Takao Maekita

Background and aim Shortening the procedure time and reducing the incidence of complications are important in patients undergoing colorectal endoscopic submucosal dissection (ESD). This prospective randomized controlled trial assessed the efficacy and safety of colorectal ESD with an internal traction-assisted device (IT-ESD) by comparing its outcomes with those of conventional ESD (without internal traction-assisted device) in patients with colorectal epithelial neoplasia. Methods A total of 201 patients who underwent ESD between March 2020 and April 2023 were prospectively randomized to IT-ESD or conventional ESD. The primary endpoint was procedure time. Secondary endpoints included rates of procedural complications, en bloc resection, curative resection, conversion, and adverse events. Results Mean procedure time was significantly shorter in patients who underwent IT-ESD than conventional ESD (95.8 ± 59.5 vs. 114.7 ± 68.3 min; p = 0.041). Although ESD trainees tended to take less time to perform IT-ESD than conventional ESD (103.2 ± 63.2 min vs 128.7 ± 76.2 min, p = 0.075), no statistically significant difference was observed. Overall complication rates associated with the procedure did not differ significantly who underwent IT-ESD and conventional ESD (13.0% vs. 17.8%; p = 0.435). Intraoperative perforations tended to be more common in conventional (7.1%) than IT-ESD (2.0%). When stratified by lesion location, procedure time was significantly shorter for IT-ESD than for conventional ESD at colon than rectum (92.9 ± 55.2 vs. 117.3 ± 69.3 min; p = 0.013). Conclusions IT-ESD significantly reduces procedure time and may enhance procedural efficiency. Furthermore, IT-ESD may contribute to improved safety and is considered particularly advantageous for colonic lesions. Trial registration The Japan Registry of Clinical Trials (JRCT; trial registration: jRCT052190089). Registered on December 25, 2019. https://jrct.niph.go.jp/latest-detail/jRCTs052190089 jRCT052190089 Version number: 4.0. Trial status: Protocol version number: 2.4.

Objectives: This pivotal study aimed to evaluate the performance of the CAD‐EYE prototype in identifying esophageal squamous cell carcinoma (ESCC) and gastric neoplasm (GN) for regulatory approval of the Pharmaceuticals and Medical Devices Agency in Japan. Methods: This retrospective study utilized image datasets comprising 15 consecutive video frames captured using non‐magnifying white‐light imaging (WLI), blue laser/light imaging (BLI), and linked color imaging (LCI). The sensitivity and specificity of the CAD‐EYE prototype for successful detection were calculated using the gold standard, which consists of image datasets of neoplastic lesions annotated by experienced endoscopists. Results: A total of 620, 679, and 682 ESCC datasets were analyzed in the WLI, BLI, and LCI groups, respectively. The sensitivity and specificity of ESCC detection were 85.9% [81.1%–90.6%] and 93.3% [90.8%–95.7%] in the WLI group, 97.6% [95.6%–99.7%] and 92.9% [90.6%–95.3%] in the BLI group, and 96.6% [94.2%–99.1%] and 93.2% [91.0%–95.5%] in the LCI group. The sensitivities for pT1a ESCC were 85.3%, 97.3%, and 97.2% in the WLI, BLI, and LCI groups, respectively. For GN, 841 WLI and 882 LCI datasets were analyzed. The sensitivity, specificity, and specificity in the detection flag of GN detection were 95.5% [92.8%–98.1%], 86.1%, and 85.4% [82.6%–88.2%] in the WLI group, and 93.9% [91.1%–96.7%], 94.4%, and 93.9% [92.0%–95.8%] in the LCI group, respectively. The sensitivities for pT1a early gastric cancer were 93.8% and 92.4% in the WLI and LCI groups, respectively. Conclusions: The CAD‐EYE prototype demonstrated high sensitivity in detecting ESCC and GN, highlighting its potential as a promising tool for clinical applications.

Background/Objectives: Esophageal varices (EVs) are a serious complication of liver cirrhosis. Guidelines for cirrhosis/chronic liver diseases (CLDs) do not specify a follow-up period or the need for esophagogastroduodenoscopy (EGD). EGD is a useful but uncomfortable procedure for the assessment of varices. Follow-up with abdominal ultrasonography (AUS) is recommended in patients with CLDs. If EVs are assessed by AUS, more patients eligible for endoscopic screening of EVs can be selected. We aimed to investigate whether AUS elastography [shear wave (Vs) and F-index] can predict the diagnosis, severity, and treatment indication of EVs. Methods: Between April 2018 and October 2022, we retrospectively collected data of 194 patients who underwent elastography and EGD for CLDs. The correlations between Vs/F-index values and presence/severity of EVs were evaluated. Each cut-off value for diagnosis and treatment indication of EVs was investigated. Results: 85 patients without exclusion criteria were enrolled. Vs and F-index values were significantly higher in patients with EVs than in patients without EVs (p = 0.0005 and 0.0021, respectively) and positively correlated with severity of EVs. The cut-off Vs and F-index values for the presence of EVs were 1.63 m/s and 1.88, respectively, with 88.1%/83.3% sensitivity, 48.8%/51.2% specificity, and 0.71/0.70 area under the curve (AUC). The cut-off Vs and F-index values for treatment indication were 1.71 m/s and 2.08, respectively, with 100%/88.2% sensitivity, 45.6%/52.9% specificity, and 0.69/0.70 AUC. There were no significant differences between the two modalities. Conclusions: Elastography may provide objective assessment and thus be a non-invasive screening tool for diagnosis and treatment indication of EVs.

Objectives: Among subepithelial lesions (SELs), gastrointestinal stromal tumors (GISTs) should be identified and surgically treated at an early stage. However, it is difficult to diagnose SELs smaller than 20 mm. In recent years, endoscopic ultrasound (EUS) elastography (EUS‐EG) and contrast‐enhanced harmonic EUS (CH‐EUS) have been reported to be useful for the diagnosis of SELs, although the diagnostic accuracy of a combination of EUS techniques with image enhancement is unknown.Methods: Patients with SELs who underwent EUS‐guided tissue acquisition, EUS shear‐wave elastography (EUS‐SWE), EUS strain elastography (EUS‐SE), and CH‐EUS from January 2019 to June 2023 were enrolled. To assess the diagnostic accuracy for differentiating GISTs from other SELs, shear‐wave velocity on EUS‐SWE, the strain ratio on EUS‐SE, and vascularity on CH‐EUS were determined and their diagnostic accuracies were compared.Results: Forty‐three patients were enrolled. When the cut‐off value was set at 3.27 m/s, the sensitivity, specificity, and diagnostic accuracy of shear‐wave velocity were 28.6%, 86.2%, and 34.9%, respectively. When the cut‐off value was set at 3.79, the sensitivity, specificity, and diagnostic accuracy of the strain ratio were 93.1%, 64.3%, and 83.7%, respectively. The sensitivity, specificity, and diagnostic accuracy of CH‐EUS were 79.3%, 92.3%, and 83.7%, respectively. When EUS‐SE was combined with CH‐EUS, the sensitivity and diagnostic accuracy were the highest among binary combinations of image enhancement modalities.Conclusions: EUS‐SE and CH‐EUS are useful for differentiating GISTs from other SELs. Furthermore, the use of both modalities may further improve the identification of GISTs.

Introduction: Endoscopic submucosal dissection (ESD) allows the en bloc resection of colorectal epithelial tumors regardless of size. Although ESD is minimally invasive and yields favorable outcomes, it is technically difficult and requires a long procedure time. In addition, colorectal ESD is associated with a particularly high risk of complications, due to the thin bowel wall, bowel flexion, and peristalsis. Direct visualization of the submucosal layer by traction of the lesion after mucosal dissection would make ESD performance easier. S-O clips traction lesions toward the lumen, facilitating direct visualization of the submucosal layer, resulting in efficient dissection due to the traction effect and adequate dissection depth. Use of this traction device can contribute to shortening the procedure time and reducing the risk of complications. This multicenter randomized controlled trial will evaluate the usefulness of the S-O clip in colorectal ESD and assess the procedure time and frequency of complications associated with the procedure. Methods/design: This multicenter, randomized control trial will enroll 200 patients at 4 hospitals in Japan undergoing ESD for colorectal epithelial tumors. Patients who meet the inclusion and exclusion criteria will be randomized to undergo ESD using S-O clips or conventional ESD. Patients will be randomized by a computer-generated random sequence with stratification by operator experience (trainee or expert), tumor location (colon/rectum), and institution. The primary endpoint will be ESD procedure time, defined as the time from the start of the local injection into the submucosal layer to the end of dissection. Other outcomes will include the rates of procedural complications, en bloc resection and cure. Discussion: ESD using the S-O clip is expected to shorten procedure time, reduce the incidence of adverse events, and standardize the procedure. This study may resolve clinical questions about whether ESD using the S-O clip traction device is more effective and safer than conventional ESD.

Esophageal varices (EVs) are often treated using endoscopic injection sclerotherapy. Endoscopic submucosal dissection (ESD) has been used for early esophageal epithelial neoplasia worldwide. We report a case of early esophageal squamous cell carcinoma (ESCC) that occurred over EVs, in which the EVs were treated with endoscopic injection sclerotherapy before the early ESCC was treated with endoscopic submucosal dissection. Argon plasma coagulation was finally performed to prevent the recurrence of varices. No serious complications, such as severe bleeding or perforation, were observed. Histopathological examination revealed submucosal veins occluded with an organized thrombus for which endoscopic injection sclerotherapy with an intravariceal injection of sclerosant had been performed, but no fibrosis was observed outside the blood vessels. This explains that the injected sclerosant into EVs did not cause any tissue reaction like fibrosis in the submucosa surrounding the vein, which may have made endoscopic submucosal dissection safer and easier. Varices have not recurred, and ESCC has also not recurred for 5 years. We demonstrated a successful treatment of ESCC on EVs and no submucosal fibrosis other than inside the occluded vessels and verified it histologically.

Introduction: Endoscopic submucosal dissection (ESD) is an advanced therapeutic technique for en bloc resection of superficial gastrointestinal neoplasms. Although gastric ESD is minimally invasive and provides favorable outcomes, it is technically difficult and requires a long procedure time for dissection. The traction-assisted approach overcomes some of the difficulties of gastric ESD, but its ability to reduce the procedure time remains unclear. The traction-assisted approach using dental floss and a clip did not reduce procedure time in the total population, but it reduced procedure time for lesions limited to the greater curvature of the upper or middle of the stomach. Although the traction direction of the clip-with-line method may be limited to the oral side via the cardia, EndoTrac ESD may provide flexible traction at any time during the procedure. This prospective randomized control study has been designed to compare the efficacy and safety of EndoTrac and conventional gastric ESD. Methods/design: This multicenter, randomized control trial will enroll 150 patients at 2 hospitals in Japan undergoing EndoTrac or conventional ESD for gastric epithelial neoplasia. Patients with a single gastric epithelial neoplasm who meet the inclusion and exclusion criteria will be randomized to EndoTrac or conventional ESD. Patients will be randomized by a computer-generated random sequence with stratification by operator experience, tumor size, tumor location, and institution. The primary endpoint will be ESD procedure time, defined as the time from the start of the submucosal injection to the completion of resection. Other outcomes will include the rates of adverse events and pathological curability Discussion: The ability of EndoTrac ESD to reduce the long procedure time and/or adverse events observed with conventional ESD can not only reduce physical stress on the patient, but can also reduce length of hospital stay and medical costs. Reduced technical difficulty will contribute to the widespread adoption of this ESD technique worldwide. Trial registration: University Hospital Medial Information Network Clinical Trials Registry (UMIN-CTR), ID: 000044450; Registered on June 6, 2021. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050485. Protocol version number: 1.1, March 1, 2022. Patient enrolment began on June 6, 2021 and is expected to be completed by July 19, 2025.

Detective flow imaging endoscopic ultrasonography (DFI-EUS) provides a new method to image and detect fine vessels and low-velocity blood flow without using ultrasound contrast agents. The aim of this study was to evaluate the utility of DFI-EUS for pancreatobiliary lesions and lymph nodes. Between January 2019 and January 2020, 53 patients who underwent DFI-EUS, e-FLOW EUS, and contrast-enhanced EUS were enrolled. The ability of DFI-EUS and e-FLOW EUS to detect vessels was compared with that of contrast-enhanced EUS. This article describes the DFI technique along with our first experience of its use for vascular assessment of pancreatobiliary lesions. Vessels were imaged in 34 pancreatic solid lesions, eight intraductal papillary mucinous neoplasms (IPMNs), seven gall bladder lesions, and four swollen lymph nodes. DFI-EUS (91%) was significantly superior to e-FLOW EUS (53%) with respect to detection of vessels (p < 0.001) and for discrimination of mural nodules from mucous clots in IPMN and gallbladder lesions from sludge (p = 0.046). Thus, DFI-EUS has the potential to become an essential tool for diagnosis and vascular assessment of various diseases.

A 68-year-old man with epigastric pain was admitted for acute pancreatitis and obstructive jaundice caused by Primary pancreatic malignant lymphoma. Computed tomography showed diffuse enlargement of the whole pancreas and dilation of the main pancreatic duct and bile duct. Endoscopic retrograde cholangiopancreatography was performed to decompress these dilated ducts. After two courses of chemotherapy, follow-up computed tomography incidentally revealed migration of the pancreatic duct stent, which had perforated the contralateral duodenal wall to enter the peritoneal cavity. In the present case, pancreatic duct stent deviation was attributed to tumor shrinkage resulting from chemotherapy. In addition, stent migration into the peritoneal cavity occurred due to repeated mechanical manipulation of the pancreatic duct stent, presumably leading to partial ulceration of the duodenal wall and delayed wound healing during chemotherapy. This case may provide valuable information on the migration of pancreatic duct stents as a rare, stent-related late complication during chemotherapy.