Complete circumferential endoscopic submucosal dissection for early Barrett's neoplasia.

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) is carving out an increasing role in the treatment of esophageal neoplasia in the Western world. Contrary to Asia, most esophageal cancers in North America are associated with Barrett's esophagus. Patients with circumferential advanced neoplasia were previously managed by esophagectomy, but an increased experience with ESD has allowed for an endoscopic alternative. We present our experience with complete circumferential esophageal ESD at a North American referral center. METHODS: All patients undergoing 100% circumferential esophageal ESD between October 2016 and January 2023 at a single tertiary care center in Canada were included in the cohort. Demographics, procedural data, and lesion characteristics are presented in this series. RESULTS: Eleven patients underwent 100% circumferential esophageal ESD during this period for Barrett's neoplasia. All patients had technically successful procedures with en-bloc resection. Nine patients (82%) had R0 resections, defined as clear lateral and deep margins on histologic examination. Two patients had positive deep margins on histologic examination and proceeded to esophagectomy. Seven patients (64%) had adenocarcinoma on the final pathology, of which 6 (86%) had upstaging from their initial biopsy sampling results. The median area of resected specimen was 48 cm2 (interquartile range [IQR], 26-80), and the median procedure time was 231 minutes (IQR, 180-246). Procedural efficiency was 4.0 min/cm2 (IQR, 2.7-5). Two patients (18%) developed refractory strictures after the procedure, which were endoscopically managed to resolution. CONCLUSIONS: Multifocal dysplastic Barrett's esophagus remains a challenging entity to treat. Circumferential ESD is a possible therapeutic option, with high procedural success and a low rate of adverse outcomes. This should be balanced against the risk of stricture development, as the optimal postprocedural prophylaxis regimen is investigated.

Development and initial validation of a video-based peroral endoscopic myotomy assessment tool.

BACKGROUND AND AIMS: Video analysis has emerged as a potential strategy for performance assessment and improvement. We aimed to develop a video-based skill assessment tool for peroral endoscopic myotomy (POEM). METHODS: POEM was deconstructed into basic procedural components through video analysis by an expert panel. A modified Delphi approach and 2 validation exercises were conducted to refine the POEM assessment tool (POEMAT). Twelve assessors used the final POEMAT version to grade 10 videos. Fully crossed generalizability (G) studies investigated the contributions of assessors, endoscopists' performance, and technical elements to reliability. G coefficients below .5 were considered unreliable, between .5 and .7 as modestly reliable, and above .7 as indicative of satisfactory reliability. RESULTS: After task deconstruction, discussions, and the modified Delphi process, the final POEMAT comprised 9 technical elements. G analysis showed low variance for endoscopist performance (.8%-24.9%) and high interrater variability (range, 63.2%-90.1%). The G score was moderately reliable (≥.60) for "submucosal tunneling" and "myotomy" and satisfactorily reliable (≥.70) for "active hemostasis" and "mucosal closure." CONCLUSIONS: We developed and established initial content and response process validity evidence for the POEMAT. Future steps include appraisal of the tool using a wider range of POEM videos to establish and improve the discriminative validity of this tool.

Establishment of Standards for the Referral of Large Non-Pedunculated Colorectal Polyps: An International Expert Consensus Using a Modified Delphi Process.

BACKGROUND AND AIMS: Resection of colorectal polyps has been shown to decrease the incidence and mortality of colorectal cancer. Large non-pedunculated colorectal polyps are often referred to expert centres for endoscopic resection, which requires relevant information to be conveyed to the therapeutic endoscopist to allow for triage and planning of resection technique. The primary objective of our study was to establish minimum expected standards for the referral of LNPCP for potential ER. METHODS: A Delphi methodology was employed to establish consensus on minimum expected standards for the referral of large colorectal polyps among a panel of international endoscopy experts. The expert panel was recruited through purposive sampling, and three rounds of surveys were conducted to achieve consensus, with quantitative and qualitative data analysed for each round. RESULTS: A total of 24 international experts from diverse continents participated in the Delphi study, resulting in consensus on 19 statements related to the referral of large colorectal polyps. The identified factors, including patient demographics, relevant medications, lesion factors, photodocumentation and the presence of a tattoo, were deemed important for conveying the necessary information to therapeutic endoscopists. The mean scores for the statements ranged from 7.04 to 9.29 out of 10, with high percentages of experts considering most statements as a very high priority. Subgroup analysis by continent revealed some variations in consensus rates among experts from different regions. CONCLUSION: The identified consensus statements can aid in improving the triage and planning of resection techniques for large colorectal polyps, ultimately contributing to the reduction of colorectal cancer incidence and mortality.

Endoscopic submucosal dissection (ESD) outcomes in T1B esophageal cancer: a retrospective study.

BACKGROUND AND AIMS: The role of submucosal endoscopic dissection (ESD) in management of invasive esophageal cancer (EC) remains unclear. In this case series, we evaluate the clinical and technical outcomes of patients who underwent ESD with pathologically staged T1b EC. METHODS: This retrospective study included patients who underwent ESD between December 2016 and April 2023 with pathologically staged T1b EC. Patient demographics, tumor characteristics, and ESD technical outcomes were analyzed. Patients were followed to determine disease-free survival and tumor recurrence rates. RESULTS: Sixteen patients with a total of 17 pathologically staged T1b ECs were included in this case series with a median follow-up time of 28 months [range 3-75]. ESD had high en-bloc (100%) and R0 (82.3%) resection rates. 16/17 patients (94.1%) were discharged the same day, and there were no immediate perioperative complications. 4/17 patients (23.5%) had curative ESD resections with no tumor recurrence. Among those with non-curative resections (n = 13), 5 patients had ESD only, 6 had ESD + surgery, and 2 underwent ESD + chemoradiation. In the ESD only group, 2/5 patients (40%) had tumor recurrence. In the ESD + surgery group, one patient died from a surgical complication, and 1/5 (20%) had tumor recurrence at follow-up. There was no tumor recurrence among patients who had ESD + chemoradiation. CONCLUSION: ESD is safe with high en-bloc and R0 resection rates in T1b EC. Recurrence rates are low but patients need close monitoring. Larger-scale studies are needed to determine the long-term clinical efficacy of ESD in T1b EC.

International consensus on the management of large (≥20 mm) colorectal laterally spreading tumors: World Endoscopy Organization Delphi study.

OBJECTIVES: There have been significant advances in the management of large (≥20 mm) laterally spreading tumors (LSTs) or nonpedunculated colorectal polyps; however, there is a lack of clear consensus on the management of these lesions with significant geographic variability especially between Eastern and Western paradigms. We aimed to provide an international consensus to better guide management and attempt to homogenize practices. METHODS: Two experts in interventional endoscopy spearheaded an evidence-based Delphi study on behalf of the World Endoscopy Organization Colorectal Cancer Screening Committee. A steering committee comprising six members devised 51 statements, and 43 experts from 18 countries on six continents participated in a three-round voting process. The Grading of Recommendations, Assessment, Development and Evaluations tool was used to assess evidence quality and recommendation strength. Consensus was defined as ≥80% agreement (strongly agree or agree) on a 5-point Likert scale. RESULTS: Forty-two statements reached consensus after three rounds of voting. Recommendations included: three statements on training and competency; 10 statements on preresection evaluation, including optical diagnosis, classification, and staging of LSTs; 14 statements on endoscopic resection indications and technique, including statements on en bloc and piecemeal resection decision-making; seven statements on postresection evaluation; and eight statements on postresection care. CONCLUSIONS: An international expert consensus based on the current available evidence has been developed to guide the evaluation, resection, and follow-up of LSTs. This may provide guiding principles for the global management of these lesions and standardize current practices.

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.

Safety and effectiveness of peroral endoscopic myotomy in patients on antiplatelet or anticoagulant therapy: an international multicenter case-control study.

BACKGROUND AND AIMS: The risk of bleeding and thromboembolic events in patients undergoing peroral endoscopic myotomy (POEM) who are receiving antithrombotic therapy is unknown. Our primary aim was to assess the safety of POEM in this patient subset. Secondary outcomes were rates of clinical success, GERD, and procedure-related outcomes. METHODS: This was an international, 1:1, case-control study performed at 10 centers using prospectively maintained databases. All consecutive patients who underwent POEM before November 2019 were considered for inclusion. Cases were patients on antiplatelet and/or anticoagulant therapy. Controls not receiving antithrombotics were matched for age and esophageal motility disorder. Primary outcomes were major bleeding and thromboembolic events on postprocedural day 30. RESULTS: Of 2895 patients who underwent POEM, 126 cases (103 on antiplatelets, 35 anticoagulants, 12 both) and 126 controls were enrolled. The rate of major bleeding was higher for the antithrombotics users (5.6% vs 0.8%, P = .03). Anticoagulants and clopidogrel were temporarily interrupted in all cases. Aspirin was continued in 40.5% of users without increasing the bleeding risk. One thromboembolic event occurred in each group (0.79%; P = 1.00). No POEM-related deaths were noted. Rates of clinical success (91.7% vs 96% in controls, P = .20), postprocedural GERD, and technical-related outcomes were similar in both groups. Antithrombotic management was heterogeneous, and guidelines were not adhered to in 23.8% of cases. CONCLUSIONS: POEM is safe and effective in patients receiving antithrombotic therapy although it is associated with a greater risk of major bleeding.

Management of patients after failed peroral endoscopic myotomy: a multicenter study.

BACKGROUND: Although peroral endoscopic myotomy (POEM) is highly effective for the management of achalasia, clinical failures may occur. The optimal management of patients who fail POEM is not well known. This study aimed to compare the outcomes of different management strategies in patients who had failed POEM. METHODS: This was an international multicenter retrospective study at 16 tertiary centers between January 2012 and November 2019. All patients who underwent POEM and experienced persistent or recurrent symptoms (Eckardt score > 3) were included. The primary outcome was to compare the rates of clinical success (Eckardt score ≤ 3) between different management strategies. RESULTS : 99 patients (50 men [50.5 %]; mean age 51.4 [standard deviation (SD) 16.2]) experienced clinical failure during the study period, with a mean (SD) Eckardt score of 5.4 (0.3). A total of 29 patients (32.2 %) were managed conservatively and 70 (71 %) underwent retreatment (repeat POEM 33 [33 %], pneumatic dilation 30 [30 %], and laparoscopic Heller myotomy (LHM) 7 [7.1 %]). During a median follow-up of 10 (interquartile range 3 - 20) months, clinical success was highest in patients who underwent repeat POEM (25 /33 [76 %]; mean [SD] Eckardt score 2.1 [2.1]), followed by pneumatic dilation (18/30 [60 %]; Eckardt score 2.8 [2.3]), and LHM (2/7 [29 %]; Eckardt score 4 [1.8]; P = 0.12). A total of 11 patients in the conservative group (37.9 %; mean Eckardt score 4 [1.8]) achieved clinical success. CONCLUSION : This study comprehensively assessed an international cohort of patients who underwent management of failed POEM. Repeat POEM and pneumatic dilation achieved acceptable clinical success, with excellent safety profiles.

Gastric myotomy length affects severity but not rate of post-procedure reflux: 3-year follow-up of a prospective randomized controlled trial of double-scope per-oral endoscopic myotomy (POEM) for esophageal achalasia.

BACKGROUND: Since Inoue performed the first POEM in 2008, safety and efficacy have been well-established. Early studies focused on refining the technique and avoiding incomplete myotomy. Following the discovery that many patients with abnormal acid exposure are asymptomatic, the focus shifted to post-POEM reflux, but no studies have identified any associated procedural factors. In this study, we examined the intermediate-term results of our previous randomized controlled trial, with particular attention to post-POEM reflux. METHODS: Previously, 100 consecutive patients were randomized to either double- or single-scope POEM. Endoscopy was conducted 2 months post-POEM and annually thereafter. Patients were included in the present study if they completed endoscopy ≥ 6 months post-POEM, and the clinical results of both groups were analyzed with particular attention to clinical efficacy and post-POEM reflux. RESULTS: Median follow-up was 3 years, and most myotomies were performed in the posterior location. The final gastric myotomy length was longer in the double-scope group (3.3 vs. 2.6 cm). Clinical efficacy (≥ 80%) and rates of post-POEM reflux (~ 60%) were similar; however, there was a higher incidence of moderate esophagitis (Los Angeles Grade B) in the double-scope group (25% vs. 4%). There were no cases of severe esophagitis (Los Angeles Grade C/D). Among patients with normal endoscopy at 2 months, > 40% developed erosive esophagitis on intermediate-term follow-up. CONCLUSIONS: This is the first study to demonstrate a procedural factor that increases post-POEM esophagitis. Gastric myotomy > 2.5 cm results in increased rates of moderate esophagitis without improving clinical efficacy. Some patients developed esophagitis in a delayed fashion, emphasizing the importance of ongoing surveillance. We also believe that preserving the gastric sling fibers may help to reduce reflux rates. The double-scope method may help to control myotomy length (2.0-2.5 cm) and direction (lesser curve to avoid the gastric sling) to help maximize clinical efficacy while minimizing post-POEM reflux.

Clinical outcomes of per-oral endoscopic tumor resection for submucosal tumors in the esophagus and gastric cardia.

OBJECTIVES: The clinical success of per-oral endoscopic myotomy (POEM) has led to the development of a new field of 'submucosal endoscopy'. This study aimed to evaluate the safety, efficacy, and limitations of per-oral endoscopic tumor resection (POET) in the management of submucosal tumors (SMTs) in the esophagus and the gastric cardia. METHODS: POET was performed in 47 patients from January 2011 to December 2017. The indication for POET was SMTs ≤ 30 mm in minor axis diameter. Patient and tumor characteristics (age, gender, tumor location, size, and histology), operative and clinical results of POET (procedure time and completion rate, en bloc resection rate, length of hospitalization, adverse events and tumor recurrence) were analyzed retrospectively. RESULTS: POET was successfully completed in 43 patients (91.5%) without any major adverse events (Clavien-Dindo IIIb-IV). Four patients required conversion to an open surgical procedure due to suboptimal visualization during POET. Four patients underwent piecemeal resection of their SMTs including GISTs. Median follow-up was 44 months (10-96 months), during that time, there were no incidences of tumor recurrence. Tumors that had a minor axis diameter > 30 mm or a tumor mass index (TMI) [major axis diameter (mm) × minor axis diameter (mm)] >1000 had a high likelihood of being converted to surgical resection. CONCLUSIONS: POET is a safe and effective treatment for SMTs. However, in patients where the minor axis diameter is > 30 mm or the TMI > 1000, surgical excision should be considered. Furthermore, application of POET for SMTs with malignant potential should be carefully considered to ensure optimal oncologic outcomes.

Gastroesophageal reflux disease after peroral endoscopic myotomy: lest we forget what we already know.

After the performance of the first peroral endoscopic myotomy (POEM) in 2008, POEM has now spread worldwide and has arguably become a first-line treatment option for achalasia. Recently, there is increasing debate regarding post-POEM gastroesophageal reflux (GER) and gastroesophageal reflux disease (GERD). The reported incidences of GERD vary widely, owing to the variability in the definitions used. The literature regarding GERD and achalasia patients with a focus on 24-hour pH testing, esophageal acid exposure, and fermentation and the definitions of GERD used in the POEM literature are examined. 24-hour pH testing in achalasia patients may be abnormal due to fermentation both pre- and post-treatment. It is vital that POEM operators ensure that fermentation is recognized during 24-hour pH testing and excluded in the analysis of acid exposure time (AET) used in the diagnosis of GERD. In untreated achalasia, 24-hour pH testing may suggest abnormal AET in over a third of patients. However, most abnormal AETs in untreated achalasia patients are due to fermentation rather than GER. In treated achalasia, up to half of the patients with abnormal AET may be attributable to fermentation. To have a candid discussion and appropriately address the questions surrounding post-POEM GERD, consistent definitions need to be applied. We suggest the recent definition of GERD from the Lyon Consensus to be utilized when diagnosing GERD in post-POEM patients. Further studies are required in establishing ideal parameters for 24-hour pH testing in achalasia patients.

Peroral endoscopic myotomy (POEM) for complex achalasia and the POEM difficulty score.

BACKGROUND: Peroral endoscopic myotomy (POEM) for achalasia is technically challenging to carry out in patients with type III, multiple prior treatments, prior myotomy, and sigmoid type. Herein, we present a series of consecutive patients with complex achalasia and introduce the POEM difficulty score (PDS). AIM: To demonstrate the application and discuss the utility of PDS and present the feasibility, safety, and efficacy of POEM in complex achalasia patients. METHODS: Forty consecutive POEM were carried out with 28 meeting the criteria for complex achalasia. Primary outcome was clinical success (Eckardt score ≤3) at a minimum of 3 months follow-up. Secondary outcomes included adverse events, procedural velocity and PDS. RESULTS: Twenty-eight complex and 12 non-complex POEM procedures were carried out with 100% and 92% clinical success, respectively, without any major adverse events with a median follow up of 15 months (complex) and 8 months (non-complex). Mean velocities for non-complex, type III, prior myotomy, ≥4 procedures and sigmoid type were as follows: 4.4 ± 1.6, 4.8 ± 1.5, 5.9 ± 2.2, 6.9 ± 2.2 and 8.2 ± 3.2 min/cm, respectively. Median PDS for non-complex, type III, prior myotomy, ≥4 treatments and sigmoid type were 1 (0-3), 2 (0-4), 2.5 (1-6), 3 (2-6) and 3.5 (1-6), respectively. PDS was shown to correlate well with procedural velocity with a correlation coefficient of 0.772 (Spearman's P < 0.001). CONCLUSIONS: PDS identifies the factors that contribute to challenging POEM procedures and correlates well with procedural velocity. The order of increasing difficulty of POEM in complex achalasia appears to be type III, prior myotomy, ≥4 treatments and sigmoid type.

Two penetrating vessels as a novel indicator of the appropriate distal end of peroral endoscopic myotomy.

BACKGROUND AND AIM: One of the challenges during peroral endoscopic myotomy (POEM) is ensuring the appropriate length of myotomy on the gastric side. To determine the appropriate distal end of the gastric myotomy, we focused on the two penetrating vessels (TPVs) found in the gastric cardia during POEM. In the present study, we evaluated whether the TPVs could serve as an accurate indicator of the appropriate distal end of the gastric myotomy. METHODS: All patients who underwent POEM between March and August 2016 were included for this study. When making the submucosal tunnel in the 5 o'clock direction into the stomach, two vessels penetrating through the circular muscle along the edge of oblique muscle in the cardia can be exposed. We designated these two vessels as TPVs. The myotomy was extended until the second TPVs was exposed. The anal end of the submucosal tunnel was confirmed by the double-scope POEM technique, and the length from the gastroesophageal junction to the anal side end of the myotomy was measured by the scale on the endoscope. RESULTS: Among 37 patients who underwent myotomy in the 5 o'clock position, TPVs were found in 34 patients (91.2%). Sufficient submucosal tunneling on the gastric side was confirmed by the double-scope POEM technique in these 34 patients. Median length of the gastric myotomy was 3.0 cm (range 2-4 cm). CONCLUSION: TPVs appears to be a simple and reliable indicator to determine the appropriate distal end of myotomy.

Per-oral endoscopic myotomy, 1000 cases later: pearls, pitfalls, and practical considerations.

BACKGROUND AND AIMS: Eight years have passed since the introduction of the per-oral endoscopy myotomy (POEM) procedure. POEM was initially received as an investigational procedure, but since the revelation of promising safety and efficacy data, it is becoming the preferred treatment for achalasia. With the recent completion of our 1000th POEM procedure, we share our experience and knowledge through the discussion of clinical pearls, pitfalls, and practical considerations. METHODS: The various aspects of the procedure and conditions that warrant special attention are discussed from our perspective, with a focus on areas in which there is currently limited evidence. RESULTS: The key points on patient position, submucosal tunneling, myotomy, closure, intraprocedural bleeding, and advanced sigmoid achalasia are presented. CONCLUSIONS: The dissemination of this information serves as a foundation for new POEM operators and as a catalyst for more-experienced operators to further refine and advance their POEM skills and stimulate international discourse and collaboration.

Double-scope per oral endoscopic myotomy (POEM): a prospective randomized controlled trial.

BACKGROUND: Since its introduction in 2010, per oral endoscopic myotomy (POEM) has offered an alternative to laparoscopic Heller myotomy for the treatment of achalasia. A gastric myotomy length of 3 cm has been recommended; however, it can be difficult to ensure that adequate submucosal dissection has been performed during the procedure. Commonly accepted endoscopic markers of the gastric side can be inaccurate, particularly in patients with prior endoscopic treatments, such as balloon dilation or Botox injection of the lower esophageal sphincter. We hypothesized that the use of a second endoscope would result in a more complete gastric myotomy. METHODS: One hundred consecutive achalasia patients were randomized into single- and double-scope POEM groups. In the treatment group, a second endoscope was used to obtain a retroflexed view of the gastric cardia, while the dissecting scope transilluminated from the end of the submucosal tunnel. Prospectively collected data were analyzed, including myotomy lengths, procedure times, adverse events, and clinical outcomes. RESULTS: POEM was completed with high rates of technical (98-100%) and clinical success (93-97%) in both groups, with a low rate of serious adverse events (2%). The second endoscope resulted in a 17 min increase in procedure time (94 vs. 77 min), myotomy extension in 34% of cases, and an increase in the average gastric myotomy length from 2.6 to 3.2 cm (p = 0.01). CONCLUSION: A second endoscope is useful for ensuring a complete gastric myotomy during POEM. With minimal increase in procedure time and no increase in morbidity, it may be particularly useful in cases of sigmoid esophagus or otherwise altered anatomy that makes identification of the gastroesophageal junction difficult.