AbstractObjectivesEndoscopic closures of mucosal defects following endoscopic resection can be challenging and time‐consuming. The novel through‐the‐scope suture device has demonstrated acceptable closure times, but its learning curve is still unknown. This study aims to evaluate the number of cases required to achieve competency in this device.MethodsTwo endoscopists participated; a novice with less than 400 experiences in upper gastrointestinal endoscopy and an expert with over 500 experiences in endoscopic submucosal dissection. Neither endoscopist had previous exposure to the device. In four porcine models, 24 gastric mucosal defects, each 2–4 cm in diameter, were created by endoscopic mucosal resection with ligation. Each endoscopist performed endoscopic closure for 12 mucosal defects with a single through‐the‐scope suture device per lesion. The primary endpoint was the number of cases needed to reach competency, defined as achieving a procedure time below the average closure time reported in the literature. Secondary endpoints included procedure time, complete closure success rates, and incidence of adverse events.ResultsThe mean defect size was 2.9 (±0.2) cm. Competency was achieved after six cases in the expert and seven cases in the novice. The median closure time was 9.0 (interquartile range [IQR]: 6.0–11.0) min for the expert and 8.0 (IQR: 6.2–9.7) min for the novice (p = 0.862). Complete closure success rates were 75.0% (n = 9) for the expert and 83.3% (n = 10) for the novice. No adverse events were reported.ConclusionsA small number of cases were required for both expert and novice endoscopists to reach competency in the novel through‐the‐scope suture device.

Closure of mucosal defects following colorectal endoscopic submucosal dissection (C‐ESD) is often performed to prevent post‐C‐ESD adverse events. However, large mucosal defect closure using conventional clips remains technically challenging. Here, we evaluated the feasibility of the novel endoclip with anchor prongs, called the MANTIS Clip (Boston Scientific, Tokyo, Japan), for mucosal defect closure after C‐ESD. This high‐volume retrospective study was conducted at a single center. From March until December 2023, consecutive patients who underwent post‐C‐ESD mucosal defect closure using MANTIS Clip to achieve complete closure were enrolled. Patient clinical characteristics and outcomes were evaluated. Closure of the mucosal defect using the MANTIS Clip was attempted following C‐ESD in 32 lesions. The median sizes of the resection specimens and the tumors were 32 mm (range, 17–100 mm) and 23.5 mm (range, 5–96 mm), respectively. The lesions were distributed between the cecum, ascending, transverse, descending, sigmoid, and rectum. Complete closure was achieved in 96.9% of cases (31/32). All lesions up to 61 mm in defect size were completely closed. The median closure time was 7.9 (range, 3.3–18.0) min. The median numbers of MANTIS Clip and additional conventional clips were 3 (range, 1–4) and 5 (range, 1–11), respectively. No adverse events associated with closure, post‐ESD bleeding, and delayed perforation occurred. MANTIS Clip closure for large post‐C‐ESD mucosal defects was found to be feasible and reliable with a high complete closure rate and a short procedure time.

This study aimed to evaluate the diagnostic utility of the ultra-thin endoscope (UTE) for superficial squamous cell carcinoma (SSCC) compared to magnifying endoscopy (ME) under narrow-band imaging. Participants underwent endoscopic examination, and images of pharyngeal and esophageal SCCs, as along with suspicious SSCC lesions, were collected using UTE and ME on the same day. Three image catalogs (UTE, ME-1, and ME-2) were created and reviewed by three expert endoscopists. ME-1 and ME-2 contained the same endoscopic images. The primary endpoint was the intra-observer agreement for diagnosing SCC. Eighty-six lesions (SCC = thirty-nine, non-SCC = forty-seven) in 43 participants were identified. The kappa values for the intra-observer agreement between UTE and ME-1 vs. the control (ME-1 vs. ME-2) were 0.74 vs. 0.84, 0.63 vs. 0.76, and 0.79 vs. 0.88, respectively. The accuracies for diagnosing SCC by UTE and ME-1 were 87.2% vs. 86.0%, 78.0% vs. 73,2%, and 75.6 vs. 82.6%, respectively, with no significant differences (p > 0.05). The rates of lesions that were diagnosed with confidence by UTE and ME-1 were 30.2% vs. 27.9%, 55.8% vs. 62.8%, and 58.1% vs. 55.8%, respectively. UTE demonstrates substantial diagnostic performance for SSCC in the pharynx and esophagus.

A series of traction devices have been developed to provide an additional hand for endoscopists to manipulate the mucosal overlay away from the surgical plane and accelerate electrosurgical dissection by creating optimal tissue tensions to facilitate endoscopic submucosal dissection (ESD). In the 2000s and the early 2010s, both device-independent and device-dependent traction techniques were meticulously explored, mainly in Japanese institutions.1 Regardless of operator preference, optimal use of a hood attachment and device-independent techniques – such as gravitational traction, the creation of a mucosal flap, and submucosal pocket and tunnel – would be strongly recommended as standard techniques to facilitate ESD. The S–O clip (Zeoclip; Zeon Medical, Tokyo, Japan), clip-with-thread, and dental floss methods are the most widely tested device-dependent techniques in clinical settings, including randomized controlled trials (RCTs). Meanwhile, the advantages of device-dependent techniques can be limited to selective occasions or cases. Traction devices may counterintuitively hinder the surgical view, interfere with the maneuvering of surgical tools and an endoscope, and may eventually give rise to an inadvertent incision into the muscular layer. Thus, RCTs for device-dependent techniques have been conducted to compare the procedure time and safety of ESD with and without traction device assistance throughout the operation. We congratulate Ichijima et al. for their great effort completing the CONNECT-C study, the first multicenter, nonblinded RCT to test the efficacy of traction devices in patients with a superficial colorectal lesion.2 Two multicenter CONNECT studies for other locations were previously reported prior to the CONNECT-C trial. The CONNECT-G study3 for early gastric neoplasms did not find a significant difference between the traction and conventional groups (60.7 vs. 58.1 min, P = 0.45), but a subset analysis showed that lesions in the greater curvature of the upper and middle portions of the stomach resulted in shorter mean procedure time (104.1 vs. 57.2 min, P = 0.01). Conversely, the CONNECT-E study4 for esophageal cancer also showed a significantly shorter ESD procedure time for traction-assisted ESD than for conventional ESD (45.5 vs. 60.5 min, P < 0.001). The results of a series of CONNECT studies imply that the advantage of evaluated traction techniques can vary widely according to the anatomical location of the lesions. Two other RCTs on colorectal lesions have been reported, and both found favorable outcomes for traction-assisted ESD. In 2014, Ritsuno et al. reported an RCT of a total of 70 participants with a superficial colorectal tumor of ≥20 mm in diameter.5 The S–O clip-assisted ESD group had a significantly shorter mean procedure time compared to the conventional ESD group (37.4 ± 32.6 vs. 67.1 ± 44.1 min, P = 0.03). In 2018, Yamasaki et al. reported a similar RCT analyzing a total of 84 patients to evaluate whether the originally developed clip-with-thread method would facilitate colorectal ESD.6 A significantly shorter mean procedure time was observed in the traction group (40 vs. 70 min, P < 0.00001). However, these trials were single-center and lacked an external validity assessment. The CONNECT-C study was conducted at 10 facilities in Japan, assigning 123 patients to the traction ESD group and 128 to the conventional ESD group. In this study, the S–O clip-assisted, traction-assisted, or modified dental floss clip method was chosen according to the operator's discretion. The primary outcome did not show a significant difference in the median procedure time between the two groups (61 vs. 53 min, P = 0.18). Unavoidable performance bias exists in nonblinded trials, and there is a tendency to show better results for the treatment of interest. The negative results of this study could be partially explained by the hypothesis that a multicenter study involving operators with varied backgrounds and expertise might reduce performance bias. Many operators might not appreciate the assistance of traction devices as well as operators in the preceding single-center RCTs, who should be more familiar with a specific traction device. The authors also inferred that the lower risk of intraoperative bleeding and the higher effectiveness of device-independent traction techniques in colorectal areas could lead to the negligible effect of traction assistance on the procedure time of this study, contrary to the results of other CONNECT studies. Subgroup analyses, however, reflected a shorter procedure time tendency in patients with a lesion diameter of ≥30 mm in traction ESD (69 vs. 89 min, P = 0.05) and nonexpert operators (64 vs. 81 min, P = 0.07). Notably, nine conventional cases (7%) were converted to the traction method during the procedure, which could have underestimated the result in the intention-to-treat analysis. It is surmised that the use of traction devices would be more effective for challenging larger lesions and nonexperts. These controversial results among RCTs raise an important question of whether an RCT is the best study design to measure the effectiveness of traction devices in the current inaugural phase when novel devices still appear continuously. While performing ESD, endoscopists face complex multiple procedural tasks, such as identifying and defining the optimal tissue plane, precisely dissecting target tissues to minimize bystander tissue damage, promptly managing bleeding, and gently retrieving an excised specimen. Moreover, the procedural challenges of ESD are greatly affected by unstable surrounding conditions, such as anatomical location, tissue vascularity, respiratory changes, submucosal fibrosis, and even peristalsis, which changes case-by-case and sometimes moment-by-moment. In the CONNECT-E study, the simple hollow anatomy of the esophagus might enable traction-assisted ESD to be more easily accepted by operators, regardless of their skill and experience. Meanwhile, the broad range of variable conditions observed in the stomach and colorectum with larger and more intricate spaces may explain the reasons for the negative outcomes of CONNECT-G and CONNECT-C. We anticipate that traction devices could be occasionally useful during ESD, even in the stomach and colorectum, but such effectiveness would be difficult to find in RCTs assigning cases to ESD, with or without the use of a traction device throughout the procedure. The results of this study imply that the tested traction techniques could be more effective for nonexperts, but troublesome for experts who can accommodate various challenges using conventional tool sets. Lastly, traction devices cannot be easily readjusted once they are fixed to tissues. Therefore, the negative results of this RCT clarified that the application of these devices at the beginning of the procedure would not resolve every challenge encountered during ESD. The development of traction devices is still incomplete. We believe that continuous refinements of these devices would provide a more intuitive additional hand for endoscopists, and the next RCT would find a different conclusion. Authors declare no conflict of interest for this article. None.

The Jikei University School of Medicine, Japan.

Esophageal adenocarcinoma derived from the ectopic gastric mucosa of the cervical esophagus is very rare. Little is known about the efficacy of endoscopic treatment of these superficial lesions. Herein, we report the first case of lymph node metastasis after endoscopic submucosal dissection of a lesion with invasion into the muscularis mucosa. A 46-year-old man underwent esophagogastroduodenoscopy during a health checkup. Endoscopy revealed a 10-mm-sized nodular and a 5-mm-sized depressed lesion within the ectopic gastric mucosa of the cervical esophagus. The biopsy specimen confirmed the presence of adenocarcinoma. The entire ectopic gastric mucosa was resected by endoscopic submucosal dissection, and pathological examination showed invasion of the muscularis mucosa. A follow-up computed tomography scan revealed lymph node metastasis 12 months post-treatment. The patient underwent surgical mediastinal lymphadenectomy. The patient has been regularly followed up with a computed tomography scan and endoscopy for 2 years post-surgery with no evidence of recurrence. Close follow-up or additional treatment after endoscopic submucosal dissection should be considered and discussed with the patient if invasion into the muscularis mucosa is observed on pathological examination.