Safety and Efficacy of Cold Snare Polypectomy Without Submucosal Injection for Large Sessile Serrated Lesions: A Prospective Study.

BACKGROUND & AIMS: Cold snare polypectomy (CSP) has become the standard resection method for small colorectal polyps (<10 mm). Sessile serrated lesions (SSL) have low prevalence of advanced histology irrespective of size, and thus could be amenable to CSP. In this study, we evaluated the safety and efficacy of CSP for SSLs ≥10 mm. METHODS: Between November 2018 and January 2020, we prospectively enrolled 300 consecutive patients who underwent CSP for 474 SSLs ≥10 mm. To delineate SSL borders, indigo carmine chromoendoscopy and/or image-enhanced endoscopy was conducted. Piecemeal CSP (pCSP) was performed in cases where en-bloc resection was difficult. Biopsy specimens were obtained from the margins of the post-polypectomy defect to confirm complete resection. Surveillance colonoscopy was performed to screen for local recurrence. RESULTS: All lesions were successfully resected using CSP without submucosal injection. The median diameter of the resected lesions was 14 mm, and pCSP was used to resect 106 (22%) lesions. Post-polypectomy biopsies revealed residual serrated tissue in only one case (0.2%). Adverse events included immediate bleeding in 8 (3%) patients; no delayed bleeding events occurred, irrespective of the use of antithrombotic drugs. During a 7-month median follow-up period, surveillance colonoscopies were performed for 384 lesions (81%), and no local recurrences were detected. CONCLUSIONS: CSP without submucosal injection is a safe and effective treatment for SSLs ≥10 mm. UMIN Clinical Trials, Number: UMIN000034763.

Evaluation of colorectal endoscopic submucosal dissection using a multifunctional snare: a prospective clinical feasibility study (with videos).

BACKGROUND AND AIMS: The number of colorectal endoscopic submucosal dissections (ESDs) for early colorectal cancer is expected to increase in the future; therefore, cost reduction is a clinically important issue. The SOUTEN snare (Kaneka Medics, Tokyo, Japan) is a novel multifunctional snare developed for hybrid ESD at a low price. If ESD can be performed safely using the SOUTEN snare, the same therapeutic effect can be obtained as with conventional ESD at a lower cost. The aim of this prospective, pilot, clinical feasibility study was to evaluate the safety and efficacy of ESD using the SOUTEN snare (SOUTEN-ESD). METHODS: From October 2018 to January 2019, 119 consecutive patients (121 ESD procedures, 137 colorectal neoplasms) were prospectively enrolled and treated by SOUTEN-ESD at NTT Medical Center Tokyo and Omori Red Cross Hospital. The outcomes of SOUTEN-ESD were evaluated. RESULTS: Among 137 neoplasms, SOUTEN-ESD was completed in all cases. No cases required conversion to hybrid ESD or to a dedicated ESD device. The mean procedure time was 26.1 ± 14.3 minutes. Both the en-bloc resection rate and R0 resection rate were 100%. The rate of perforation was 0%, the rate of delayed bleeding was 2.2%, and the rate of post-ESD coagulation syndrome was 2.9%. CONCLUSIONS: SOUTEN-ESD was safe and had good outcomes. Although further studies are required to examine indications for SOUTEN-ESD and confirm the results of this study, effective ESD with this novel knife is feasible. The SOUTEN snare is a realistic option for colorectal ESD. (Clinical trial registration number: UMIN 000034299.).

Endoscopic submucosal dissection of large pedunculated polyps with wide stalks: a retrospective multicenter study.

BACKGROUND: Endoscopic resection of large pedunculated colorectal polyps is technically difficult, especially when the polyp is large and has such a thick stalk that it is either too difficult or impossible to resect prophylactically by a conventional snare. Here, we evaluated the feasibility of ESD for large pedunculated polyps with wide stalks. METHODS: 29 patients with large pedunculated polyps that were not resectable by polypectomy or endoscopic mucosal resection were enrolled in the study. RESULTS: En bloc resection was achieved in 28/29 polyps. One suspended case was due to severe fibrosis with muscle retraction signs. The mean diameter of the 29 polyp heads was 39.7 (standard deviation 6.9) mm. Submucosal fibrosis was present in 16 polyps (9 mild; 7 severe). The stalks of severely fibrotic polyps were significantly thicker than those of polyps with no or mild fibrosis. The curative resection rate was 85.7 % without severe complications. CONCLUSIONS: ESD is feasible for the removal of large pedunculated polyps with wide stalks when conventional snare resection is difficult or impossible.

A new classification for the diagnosis of superficial non-ampullary duodenal epithelial tumors using endocytoscopy: A prospective study.

BACKGROUND AND AIM: Although the frequency of endoscopic diagnosis of superficial non-ampullary duodenal epithelial tumors (SNADETs) has been increasing in recent years, no criteria for the endoscopic diagnosis of these tumors have been established yet. The aim of this study was to assess the usefulness of endocytoscopy for diagnosis SNADETs and to establish new criteria. METHODS: This prospective study was conducted at the NTT Medical Center Tokyo from May 2019 to July 2020, and a total of 100 consecutive SNADETs were enrolled. All the endocytoscopic images of the lesions and surrounding normal mucosa were classified into three groups according to the degree of structural atypia and the nuclear morphology and size. The endocytoscopic diagnoses using endocytoscopic classification was compared with the final histopathological diagnoses. RESULTS: Data of 93 patients with 98 lesions were included in the analysis. The preoperative diagnosis by endocytoscopy coincided with the final histopathological diagnosis in 85 (86.7%) of 98 SNADETs. In addition, the sensitivity and specificity for VCL 4/5 were 87.7% and 85.4%, respectively. In contrast, the accuracy, sensitivity, and specificity of preoperative diagnosis by biopsy were 64.3%, 50.9%, and 82.9%, respectively. Preoperative diagnosis by endocytoscopy showed significantly superior accuracy and sensitivity as compared with preoperative biopsy diagnosis (P < 0.001, respectively). CONCLUSIONS: This new classification (endocytoscopic classification) allows prediction of the tumor histopathology in real time, during endocytoscopy without biopsy, and is expected to be of help in determining the appropriate therapeutic strategies for individual cases of SNADETs. (Clinical trial registration number: UMIN000038643.).

Endoscopic submucosal dissection for colorectal neoplasms in proximity or extending to a diverticulum.

BACKGROUND AND AIMS: At specialized facilities, endoscopic submucosal dissection (ESD) has currently been performed even for difficult cases such as tumors extending to a diverticulum that previously required surgery. This study aims to classify the type of lesion according to the degree of infiltration to a diverticulum and assessed the safety and efficacy of ESD for each type of lesion. METHODS: We retrospectively reviewed ESD for lesions at NTT Medical Center Tokyo between January 2014 and April 2019. Lesions were classified as follows: Type 1: lesions in contact with or within 3 mm of the edge of a diverticulum; Type 2: lesions that partially infiltrated into a diverticulum; and Type 3: lesions that infiltrated into and completely covered the diverticulum. Furthermore, ESD strategies were divided into A and B, which indicates that a lesion was resected separately from the diverticulum and along the entire diverticulum, respectively. The clinicopathological characteristics and clinical outcomes were analyzed according to the strategy. RESULTS: A total of 47 lesions satisfied inclusion criteria (19 Type 1, 12 Type 2, and 16 Type 3 lesions). 19 Type 1 and 8 Type 2 lesions were resected using Strategy A, while 4 Type 2 and 16 Type 3 lesions were resected using Strategy B. En bloc resection was achieved in all cases. In Strategy A, the R0 resection rate was 96.3% and the curative resection rate was 88.9%. On the contrary, in Strategy B, the R0 resection rate was 95.0% and the curative resection rate was 90.0%. In Strategy B, one of the patients developed post-operative bleeding that required endoscopic hemostasis; another patient developed delayed perforation that required emergency surgery. CONCLUSIONS: ESD for colorectal neoplasms in proximity or extending to a diverticulum is challenging, but this procedure can be a safe and effective therapeutic option.

Simple scoring system for the diagnosis of superficial non-ampullary duodenal epithelial tumors.

BACKGROUND AND AIMS: Differentiating superficial non-ampullary duodenal epithelial tumors (SNADETs) that harbor malignant potential is important. We developed a simple scoring system and investigated whether it enables the differentiation of low-grade adenoma and high-grade adenoma/adenocarcinoma. PATIENTS AND METHODS: We retrospectively enrolled 197 consecutive patients with 207 SNADETs who underwent endoscopic resection at NTT Medical Center Tokyo between March 2016 and May 2019. Endoscopic findings were compared between Vienna Classification (VCL) C3 and C4/5 lesions. A multivariate logistic regression analysis was performed to develop a scoring system to identify VCL C4/5 lesions. The efficacy of our scoring system was elucidated among five novice and five expert endoscopists. RESULTS: Of 207 SNADETs, 66 and 141 lesions were pathologically diagnosed as VCL C3 and C4/5. A multivariate logistic regression analysis identified a tumor diameter of 10-19 mm (OR, 3.81; 95% CI, 1.02-14.2; P = 0.04), a tumor diameter ≥20 mm (OR, 95.2; 95% CI, 10.4-871.0; P < 0.001), a red color (OR, 14.5; 95% CI, 3.55-59.6; P < 0.001), the presence of irregular surface pattern (OR, 12.4; 95% CI, 3.00-51.4; P < 0.001), and the presence of irregular vessel pattern (OR, 13.7; 95% CI, 4.03-46.6; P < 0.001) as independent significant predictors of VCL C4/5. Considering these results, we developed a scoring system. Using an appropriate cutoff value, the diagnostic accuracy, sensitivity and specificity were calculated as 92%, 95% and 93%. The average diagnostic accuracy did not differ between novice and expert endoscopists (86% vs 87%, P = 0.76). CONCLUSIONS: Our scoring system was useful for differentiating VCL C3 and C4/5 lesions. UMIN Clinical Trials (No. 000039063).

Risk factors of delayed bleeding after endoscopic resection of superficial non-ampullary duodenal epithelial tumors and prevention by over-the-scope and conventional clipping.

OBJECTIVES: This study was aimed to reveal risk factors for delayed bleeding after endoscopic resection (ER) of superficial non-ampullary duodenal epithelial tumors (SNADETs) and at exploring measures to prevent this complication. METHODS: A total of 235 consecutive patients with 249 SNADETs who had undergone ER were enrolled in this study. They were divided into two groups: OTSC group, consisting of the initial 114 cases in which the defects were closed only using OTSCs; and OTSC-c group, consisting of the later 135 cases in which conventional clips were additionally used to cover the inverted submucosa after post-procedure defect closure using OTSCs. The therapeutic outcomes were then compared between the OTSC and OTSC-c groups. RESULTS: All lesions were successfully resected en-bloc, and the R0 resection rate was 92.4%. The complete defect closure rate was 90.0% and no delayed perforation occurred when successful defect closure was achieved. The rate of delayed bleeding was significantly higher in the OTSC group than in OTSC-c group (11.4% vs. 1.5%, P = 0.001). Multivariate logistic regression analyses revealed that tumor location distal to the ampulla (OR 10.0; 95% CI 1.24-81.0, P = 0.03) and use of a DOAC (OR 8.83; 95% CI 1.13-68.7, P = 0.04) were significant independent predictors of delayed bleeding. Propensity score-matching analysis revealed that additional use of conventional clips was associated with a significantly reduced risk of delayed bleeding (P = 0.003). CONCLUSIONS: Additional use of conventional clips after prophylactic defect closure using OTSCs appears to be useful to reduce the risk of delayed bleeding after ER of SNADETs. UMIN Clinical Trials (No. 000035478).

Efficacy of Upper Gastrointestinal Endoscopic Examination to Identify Patients with Obstructive Sleep Apnea Syndrome: A Retrospective Cross-Sectional Study.

BACKGROUND/AIMS: Despite the high prevalence of obstructive sleep apnea syndrome (OSAS), most individuals are unaware of its diagnosis. We assessed whether an upper gastrointestinal (GI) endoscopy can accurately predict the incidence of OSAS. METHODS: After endoscopic evaluation of laryngo-pharyngeal collapse, a total of 154 subjects with laryngo-pharyngeal collapse and 52 control subjects underwent polysomnography. Based on the modified Fujita Classification, upper airway obstruction was classified into 3 different types: oropharyngeal, supraglottic and combined type, and associations between upper airway obstruction and OSAS were evaluated. RESULTS: Of 154 subjects with laryngo-pharyngeal collapse, 108 (70.1%) were diagnosed as OSAS, while only 4 (7.7%) control subjects were diagnosed as OSAS (p < 0.001). The sensitivity and specificity of endoscopic diagnosis were 96.4 and 51.1%, respectively. Oropharyngeal involvement was frequently found in 90.2% of the subjects (139/154). The severity of upper airway obstruction was significantly correlated with the apnea-hypopnea index score (r = 0.55, p < 0.001). A multivariate logistic regression analysis revealed that a male sex (OR 5.20; 95% CI 2.65-10.2, p < 0.001), body mass index ≥25 kg/m2 (OR 4.98; 95% CI 2.23-11.2, p = 0.02) and severe obstruction (OR 7.79; 95% CI 3.34-18.2, p < 0.001) were significant independent predictors of severe OSAS. CONCLUSION: A conventional upper GI endoscopic examination might be useful as a diagnostic modality for OSAS.

Clinical Outcomes of Patients with Small Rectal Neuroendocrine Tumors Treated Using Endoscopic Submucosal Resection with a Ligation Device.

BACKGROUND/AIMS: The therapeutic strategies for small rectal neuroendocrine tumors (NETs) have not been standardized. We examined the efficacy and safety of endoscopic submucosal resection with a ligation device (ESMR-L) and the long-term outcomes after endoscopic treatment. METHODS: A total of 181 patients with rectal NETs <10 mm who were treated between May 2002 and May 2017 were retrospectively enrolled. All the lesions had been resected using ESMR-L, and the follow-up strategies were determined according to the pathological examinations. The long-term outcomes after a 53-month follow-up period were also evaluated. RESULTS: R0 resection was achieved in 180 cases (99.4%). Lymphovascular invasion was confirmed in 67 cases (37.0%), while a curative resection was achieved in 114 cases (63.0%). One perforation (0.6%) and 11 cases with delayed bleeding (6.1%) were observed. A multivariate logistic regression analysis revealed that a tumor size > 5 mm (OR 2.06; 95% CI 1.04-4.08, p = 0.04) was a significant independent predictor of the presence of lymphovascular invasion. Of the 67 patients with non-curative resections, 11 patients underwent additional surgery; lymph node metastasis was confirmed in 2 cases (18.2%). No local or distant metastases were observed during the follow-up period in 77 patients with a curative resection, 9 patients who received additional surgery, and 50 patients with non-curative resections. CONCLUSION: ESMR-L is an easy, safe and effective treatment for rectal NETs <10 mm in diameter, and the prognosis of patients seems to be good, despite a relatively high rate of lymphovascular invasion.

Efficacy of an over-the-scope clip for preventing adverse events after duodenal endoscopic submucosal dissection: a prospective interventional study.

BACKGROUND: Duodenal endoscopic submucosal dissection (ESD) remains technically challenging, with a high risk of severe adverse events. Because exposure of the duodenal post-ESD mucosal defect to pancreatic juice and bile acid reportedly induces delayed perforation and bleeding, we examined whether defect closure using an over-the-scope clip (OTSC) system was useful for preventing postoperative adverse events. METHODS: From April 2016 to February 2017, a total of 50 consecutive patients with superficial non-ampullary duodenal epithelial tumors (SNADETs) larger than 10 mm, with no more than semi-circumferential spread, were prospectively enrolled in this study. All of the lesions were treated by experienced ESD operators and the post-ESD mucosal defect was closed using OTSCs. RESULTS: All of the SNADETs were completely removed by ESD, with an R0 resection rate of 88.0 %. The mean procedure and closure times were 67.3 ±â€Š58.8 minutes and 9.8 ±â€Š7.2 minutes, respectively. Although complete defect closure was achieved in 94.0 % of the patients (47/50), two patients required surgical conversion. Delayed perforation occurred in only one patient (2.1 %), who did not have successful closure of the defect, as misplacement of the OTSC exposed the muscle layer. Meanwhile, delayed bleeding occurred in three patients (6.3 %); however, the bleeding was easily controlled using endoscopic coagulation. The mean duration of postoperative hospitalization was 5.5 ±â€Š7.2 days. CONCLUSIONS: Prophylactic defect closure using OTSCs may be effective in reducing severe adverse events after duodenal ESD.