Safety and feasibility of same-day discharge after endoscopic submucosal dissection: a Western multicenter prospective cohort study.

BACKGROUND AND AIMS: Recent Western studies support the safety and efficacy of endoscopic submucosal dissection (ESD) for lesions throughout the GI tract. Although admission for observation after ESD is standard in Asia, a more selective approach may optimize resource utilization. We aimed to evaluate the safety and feasibility of same-day discharge (SDD) after ESD and factors associated with admission. METHODS: This was a post hoc analysis of a multicenter, prospective cohort of patients undergoing ESD (2016-2021). The primary end points were safety of SDD and factors associated with post-ESD admission. RESULTS: Of 831 patients (median age, 67 years; 57% male) undergoing 831 ESDs (240 performed in the esophagus, 126 in the stomach, and 465 in the colorectum; median lesion size, 44 mm), 588 (71%) were SDD versus 243 (29%) admissions. Delayed bleeding and perforation occurred in 12 (2%) and 4 (.7%) of SDD patients, respectively; only 1 (.2%) required surgery. Of the 243 admissions, 223 (92%) were discharged after ≤24 hours of observation. Interestingly, larger lesion size (>44 mm) was not associated with higher admission rate (odds ratio [OR], .5; 95% confidence interval [CI], .3-.8; P = .001). Lesions in the upper GI tract versus colon (OR, 1.7; 95% CI, 1.1-2.6; P = .01), invasive cancer (OR, 1.9; 95% CI, 1.2-3.1; P = .01), and adverse events (OR, 2.7; 95% CI, 1.5-4.8; P = .001) were independent factors for admission. Admissions were more likely performed by endoscopists with ESD volume <50 cases (OR, 2.1; 95% CI, 1.3-3.3; P = .001) with procedure time >75 minutes (OR, 13.5; 95% CI, 8.5-21.3; P < .0001). CONCLUSIONS: SDD after ESD can be safe and feasible. Patients with invasive cancer, lesions in the upper GI tract, longer procedure times, or procedures performed by low-volume ESD endoscopists are more likely to be admitted postprocedure. Risk stratification of patients for SDD after ESD should help optimize resource utilization and enhance ESD uptake in the West. (Clinical trial registration number: NCT02989818.).

Clip Closure Does Not Reduce Risk of Bleeding After Resection of Large Serrated Polyps: Results From a Randomized Trial.

BACKGROUND & AIMS: Serrated polyps are important colorectal cancer precursors and are most commonly located in the proximal colon, where post-polypectomy bleeding rates are higher. There is limited clinical trial evidence to guide best practices for resection of large serrated polyps (LSPs). METHODS: In a multicenter trial, patients with large (≥20 mm) non-pedunculated polyps undergoing endoscopic mucosal resection (EMR) were randomized to clipping of the resection base or no clipping. This analysis is stratified by histologic subtype of study polyp(s), categorized as serrated [sessile serrated lesions (SSLs) or hyperplastic polyps (HPs)] or adenomatous, comparing clip vs control groups. The primary outcome was severe post-procedure bleeding within 30 days of colonoscopy. RESULTS: A total of 179 participants with 199 LSPs (191 SSLs and 8 HPs) and 730 participants with 771 adenomatous polyps were included in the study. Overall, 5 patients with LSPs (2.8%) experienced post-procedure bleeding compared with 42 (5.8%) of those with adenomas. There was no difference in post-procedure bleeding rates between patients in the clip vs control group among those with LSPs (2.3% vs 3.3%, respectively, difference 1.0%; P = NS). However, among those with adenomatous polyps, clipping was associated with a lower risk of post-procedure bleeding (3.9% vs 7.6%, difference 3.7%; P = .03) and overall serious adverse events (5.5% vs 10.6%, difference 5.1%; P = .01). CONCLUSION: The post-procedure bleeding risk for LSPs removed via EMR is low, and there is no discernable benefit of prophylactic clipping of the resection base in this group. This study indicates that the benefit of endoscopic clipping following EMR may be specific for >2 cm adenomatous polyps located in the proximal colon. CLINICALTRIALS: gov, Number: NCT01936948.

Effect of endoscopic submucosal dissection on histologic diagnosis in Barrett's esophagus visible neoplasia.

BACKGROUND AND AIMS: Data are limited on the role of endoscopic submucosal dissection (ESD) as a potential diagnostic and staging tool in Barrett's esophagus (BE) neoplasia. We aimed to evaluate the frequency and factors associated with change of histologic diagnosis by ESD compared with pre-ESD histology. METHODS: This was a multicenter, prospective cohort study of patients who underwent ESD for BE visible neoplasia. A change in histologic diagnosis was defined as "upstaged" or "downstaged" if the ESD specimen had a higher or lower degree, respectively, of dysplasia or neoplasia when compared with pre-ESD specimens. RESULTS: Two hundred five patients (median age, 69 years; 81% men) with BE visible neoplasia underwent ESD from 2016 to 2021. Baseline histology was obtained using forceps (n = 182) or EMR (n = 23). ESD changed the histologic diagnosis in 55.1% of cases (113/205), of which 68.1% were upstaged and 31.9% downstaged. The frequency of change in diagnosis after ESD was similar whether baseline histology was obtained using forceps (55.5%) or EMR (52.2%) (P = .83). In aggregate, 23.9% of cases (49/205) were upstaged to invasive cancer on ESD histopathology. On multivariate analysis, lesions in the distal esophagus and gastroesophageal junction (odds ratio, 2.1; 95 confidence interval, 1.1-3.9; P = .02) and prior radiofrequency ablation (odds ratio, 2.5; 95% confidence interval, 1.2-5.5; P = .02) were predictors of change in histologic diagnosis. CONCLUSIONS: ESD led to a change of diagnosis in more than half of patients with BE visible neoplasia. Selective ESD can serve as a potential diagnostic and staging tool, particularly in those with suspected invasive disease. (Clinical trial registration number: NCT02989818.).

Endoscopic Submucosal Dissection in North America: A Large Prospective Multicenter Study.

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) in Asia has been shown to be superior to endoscopic mucosal resection (EMR) and surgery for the management of selected early gastrointestinal cancers. We aimed to evaluate technical outcomes of ESD in North America. METHODS: We conducted a multicenter prospective study on ESD across 10 centers in the United States and Canada between April 2016 and April 2020. End points included rates of en bloc resection, R0 resection, curative resection, adverse events, factors associated with failed resection, and recurrence post-R0 resection. RESULTS: Six hundred and ninety-two patients (median age, 66 years; 57.8% were men) underwent ESD (median lesion size, 40 mm; interquartile range, 25-52 mm) for lesions in the esophagus (n = 181), stomach (n = 101), duodenum (n = 11), colon (n = 211) and rectum (n = 188). En bloc, R0, and curative resection rates were 91.5%, 84.2%, and 78.3%, respectively. Bleeding and perforation were reported in 2.3% and 2.9% of the cases, respectively. Only 1 patient (0.14%) required surgery for adverse events. On multivariable analysis, severe submucosal fibrosis was associated with failed en bloc, R0, and curative resection and higher risk for adverse events. Overall recurrence was 5.8% (31 of 532) at a mean follow-up of 13.3 months (range, 1-60 months). CONCLUSIONS: In this large multicenter prospective North American experience, we demonstrate that ESD can be performed safely, effectively, and is associated with a low recurrence rate. The technical resection outcomes achieved in this study are in line with the current established consensus quality parameters and further support the implementation of ESD for the treatment of select gastrointestinal neoplasms; ClinicalTrials.gov, Number: NCT02989818.

Efficacy of Endoscopic Submucosal Dissection for Superficial Gastric Neoplasia in a Large Cohort in North America.

BACKGROUND & AIMS: Endoscopic submucosal dissection (ESD) is a widely accepted treatment option for superficial gastric neoplasia in Asia, but there are few data on outcomes of gastric ESD from North America. We aimed to evaluate the safety and efficacy of gastric ESD in North America. METHODS: We analyzed data from 347 patients who underwent gastric ESD at 25 centers, from 2010 through 2019. We collected data on patient demographics, lesion characteristics, procedure details and related adverse events, treatment outcomes, local recurrence, and vital status at the last follow up. For the 277 patients with available follow-up data, the median interval between initial ESD and last clinical or endoscopic evaluation was 364 days. The primary endpoint was the rate of en bloc and R0 resection. Secondary outcomes included curative resection, rates of adverse events and recurrence, and gastric cancer-related death. RESULTS: Ninety patients (26%) had low-grade adenomas or dysplasia, 82 patients (24%) had high-grade dysplasia, 139 patients (40%) had early gastric cancer, and 36 patients (10%) had neuroendocrine tumors. Proportions of en bloc and R0 resection for all lesions were 92%/82%, for early gastric cancers were 94%/75%, for adenomas and low-grade dysplasia were 93%/ 92%, for high-grade dysplasia were 89%/ 87%, and for neuroendocrine tumors were 92%/75%. Intraprocedural perforation occurred in 6.6% of patients; 82% of these were treated successfully with endoscopic therapy. Delayed bleeding occurred in 2.6% of patients. No delayed perforation or procedure-related deaths were observed. There were local recurrences in 3.9% of cases; all occurred after non-curative ESD resection. Metachronous lesions were identified in 14 patients (6.9%). One of 277 patients with clinical follow up died of metachronous gastric cancer that occurred 2.5 years after the initial ESD. CONCLUSIONS: ESD is a highly effective treatment for superficial gastric neoplasia and should be considered as a viable option for patients in North America. The risk of local recurrence is low and occurs exclusively after non-curative resection. Careful endoscopic surveillance is necessary to identify and treat metachronous lesions.

Factors associated with complete clip closure after endoscopic mucosal resection of large colorectal polyps.

BACKGROUND AND STUDY AIM : Delayed bleeding is a common adverse event following endoscopic mucosal resection (EMR) of large colorectal polyps. Prophylactic clip closure of the mucosal defect after EMR of nonpedunculated polyps larger than 20 mm reduces the incidence of severe delayed bleeding, especially in proximal polyps. This study aimed to evaluate factors associated with complete prophylactic clip closure of the mucosal defect after EMR of large polyps. METHODS : This is a post hoc analysis of the CLIP study (NCT01936948). All patients randomized to the clip group were included. Main outcome was complete clip closure of the mucosal resection defect. The defect was considered completely closed when no remaining mucosal defect was visible and clips were less than 1 cm apart. Factors associated with complete closure were evaluated in multivariable analysis. RESULTS : In total, 458 patients (age 65, 58 % men) with 494 large polyps were included. Complete clip closure of the resection defect was achieved for 338 polyps (68.4 %); closure was not complete for 156 (31.6 %). Factors associated with complete closure in adjusted analysis were smaller polyp size (odds ratio 1.06 for every millimeter decrease [95 % confidence interval 1.02-1.08]), good access (OR 3.58 [1.94-9.59]), complete submucosal lifting (OR 2.28 [1.36-3.90]), en bloc resection (OR 5.75 [1.48-22.39]), and serrated histology (OR 2.74 [1.35-5.56]). CONCLUSIONS : Complete clip closure was not achieved for almost one in three resected large nonpedunculated polyps. While stable access and en bloc resection facilitate clip closure, most factors associated with clip closure are not modifiable. This highlights the need for alternative closure options and measures to prevent bleeding.

Full-thickness resection device (FTRD) for treatment of upper gastrointestinal tract lesions: the first international experience.

Background and study aims The Full-Thickness Resection Device (FTRD) provides a novel treatment option for lesions not amenable to conventional endoscopic resection techniques. There are limited data on the efficacy and safety of FTRD for resection of upper gastrointestinal tract (GIT) lesions. Patients and methods This was an international multicenter retrospective study, including patients who had an endoscopic resection of an upper GIT lesion using the FTRD between January 2017 and February 2019. Results Fifty-six patients from 13 centers were included. The most common lesions were mesenchymal neoplasms (n = 23, 41 %), adenomas (n = 7, 13 %), and hamartomas (n = 6, 11 %). Eighty-four percent of lesions were located in the stomach, and 14 % in the duodenum. The average size of lesions was 14 mm (range 3 to 33 mm). Deployment of the FTRD was technically successful in 93 % of patients (n = 52) leading to complete and partial resection in 43 (77 %) and 9 (16 %) patients, respectively. Overall, the FTRD led to negative histological margins (R0 resection) in 38 (68 %) of patients. A total of 12 (21 %) mild or moderate adverse events (AEs) were reported. Follow-up endoscopy was performed in 31 patients (55 %), on average 88 days after the procedure (IQR 68-138 days). Of these, 30 patients (97 %) did not have any residual or recurrent lesion on endoscopic examination and biopsy, with residual adenoma in one patient (3 %). Conclusions Our results suggest a high technical success rate and an acceptable histologically complete resection rate, with a low risk of AEs and early recurrence for FTRD resection of upper GIT lesions.

Effects of Blended (Yellow) vs Forced Coagulation (Blue) Currents on Adverse Events, Complete Resection, or Polyp Recurrence After Polypectomy in a Large Randomized Trial.

BACKGROUND & AIMS: There is debate over the type of electrosurgical setting that should be used for polyp resection. Some endoscopists use a type of blended current (yellow), whereas others prefer coagulation (blue). We performed a single-blinded, randomized trial to determine whether type of electrosurgical setting affects risk of adverse events or recurrence. METHODS: Patients undergoing endoscopic mucosal resection of nonpedunculated colorectal polyps 20 mm or larger (n = 928) were randomly assigned, in a 2 × 2 design, to groups that received clip closure or no clip closure of the resection defect (primary intervention) and then to either a blended current (Endocut Q) or coagulation current (forced coagulation) (Erbe Inc) (secondary intervention and focus of the study). The study was performed at multiple centers, from April 2013 through October 2017. Patients were evaluated 30 days after the procedure (n = 919), and 675 patients underwent a surveillance colonoscopy at a median of 6 months after the procedure. The primary outcome was any severe adverse event in a per patient analysis. Secondary outcomes were complete resection and recurrence at first surveillance colonoscopy in a per polyp analysis. RESULTS: Serious adverse events occurred in 7.2% of patients in the Endocut group and 7.9% of patients in the forced coagulation group, with no significant differences in the occurrence of types of events. There were no significant differences between groups in proportions of polyps that were completely removed (96% in the Endocut group vs 95% in the forced coagulation group) or the proportion of polyps found to have recurred at surveillance colonoscopy (17% and 17%, respectively). Procedural characteristics were comparable, except that 17% of patients in the Endocut group had immediate bleeding that required an intervention, compared with 11% in the forced coagulation group (P = .006). CONCLUSIONS: In a randomized trial to compare 2 commonly used electrosurgical settings for the resection of large colorectal polyps (Endocut vs forced coagulation), we found no difference in risk of serious adverse events, complete resection rate, or polyp recurrence. Electrosurgical settings can therefore be selected based on endoscopist expertise and preference. Clinicaltrials.gov ID NCT01936948.

EUS-guided gastroenteric anastomosis as a bridge to definitive treatment in benign gastric outlet obstruction.

BACKGROUND AND AIMS: Benign gastric outlet obstruction (GOO) has typically been managed surgically. However, many patients are poor operative candidates because of comorbidities. EUS-guided gastroenterostomy (EUS-GE) using lumen-apposing metal stents (LAMSs) has previously demonstrated efficacy as a definitive treatment for benign and malignant GOO; however, limited data exist on use as a bridge to resolution of the obstruction in an attempt to avoid or delay definitive surgery. METHODS: A retrospective series of consecutive patients who underwent EUS-GE between January 2013 and July 2019 for benign GOO at a tertiary referral center were included in the study. The primary outcome was the rate of definitive surgery; secondary outcomes included technical success and rate of adverse events. RESULTS: During the study period, 22 patients with benign GOO underwent EUS-GE (40% female; mean age, 54.2 years). The mean procedure time was 66 minutes, and technical success was achieved in 21. Five patients developed recurrent GOO while the LAMS was in place after a mean dwell time of 228 days; 1 patient was converted to surgical GE. LAMSs were removed electively in 18 patients after GOO resolution and a mean dwell time of 270 days; 1 patient developed a recurrent GOO after LAMS removal and was converted to surgical GE. The rate of recurrent GOO after LAMS removal was 5.6%. Three severe adverse events occurred in the cohort. CONCLUSIONS: EUS-GE was able to prevent surgery for GOO in 83.3% of cases. LAMSs needed to stay in place for a mean of 8.5 months to allow resolution of GOO, and there was a low rate of recurrent GOO (5.6%) after LAMS removal. Prospective, randomized trials comparing surgical and endoscopic anastomoses are needed in patients with benign causes of GOO.

Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial.

BACKGROUND & AIMS: Bleeding is the most common severe complication after endoscopic mucosal resection of large colon polyps and is associated with significant morbidity and cost. We examined whether prophylactic closure of the mucosal defect with hemoclips after polyp resection reduces the risk of bleeding. METHODS: We performed a multicenter, randomized trial of patients with a large nonpedunculated colon polyp (≥20 mm) at 18 medical centers in North America and Spain from April 2013 through October 2017. Patients were randomly assigned to groups that underwent endoscopic closure with a clip (clip group) or no closure (control group) and followed. The primary outcome, postprocedure bleeding, was defined as a severe bleeding event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. Subgroup analyses included postprocedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event. RESULTS: A total of 919 patients were randomly assigned to groups and completed follow-up. Postprocedure bleeding occurred in 3.5% of patients in the clip group and 7.1% in the control group (absolute risk difference [ARD] 3.6%; 95% confidence interval [CI] 0.7%-6.5%). Among 615 patients (66.9%) with a proximal large polyp, the risk of bleeding in the clip group was 3.3% and in the control group was 9.6% (ARD 6.3%; 95% CI 2.5%-10.1%); among patients with a distal large polyp, the risks were 4.0% in the clip group and 1.4% in the control group (ARD -2.6%; 95% CI -6.3% to -1.1%). The effect of clip closure was independent of antithrombotic medications or polyp size. Serious adverse events occurred in 4.8% of patients in the clip group and 9.5% of patients in the control group (ARD 4.6%; 95% CI 1.3%-8.0%). CONCLUSIONS: In a randomized trial, we found that endoscopic clip closure of the mucosal defect following resection of large colon polyps reduces risk of postprocedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon. ClinicalTrials.gov no: NCT01936948.

Long-term outcomes of endoscopic submucosal dissection versus surgery in early gastric cancer: a systematic review and meta-analysis.

Endoscopic submucosal dissection (ESD) and gastrectomy with lymph node dissection are considered acceptable treatment modalities for early gastric cancer (EGC). In the last decade, ESD has become more favorable than surgery as it offers faster recovery, lower costs, and a superior quality of life when compared to gastrectomy. The aim of this study is to compare the long-term outcome of ESD versus surgery in EGC. We performed a systematic and comprehensive search of major reference databases (Medline, Embase, CINHAL) for all studies that compared the outcome of EGC for patients underwent ESD or surgery in the same cohort. A systematic review was conducted through November 2017, using pooled analysis to calculate 5-year overall survival (OS) rate, disease-specific survival (DSS) rate, disease-free survival (DFS) rate, and recurrence-free survival (RFS) rate of ESD versus gastrectomy. Five-year OS and DSS were similar between ESD and gastrectomy groups 96 versus 96% and 99.4 versus 99.2%, respectively. Likewise, DFS was similar in both groups 95.9 versus 98.5% odds ratio 1.86 (0.57-6.0) P=0.3. However, ESD had a lower RFS compared to surgery 92.4 versus 98.3% odds ratio 0.17 (0.1-4.9) P=0.001. Overall, there was a higher recurrence rate in patients who underwent ESD compared to surgery [40/2943 (1.4%) vs. 12/3116 (0.4) risk ratio (RR) 2.5 (1.3-4.8) P=0.005]. Moreover, synchronous and metachronous cancers were more prevalent in the ESD group compared to the surgery group [1.5 vs. 0.1% RR 5.7 (1.5-21.9) P=0.01] [16/1082 (1.5%) vs. 1/1485 (0.1%) RR 10.1 (5.9-17.1) P=0.0001]. Five-year OS, DSS and DFS were similar between ESD and surgery groups. However, recurrent, synchronous and metachronous cancers were more prevalent in patients treated by ESD compared to patients treated by surgery, resulting in a lower RFS. Adequate surveillance with upper endoscopy is crucial after ESD to detect early recurrence and metachronous lesions.

The incidence of lymph node metastasis in submucosal early gastric cancer according to the expanded criteria: a systematic review.

BACKGROUND: For successful endoscopic treatment of early gastric cancer (EGC), absolute criteria for a curative en bloc resection were initially established to include predominantly differentiated mucosal lesions ≤ 2 cm in diameter without ulceration. These indications were subsequently expanded to include larger, ulcerated, and predominantly undifferentiated mucosal lesions. In addition, differentiated type adenocarcinomas ≤ 3 cm with slight submucosal invasion of < 500 µm (pT1b1) are regarded as "curative" under the expanded criteria. However, data derived from studies of surgical specimens in patients with pT1b1 EGC have yielded varying rates of lymph node metastasis (LNM). METHOD: A systemic review was conducted using the pooled analysis to calculate the incidence of LNM in pT1b1 EGC, and to investigate whether using a cut-off value of < 300 µm would decrease the risk of LNM in patients with submucosal EGC. RESULTS: Nineteen articles were included. 1507 patients with pT1b1 EGC met the expanded indications. The incidence of LNM was 3% (45 out of 1507 patients). In a subgroup analysis of three studies, there was no significant difference in the LNM between pT1b EGC < 300 µm and < 500 µm [3/121(2.5%) vs. 5/180 (2.8%)] (OR 0.89, 95% CI 0.22-3.54). CONCLUSION: Overall, expanding the indications for endoscopic resection of EGC to include lesions ≤ 3 cm T1b1 is associated with a potential risk of LNM of 3%. In countries outside of Japan, we found a slightly higher risk of LNM (4.0%). These estimates of LNM should be incorporated into decisions regarding further management of patients with EGC ≤ 3 cm who are found to have slight submucosal invasion (< 500 µm) in an ESD specimen. Standardization of specimen handling and histological evaluation is essential if the Japanese results of endoscopic treatment for EGC are to be successfully applied in other parts of the world.

POEM for Achalasia.

In 2008, a new treatment modality for esophageal achalasia was introduced-peroral endoscopic myotomy (POEM). POEM is a procedure performed endoscopically, which allows transection of the muscular fibers of the distal esophagus and of the lower esophageal sphincter. The procedure is therefore similar to a laparoscopic Heller myotomy without a fundoplication. Short-term studies have shown that POEM is very effective in relieving dysphagia and regurgitation, but concerns have been raised about the incidence of post-POEM gastroesophageal reflux. Prospective and randomized trials will be needed to determine the role of this new procedure in the treatment algorithm of esophageal achalasia.