A multicenter, retrospective study of a through-the-needle injection-capable electrosurgical knife for endoscopic submucosal dissection.

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) is a technically challenging resection technique for en-bloc removal of dysplastic and early cancerous gastrointestinal (GI) lesions. We conducted a single-arm retrospective study evaluating the safety and efficacy of a new through-the-needle injection-capable electrosurgical knife used in upper and lower ESD procedures performed at 6 US academic centers. METHODS: Data were retrospectively collected on consecutive cases in which the new ESD knife was used. The primary efficacy endpoint was successful ESD (en bloc resection with negative margins). Secondary efficacy endpoints included en-bloc resection rate, curative resection rate, median ESD time, and median dissection speed. The safety endpoint was device- or procedure-related serious adverse events (SAEs). RESULTS: ESD of 581 lesions in 579 patients were reviewed, including 187 (32.2%) upper GI and 394 (67.8%) lower GI lesions. Prior treatment was reported in 283 (48.9%) patients. Successful ESD was achieved in 477 (82.1% of 581) lesions ‒ lower for patients with versus without submucosal fibrosis (73.6% versus 87.0%, respectively, P < 0.001), but similar for those with versus without previous treatment (81.7% versus 82.3%, respectively, P = 0.848). Four hundred and forty-three (76.2% of 581) lesions met criteria for curative resection. Median ESD time was 1.0 (range 0.1-4.5) hour. Median dissection speed was 17.1 (IQR 5.3-29.8) cm2/hour. Related SAEs were reported in 15 (2.6%) patients, including delayed hemorrhage (1.9%), perforation (0.5%), or postpolypectomy syndrome (0.2%). CONCLUSION: A newly developed through-the-needle injection-capable ESD knife showed a good success rate and excellent safety at US centers. (ClinicalTrials.gov number, NCT04580940).

Safety and efficacy of a novel suturing device for closure of large defects after endoscopic submucosal dissection (with video).

BACKGROUND AND AIMS: Endoscopic suturing enables full closure of large defects after endoscopic submucosal dissection (ESD). However, its use is limited by the need for a double-channel endoscope. A novel closure system, the OverStitch Sx (Apollo Endosurgery, Austin, Tex, USA), compatible with any single-channel endoscope, was introduced to address these shortcomings. The aim of this study was to assess the safety and feasibility of OverStitch Sx for the closure of large defects after ESD. METHODS: This is a prospective single-center feasibility study of patients who underwent closure of large defects after ESD using the OverStitch Sx system. Main outcomes of the study are technical and clinical success, same-day discharge rate, and adverse event rate. RESULTS: Thirty-three patients were enrolled. The mean diameter of included lesions was 5.38 ± 2.52 cm. The defect occupied ≥50% of the lumen circumference in 70% of the cases. En-bloc resection, R0 resection, and curative resection were achieved in 97%, 87.5%, and 78.8% of patients, respectively. Technical success and clinical success were seen in 93.9% and 90.9% of the cases, respectively. Same-day hospital discharge was achieved in 77.4% of patients. Total adverse event rate was 35.7%, including delayed bleeding in 1 patient after rectal ESD that was managed conservatively, self-resolving rectal pain in 7 patients, rectal stricture requiring dilation in 1 patient, and temporary dysphagia in 1 patient. No immediate or delayed perforation was reported. CONCLUSIONS: OverStitch Sx enabled safe and effective closure of large defects after ESD. Future trials are needed to determine its superiority over OverStitch for the closure of defects in challenging locations. (Clinical trial registration number: NCT04361227.).

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.