic mucosal resection (U-EMR) has been recently described as an alternative to endoscopic mucosal resection (EMR) for flat colorectal polyps. However, the real applications remain unclear due to the lack of comparative studies. METHODS: a multi-centric prospective study was performed from November 2016 to December 2017. All lesions larger than 15 mm that were resected with both techniques were included in the study. The samples were matched using the size, morphology, site and access (SMSA) score as a reference. The efficacy, efficiency and adverse events rates were compared. RESULTS: a total of 162 resections were collected (112 EMR and 50 U-EMR) with an average size of 25 mm. U-EMR achieved better results for the en bloc resection rate (49 vs 62%; p = 0.08) and there were no cases of an incomplete resection (10.7 vs 0%; p = 0.01). U-EMR was faster than EMR and there were no differences in the adverse events rate. Furthermore, U-EMR tended to achieve better results in terms of recurrence. Performing the resection in emersion appeared to prevent the cautery artefact, especially in sessile serrated adenomas. CONCLUSION: in the real clinical practice, U-EMR and EMR are equivalent in terms of efficacy and safety. Furthermore, U-EMR may be a feasible approach to prevent cautery artefact, allowing an accurate pathologic assessment.

Endoscopic submucosal hydro-dissection as a rescue treatment of a large recurrent lateral spreading tumor in an ileorectal anastomosis

Background: subtotal colectomy with ileorectal anastomosis (IRA) is currently the most common surgical option in young patients with familial adenomatous polyposis (FAP). However, this surgery does prevent the appearance of lesions in the rectal remnant. In these cases, the endoscopic submucosal dissection might be a feasible option. However, drawbacks such as extreme fibrosis and a difficult maneuverability in the rectal remnant make this technique rather challenging. An ESD by the pocket creation method was planned with the purpose of overcoming these handicaps. Case report: an en-bloq resection of 30 mm of the recurrent adenoma located in rectal remnant of a 42-year-old woman with FAP was successfully achieved following this approach. Two months of follow up endoscopy did not show residual adenomatous tissue. Discussion: in summary, endoscopic submucosal dissection by the pocket creation method allowed a safe and effective dissection and an en-bloc resection of this challenging polyp was achieved

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Endoscopic submucosal hydro-dissection as a rescue treatment of a large recurrent lateral spreading tumor in an ileorectal anastomosis.

BACKGROUND: subtotal colectomy with ileorectal anastomosis (IRA) is currently the most common surgical option in young patients with familial adenomatous polyposis (FAP). However, this surgery does prevent the appearance of lesions in the rectal remnant. In these cases, the endoscopic submucosal dissection might be a feasible option. However, drawbacks such as extreme fibrosis and a difficult maneuverability in the rectal remnant make this technique rather challenging. An ESD by the pocket creation method was planned with the purpose of overcoming these handicaps. CASE REPORT: an en-bloq resection of 30 mm of the recurrent adenoma located in rectal remnant of a 42-year-old woman with FAP was successfully achieved following this approach. Two months of follow up endoscopy did not show residual adenomatous tissue. DISCUSSION: in summary, endoscopic submucosal dissection by the pocket creation method allowed a safe and effective dissection and an en-bloc resection of this challenging polyp was achieved.

Electromagnetic assisted endoscopic submucosal dissection is more efficient than water-jet assisted and conventional ESD in experimental model.

BACKGROUND AND STUDY AIMS: The adequate visualization of the dissection line, inside the submucosal layer, supposes the main challenging issue in ESD. For this reason, several counter traction methods have been developed focused on overcoming this handicap. One of which, Magnetic anchor guided - ESD (MG-ESD) is an attractive alternative. However, the usefulness of this approach has been scarcely assessed and compared with other ESD strategies. Therefore, the aim of this study is to compare three different ESD alternatives in experimental faction. METHODS: This was a prospective non-randomized study, in which three different ESD techniques were performed in an ex-vivo gastric porcine model by an endoscopist slight expertise in ESD: conventional ESD, waterjet assisted ESD and MG-ESD. MG-ESD was performed using two different magnets: inner Neodymiun ringed shape magnet attached to the simulated lesions by an endoclip and external electromagnet connected to a Single Output Adjustable 24V/0.3A Power Supply Unit. RESULTS: Forty-six ESD procedures were performed: 24 conventional ESD, 12 waterjet-assisted ESD and 10 MG-ESD. Average size of the simulated lesions was 33.86 mm. No differences in terms of safety and efficacy were registered between the three approaches. Nevertheless, MG-ESD proved to be faster and more efficient than conventional ESD and water-jet assisted ESD (min per cm 2 10.85 vs. 7.43 vs. 3,41; P  = 0.001). CONCLUSIONS: MG-ESD could be a feasible alternative to conventional ESD even at the beginning of the learning curve. Therefore, researches focused on developing appropriate ESD magnetic devices and further comparative studies must be promoted, in order to assess the reliable usefulness of the magnet-assistance in ESD.

Guía clínica para la resección mucosa endoscópica de lesiones colorrectales no pediculadas / Clinical guidelines for endoscopic mucosal resection of non-pedunculated colorectal lesions

Este documento resume el contenido de la Guía de resección mucosa endoscópica elaborada por el grupo de trabajo de la Sociedad Española de Endoscopia Digestiva (GSEED de Resección Endoscópica) y expone las recomendaciones sobre el manejo endoscópico de las lesiones neoplásicas colorrectales superficiales (AU)

This document summarizes the contents of the Clinical Guidelines for the Endoscopic Mucosal Resection of Non-Pedunculated Colorectal Lesions that was developed by the working group of the Spanish Society of Digestive Endoscopy (GSEED of Endoscopic Resection). This document presents recommendations for the endoscopic management of superficial colorectal neoplastic lesions (AU)

Guía clínica para la resección mucosa endoscópica de lesiones colorrectales no pediculadas / Clinical guidelines for endoscopic mucosal resection of non-pedunculated colorectal lesions

Este documento resume el contenido de la Guía de resección mucosa endoscópica elaborada por el grupo de trabajo de la Sociedad Española de Endoscopia Digestiva (GSEED de Resección Endoscópica) y expone las recomendaciones sobre el manejo endoscópico de las lesiones neoplásicas colorrectales superficiales (AU)

This document summarizes the contents of the Clinical Guidelines for the Endoscopic Mucosal Resection of Non-Pedunculated Colorectal Lesions that was developed by the working group of the Spanish Society of Digestive Endoscopy (GSEED of Endoscopic Resection). This document presents recommendations for the endoscopic management of superficial colorectal neoplastic lesions (AU)