Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel preparation before outpatient colonoscopy: a study protocol for the multicentre, randomised, controlled E-PLUS trial.

BACKGROUND: Sodium picosulfate (SP)/magnesium citrate (MC) and polyethylene glycol (PEG) plus ascorbic acid are recommended by Western guidelines as laxative solutions for bowel preparation. Clinically, SP/MC has a slower post-dose defaecation response than PEG and is perceived as less cleansing; therefore, it is not currently used for major bowel cancer screening preparation. The standard formulation for bowel preparation is PEG; however, a large dose is required, and it has a distinctive flavour that is considered unpleasant. SP/MC requires a small dose and ensures fluid intake because it is administered in another beverage. Therefore, clinical trials have shown that SP/MC is superior to PEG in terms of acceptability. We aim to compare the novel bowel cleansing method (test group) comprising SP/MC with elobixibat hydrate and the standard bowel cleansing method comprising PEG plus ascorbic acid (standard group) for patients preparing for outpatient colonoscopy. METHODS: This phase III, multicentre, single-blind, noninferiority, randomised, controlled, trial has not yet been completed. Patients aged 40-69 years will be included as participants. Patients with a history of abdominal or pelvic surgery, constipation, inflammatory bowel disease, or severe organ dysfunction will be excluded. The target number of research participants is 540 (standard group, 270 cases; test group, 270 cases). The primary endpoint is the degree of bowel cleansing (Boston Bowel Preparation Scale [BBPS] score ≥ 6). The secondary endpoints are patient acceptability, adverse events, polyp/adenoma detection rate, number of polyps/adenomas detected, degree of bowel cleansing according to the BBPS (BBPS score ≥ 8), degree of bowel cleansing according to the Aronchik scale, and bowel cleansing time. DISCUSSION: This trial aims to develop a "patient-first" colon cleansing regimen without the risk of inadequate bowel preparation by using both elobixibat hydrate and SP/MC. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT; no. s041210067; 9 September 2021; https://jrct.niph.go.jp/ ), protocol version 1.5 (May 1, 2023).

Low-power pure-cut hot snare polypectomy for colorectal polyps 10-14 mm in size: a multicenter retrospective study.

BACKGROUND AND AIM: Hot snare excision using electrocautery is widely used for large colorectal polyps (>10 mm); however, adverse events occur due to deep thermal injury. Colorectal polyps measuring 10-14 mm rarely include invasive cancer. Therefore, less invasive therapeutic options for this size category are demanding. We have developed hot snare polypectomy with low-power pure-cut current (LPPC HSP), which is expected to contribute to less deep thermal damage and lower risk of adverse events. This study aimed to evaluate the efficacy and safety of LPPC HSP for 10-14 mm colorectal polyps, compared with conventional endoscopic mucosal resection (EMR). METHODS: In this multicenter, retrospective, observational study, clinical outcomes of EMR and LPPC HSP for 10-14 mm nonpedunculated colorectal polyps between January 2021 and March 2022 were compared using propensity score matching. RESULTS: We identified 203 EMR and 208 LPPC HSP cases. After propensity score matching, the baseline characteristics between the groups were comparable, with 120 pairs. The en bloc and R0 resection rates were not significantly different between EMR and LPPC HSP groups (95.8% vs 97.5%, P = 0.72; 90.0% vs 91.7%, P = 0.82). The rates of delayed bleeding and perforation did not differ between the groups. CONCLUSIONS: Compared with conventional EMR, LPPC HSP showed a similar resection ability without an increase in adverse events. These results suggest that LPPC HSP is a safe and effective treatment for 10-14 mm nonpedunculated colorectal polyps.

Evaluating false-positive detection in a computer-aided detection system for colonoscopy.

BACKGROUND AND AIM: Computer-aided detection (CADe) systems can efficiently detect polyps during colonoscopy. However, false-positive (FP) activation is a major limitation of CADe. We aimed to compare the rate and causes of FP using CADe before and after an update designed to reduce FP. METHODS: We analyzed CADe-assisted colonoscopy videos recorded between July 2022 and October 2022. The number and causes of FPs and excessive time spent by the endoscopist on FP (ET) were compared pre- and post-update using 1:1 propensity score matching. RESULTS: During the study period, 191 colonoscopy videos (94 and 97 in the pre- and post-update groups, respectively) were recorded. Propensity score matching resulted in 146 videos (73 in each group). The mean number of FPs and median ET per colonoscopy were significantly lower in the post-update group than those in the pre-update group (4.2 ± 3.7 vs 18.1 ± 11.1; P < 0.001 and 0 vs 16 s; P < 0.001, respectively). Mucosal tags, bubbles, and folds had the strongest association with decreased FP post-update (pre-update vs post-update: 4.3 ± 3.6 vs 0.4 ± 0.8, 0.32 ± 0.70 vs 0.04 ± 0.20, and 8.6 ± 6.7 vs 1.6 ± 1.7, respectively). There was no significant decrease in the true positive rate (post-update vs pre-update: 95.0% vs 99.2%; P = 0.09) or the adenoma detection rate (post-update vs pre-update: 52.1% vs 49.3%; P = 0.87). CONCLUSIONS: The updated CADe can reduce FP without impairing polyp detection. A reduction in FP may help relieve the burden on endoscopists.

Clinical outcomes and learning curve of Tip-in endoscopic mucosal resection for 15-25 mm colorectal neoplasms among non-experts.

BACKGROUND AND AIM: Tip-in endoscopic mucosal resection (EMR) has a high en bloc resection rate for large colorectal neoplasms. However, non-experts' performance in Tip-in EMR has not been investigated. We investigated whether Tip-in EMR can be achieved effectively and safely even by non-experts. METHODS: This retrospective study included consecutive patients who underwent Tip-in EMR for 15-25 mm colorectal nonpedunculated neoplasms at a Japanese tertiary cancer center between January 2014 and December 2020. Baseline characteristics, treatment outcomes, learning curve of non-experts, and risk factors of failing self-achieved en bloc resection were analyzed. RESULTS: A total of 597 lesions were analyzed (438 by experts and 159 by non-experts). The self-achieved en bloc resection (69.8% vs 88.6%, P < 0.001) and self-achieved R0 resection (58.3% vs 76.5%, P < 0.001) rates were significantly lower in non-experts with <10 cases of experience than in experts, but not in non-experts with >10 cases. Adverse event (P = 0.165) and local recurrence (P = 0.892) rates were not significantly different between experts and non-experts. Risk factors of failing self-achieved en bloc resection were non-polypoid morphology (OR 3.4, 95% CI 1.6-7.3, P = 0.001), lesions with an underlying semilunar fold (OR 3.6, 95% CI 1.6-7.3, P < 0.001), positive non-lifting sign (OR 3.1, 95% CI 1.2-8.0, P = 0.023), and non-experts with an experience of ≤10 cases (OR 3.6, 95% CI 2.1-6.3, P < 0.001). CONCLUSION: The clinical outcomes of Tip-in EMR for 15-25 mm lesions performed by non-experts were favorable.

A novel low-power pure-cut hot snare polypectomy for 10-14 mm colorectal adenomas: An ex vivo and a clinical prospective feasibility study (SHARP trial).

BACKGROUND AND AIM: Hot snare polypectomy using blend or coagulation current is widely used; however, it causes deeper tissue heat injury, leading to adverse events. We hypothesized that hot polypectomy using low-power pure cut current (PureCut, effect 1 10 W) could reduce deeper tissue heat injury. We conducted animal experiments to evaluate the deeper tissue heat injury and conducted a prospective clinical study to examine its cutting ability. METHODS: In a porcine rectum, hot polypectomy using Blend current (EndoCut, effect 3 40 W) and low-power pure cut current was performed. The deepest part of heat destruction and thickness of the non-burned submucosal layer were evaluated histologically. Based on the results, we performed low-power pure cut current hot polypectomy for 10-14 mm adenoma. The primary endpoint was complete resection defined as one-piece resection with negative for adenoma in quadrant biopsies from the defect margin. RESULTS: In experiments, all low-power pure-cut resections were limited within the submucosal layer whereas blend current resections coagulated the muscular layer in 13% (3/23). The remaining submucosal layer was thicker in low-power pure cut current than in blend current resections. In the clinical study, low-power pure-cut hot polypectomy removed all 100 enrolled polyps. For 98 pathologically neoplastic polyps, complete resection was achieved in 84 (85.7%, 95% confidence interval, 77-92%). The lower limit of the 95% confidence interval was not more than 15% below the pre-defined threshold of 86.6%. No severe adverse events occurred. CONCLUSIONS: A novel low-power pure-cut hot polypectomy may be feasible for adenoma measuring 10-14 mm. (UMIN000037678).

Endoscopic hand suturing using a modified through-the-scope needle holder for mucosal closure after colorectal endoscopic submucosal dissection: Prospective multicenter study (with video).

OBJECTIVES: Endoscopic hand suturing (EHS) is a novel technique for closing a mucosal defect after endoscopic submucosal dissection (ESD). We investigated the technical feasibility of colorectal EHS using a modified flexible through-the-scope needle holder. METHODS: This was a prospective multicenter study conducted at two referral centers between June 2022 and April 2023. This study included colorectal neoplasms 20-50 mm in size located in the sigmoid colon or rectum. A modified flexible through-the-scope needle holder, with an increased jaw width to facilitate needle grasping, was used for colorectal EHS. The primary end-points were sustained closure rate on second-look endoscopy (SLE) performed on postoperative days 3-4 and suturing time for colorectal EHS. Secondary end-points included complete closure rate and delayed adverse events. RESULTS: We enrolled 20 colorectal neoplasms in 20 patients, including four patients receiving antithrombotic agents. The tumor location was as follows: lower rectum (n = 8), upper rectum (n = 2), rectosigmoid colon (n = 4), and sigmoid colon (n = 6), and the median mucosal defect size was 37 mm (range, 21-65 mm). The complete closure rate was 90% (18/20 [95% confidence interval (CI) 68.3-98.8%]), and the median suturing time was 49 min (range, 23-92 min [95% CI 35-68 min]). Sustained closure rate on SLE was 85% (17/20 [95% CI 62.1-96.8%]). No delayed adverse events were observed. CONCLUSION: EHS demonstrated a high sustained closure rate. Given the long suturing time and technical difficulty, EHS should be reserved for cases with a high risk of delayed adverse events.

Proportions and characteristics of interval cancer in annual fecal immunochemical test screening and postcolonoscopy colorectal cancer: Results from a Japanese multicenter prospective study using questionnaires, the C-DETECT study.

OBJECTIVES: There are several types of colorectal cancer (CRC) according to the detection methods and intervals, including interval CRC (iCRC) and postcolonoscopy CRC (PCCRC). We aimed to examine their proportions and characteristics. METHODS: We conducted a multicenter prospective study using questionnaires in Japan ("C-DETECT study"), in which differences in CRC characteristics according to detection methods and intervals were examined from consecutive adult patients. Because the annual fecal immunochemical test (FIT) was used in population-based screening, the annual FIT-iCRC was assessed. RESULTS: In total, 1241 CRC patients (1064 with invasive CRC) were included. Annual FIT-iCRC (a), 3-year PCCRC (b), and CRC detected within 1 year after a positive FIT with noncompliance to colonoscopy (c) accounted for 4.5%, 7.0%, and 3.9% of all CRCs, respectively, and for 3.9%, 5.4%, and 4.3% of invasive CRCs, respectively. The comparison among these (a, b, c) and other CRCs (d) demonstrated differences in the proportions of ≥T2 invasion ([a] 58.9%, [b] 44.8%, [c] 87.5%, [d] 73.0%), metastasis ([a] 33.9%, [b] 21.8%, [c] 54.2%, [d] 43.9%), right-sided CRC ([a] 42.9%, [b] 40.2%, [c] 18.8%, [d] 28.6%), and female sex ([a] 53.6%, [b] 49.4%, [c] 27.1%, [d] 41.6%). In metastatic CRC, (a) and (b) showed a higher proportions of BRAF mutations ([a] [b] 12.0%, [c] [d] 3.1%). CONCLUSIONS: Annual FIT-iCRC and 3-year PCCRC existed in nonnegligible proportions. They were characterized by higher proportions of right-sided tumors, female sex, and BRAF mutations. These findings suggest that annual FIT-iCRC and 3-year PCCRC may have biological features different from those of other CRCs.

Endoscopic causes and characteristics of missed gastric cancers after endoscopic submucosal dissection.

BACKGROUND AND AIMS: Because endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) preserves the entire stomach, missed gastric cancers (MGCs) are often found in the remaining gastric mucosa. However, the endoscopic causes of MGCs remain unclear. Therefore, we aimed to elucidate the endoscopic causes and characteristics of MGCs after ESD. METHODS: From January 2009 to December 2018, all patients undergoing ESD for initially detected EGC were enrolled. According to a review of EGD images before ESD, we identified the endoscopic causes (perceptual, exposure, sampling errors, and inadequate preparation) and characteristics of MGC in each endoscopic cause. RESULTS: Of 2208 patients who underwent ESD for initial EGC, 82 patients (3.7%) had 100 MGCs. The breakdown of endoscopic causes of MGCs was as follows: 69 (69%) perceptual errors, 23 (23%) exposure errors, 7 (7%) sampling errors, and 1 (1%) inadequate preparation. Logistic regression analysis showed that the risk factors for perceptual error were male sex (odds ratio [OR], 2.45; 95% confidence interval [CI], 1.16-5.18), isochromatic coloration (OR, 3.17; 95% CI, 1.47-6.84), greater curvature (OR, 2.31; 95% CI, 1.121-4.40), and lesion size ≤12 mm (OR, 1.74; 95% CI, 1.07-2.84). The sites of exposure errors were around the incisura angularis (11 [48%]), posterior wall of the gastric body (6 [26%]), and antrum (5 [21%]). CONCLUSIONS: We identified MGCs in 4 categories and clarified their characteristics. Quality improvements in EGD observation, with attention to the risks of perceptual and site of exposure errors, can potentially prevent missing EGCs.

Clinical outcomes of endoscopic submucosal dissection for superficial circumferential esophageal squamous cell carcinoma.

BACKGROUND AND AIMS: Our aim was to elucidate the clinical outcomes of endoscopic submucosal dissection (ESD) for superficial circumferential esophageal squamous cell carcinoma (cESCC). METHODS: Consecutive patients who underwent ESD for cESCC between 2009 and 2020 were retrospectively reviewed. Short-term outcomes were en-bloc resection, R0 resection, procedure time, and adverse events, whereas long-term outcomes were overall survival (OS), disease-specific survival (DSS), cumulative recurrence rate (CRR), and clinical course. RESULTS: Fifty-two patients with 52 cESCCs (median tumor length, 5.0 cm; interquartile range [IQR], 4.0-6.3) were evaluated. The en-bloc resection and R0 resection rates were 100% (95% confidence interval [CI], 94.4-100) and 69.2% (95% CI, 54.9-81.3), respectively. The median procedure time was 112 minutes (IQR, 87-162). Intraoperative perforations and delayed bleeding occurred in 4 (7.7%) and 1 (1.9%) patients, respectively. Among the 42 patients who underwent ESD alone, 36 (85.7%) experienced esophageal strictures. Within a median follow-up of 49.1 months (IQR, 25.7-74.7), the 4-year OS, DSS, and CRR were 86.2% (95% CI, 71.6-93.6), 95.5% (95% CI, 83.1-98.9), and 11.5% (95% CI, 4.1-23.1), respectively. There was no significant difference in the OS between patients with low-risk cESCC (pT1a, negative lymphovascular invasion, and negative vertical margin) and high-risk lesions, regardless of undergoing additional treatment (P = .93). In 31 patients with low-risk cESCC who were treated with ESD alone, the 4-year OS, DSS, and CRR were 93.2%, 100%, and 0%, respectively. CONCLUSIONS: ESD is a highly curative treatment for cESCC with favorable long-term outcomes, especially in low-risk patients. Stricture-prevention techniques should be improved to optimize the benefits of ESD for cESCC.

Diagnostic performance of endoscopy for subsquamous extension of superficial adenocarcinoma of the esophagogastric junction.

OBJECTIVES: Extension of adenocarcinoma of the esophagogastric junction under the squamous epithelium may lead to errors when determining lateral margins. However, the characteristics of subsquamous extension are unclear. Herein, we evaluated the prevalence and characteristics of subsquamous extension of adenocarcinoma of the esophagogastric junction and the diagnostic performance of endoscopy for this condition. METHODS: Eighty-nine consecutive patients with superficial adenocarcinoma of the esophagogastric junction who underwent endoscopic or surgical resection at a tertiary cancer center between January 2010 and December 2017 were retrospectively evaluated. Endoscopic subsquamous extension was defined as a submucosal tumor-like elevation covered by squamous epithelium and/or a brownish area with abnormal microvessels on the squamous epithelium observed using narrow-band imaging. The diagnostic performance of endoscopy for subsquamous extension was evaluated using histological subsquamous extension as gold standard. RESULTS: Thirty-nine patients (44%) had histological subsquamous extension. Proton pump inhibitor use was significantly associated with histological subsquamous extension [odds ratio: 4.65; 95% confidence interval (CI): 1.77-12.2]. The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of endoscopic subsquamous extension were 56% (95% CI: 40-72%), 96% (86-99%), 92% (73-99%), 74% (62-84%) and 79% (69-87%), respectively. The median length difference between histological and endoscopic subsquamous extension was 2 mm (range: -6 to 9 mm). CONCLUSIONS: The sensitivity of endoscopic diagnosis of subsquamous extension was unsatisfactory. The endoscopic length of subsquamous extension tended to be underestimated. An oral safety margin of one centimeter is reasonable during endoscopic resection of adenocarcinoma of the esophagogastric junction.IMPACT STATEMENT This study will contribute significantly to the literature because this is the first study to determine the difference between the lengths of subsquamous extension detected endoscopically and histologically. This study determines the prevalence of subsquamous extension and identifies characteristics associated with subsquamous extension. An understanding of the risk of subsquamous extension is important when choosing a treatment strategy and planning the resection margins in patients with adenocarcinoma of the esophagogastric junction. This study provides patients with subsquamous extension characteristics and suggests a method for accurately diagnosing this condition.

Complete endoscopic removal rate of detected colorectal polyps in a real world out-patient practical setting.

OBJECTIVES: Colonoscopy with adenomatous polypectomy reduces the incidence and mortality of colorectal cancer. We introduced a strategy of removing all neoplastic polyps in single-session out-patient colonoscopy using cold polypectomy. We aimed to investigate the achievement of single-session complete removal rate of detected colorectal polyps in clinical practice. MATERIALS AND METHODS: This retrospective study included colonoscopy-scheduled 40-79-year-old outpatients, with at least one colorectal neoplasm, between January 2015 and December 2016. Exclusion criteria were: colorectal neoplasms 21 mm or larger in size; pre-examination for colorectal surgery or endoscopic submucosal dissection; colonoscopy performed by health check program; ongoing antithrombotic treatment; inflammatory bowel disease; familial adenomatous polyposis. We defined 'clean colon' as the removal of all detected neoplastic polyps in a single-session colonoscopy. We evaluated clean colon rate, factors relating to clean colon failure and complications. RESULTS: We evaluated 2527 patients (mean age 68 years; 799 women) with 8203 colorectal polyps (7675 adenomas, 423 serrated lesions, 105 Tis and T1 cancers). In 1-4 mm polyps, cold snare polypectomy (CSP; 51.8%) and cold forceps polypectomy (CFP; 45.8%) were applied. Clean colon rates were 95.1% per patient and 97.1% per lesion. The significant factors denoting clean colon failure were inadequate bowel preparation, ≥5 lesions, and the most advanced estimated histology of adenocarcinoma, on multivariate analyses. Post-polypectomy bleeding requiring endoscopic hemostasis occurred in five patients (0.2%) who had undergone endoscopic mucosal resection (EMR) or hot snare polypectomy (HSP). Perforation occurred in one patient (0.04%) with EMR. CONCLUSIONS: The clean colon rates were satisfactory in single-session out-patient colonoscopy using cold polypectomy.

Local recurrence risk of esophageal squamous cell carcinoma due to intralesional damage during endoscopic submucosal dissection.

BACKGROUND AND AIM: It is unclear whether additional treatment should be considered given the recurrence risk after endoscopic submucosal dissection (ESD) for esophageal squamous cell carcinoma (ESCC) when the vertical margin is positive or unclear (VM1/VMX) due to intralesional damage. This study aimed to elucidate the local recurrence risk of ESCC caused by intralesional damage during ESD. METHODS: Among consecutive patients with pT1a ESCCs initially treated by ESD at our institution between January 2006 and December 2018, ESCCs diagnosed as VM1/VMX were retrospectively reviewed. Exclusion criteria were piecemeal resection and any additional treatment after ESD. Intralesional damage included the following three types: a macroscopic hole inside the lesion, an incision from the lateral margin of the specimen into the lesion, and crushing injury or burn effect into the deepest area of the lesion without an obvious hole. The local recurrence rate after ESD was primarily analyzed. RESULTS: Of 1174 pT1a ESCCs initially treated using ESD, 22 lesions were histopathologically diagnosed as VM1/VMX due to intralesional damage (1.9%; 95% confidence interval [CI], 1.2-2.8%). At a median follow-up period of 60.0 (interquartile range, 15.0-84.0) months, no local recurrence was observed (0.0%; 95% CI, 0.0-13.3%) among 21 lesions finally evaluated. CONCLUSIONS: The impact of intralesional damage during ESD for ESCC on local recurrence might be negligible. Follow-up without additional treatment may be acceptable even if intralesional damage occurs and results in VM1/VMX after ESD for pT1a ESCCs.

Optimization of endoscopic ultrasound-guided tissue sample acquisition for commercially available comprehensive genome profiling.

BACKGROUND AND AIM: Optimal tumor samples are crucial for successful analysis using commercially available comprehensive genomic profiling (CACGP). However, samples acquired by endoscopic ultrasound-guided tissue acquisition (EUS-TA) are occasionally insufficient, and no consensus on the optimal number of needle passes required for CACGP exists. This study aimed to explore the optimal number of needle passes required for EUS-TA to procure an ideal sample fulfilling the prerequisite criteria of CACGPs. METHODS: Patients who underwent EUS-TA for solid masses between November 2019 and July 2021 were retrospectively studied. The correlation between the acquisition rate of an ideal sample and the number of needle passes mounted on a microscope slide was evaluated. Additionally, the factors predicting a successful analysis were investigated in patients scheduled for CACGP using EUS-TA-obtained samples during the same period. RESULTS: EUS-TAs using 22- and 19-gauge (G) needles were performed in 336 and 57 patients, respectively. There was a positive correlation between the acquisition rate and the number of passes using a 22-G needle (38.9%, 45.0%, 83.7%, and 100% for 1, 2, 3, and 4 passes, respectively), while no correlation was found with a 19-G needle (84.2%, 83.3%, and 85.0% for 1, 2, and 3 passes, respectively). The analysis success rate in patients with scheduled CACGP was significantly higher with ideal samples than with suboptimal samples (94.1% vs 55.0%, P < 0.01). CONCLUSIONS: The optimal estimated number of needle passes was 4 and 1-2 for 22- and 19-G needles, respectively.

Artificial Intelligence System to Determine Risk of T1 Colorectal Cancer Metastasis to Lymph Node.

BACKGROUND & AIMS: In accordance with guidelines, most patients with T1 colorectal cancers (CRC) undergo surgical resection with lymph node dissection, despite the low incidence (∼10%) of metastasis to lymph nodes. To reduce unnecessary surgical resections, we used artificial intelligence to build a model to identify T1 colorectal tumors at risk for metastasis to lymph node and validated the model in a separate set of patients. METHODS: We collected data from 3134 patients with T1 CRC treated at 6 hospitals in Japan from April 1997 through September 2017 (training cohort). We developed a machine-learning artificial neural network (ANN) using data on patients' age and sex, as well as tumor size, location, morphology, lymphatic and vascular invasion, and histologic grade. We then conducted the external validation on the ANN model using independent 939 patients at another hospital during the same period (validation cohort). We calculated areas under the receiver operator characteristics curves (AUCs) for the ability of the model and US guidelines to identify patients with lymph node metastases. RESULTS: Lymph node metastases were found in 319 (10.2%) of 3134 patients in the training cohort and 79 (8.4%) of /939 patients in the validation cohort. In the validation cohort, the ANN model identified patients with lymph node metastases with an AUC of 0.83, whereas the guidelines identified patients with lymph node metastases with an AUC of 0.73 (P < .001). When the analysis was limited to patients with initial endoscopic resection (n = 517), the ANN model identified patients with lymph node metastases with an AUC of 0.84 and the guidelines identified these patients with an AUC of 0.77 (P = .005). CONCLUSIONS: The ANN model outperformed guidelines in identifying patients with T1 CRCs who had lymph node metastases. This model might be used to determine which patients require additional surgery after endoscopic resection of T1 CRCs. UMIN Clinical Trials Registry no: UMIN000038609.

Tip-in EMR as an alternative to endoscopic submucosal dissection for 20- to 30-mm nonpedunculated colorectal neoplasms.

BACKGROUND AND AIMS: Tip-in EMR, which includes anchoring the snare tip, has recently shown a favorable en-bloc and R0 resection rate for colorectal neoplasms. Thus, Tip-in EMR may be an alternative to endoscopic submucosal dissection (ESD). We aimed to compare clinical outcomes between Tip-in EMR and ESD for large colorectal neoplasms. METHODS: This retrospective study evaluated consecutive patients who underwent Tip-in EMR or ESD for 20- to 30-mm nonpedunculated colorectal neoplasms at a Japanese tertiary cancer center between January 2014 and December 2019. Baseline characteristics, treatment results, and long-term outcomes were analyzed using 1:1 propensity score matching. RESULTS: Seven hundred nine lesions were evaluated. The Tip-in EMR group included 1 lesion with a nonlifting sign but no lesions with fold convergence. After propensity score matching, each group included 140 lesions. The ESD group showed significantly higher en-bloc resection rates (99.3% vs 85.0%) and R0 resection rates (90.7% vs 62.9%). Procedure time was significantly shorter in the Tip-in EMR group (8 minutes vs 60 minutes). The Tip-in EMR and ESD groups did not differ significantly with respect to local recurrence rate (2.1% vs 0%). CONCLUSIONS: Tip-in EMR is comparable with ESD with respect to the local recurrence rate but has a shorter procedure time, despite the lower en-bloc and R0 resection rates for 20- to 30-mm nonpedunculated colorectal neoplasms without fold convergence or nonlifting sign. Thus, Tip-in EMR could be a feasible alternative to ESD in these lesions.

Favorable Survival After Screening for Young-Onset Colorectal Cancer: Benefits of Screening in Young Adults.

BACKGROUND: The increasing incidence and mortality of young-onset colorectal cancer has drawn increasing attention. However, screening for young adults is controversial given the limited evidence regarding its effectiveness. OBJECTIVE: We aimed to clarify the characteristics of young-onset colorectal cancer and to compare long-term outcomes of screening-detected colorectal cancer and non-screening-detected colorectal cancer. DESIGN: This was a retrospective cohort study. SETTING: This study evaluated data from a colorectal cancer registry and medical records at a tertiary Japanese cancer center. PATIENTS: All patients with colorectal cancer who were registered at a Japanese tertiary cancer center between January 2007 and December 2016 were included. MAIN OUTCOME MEASURES: The colorectal cancer cases were categorized as screening-detected colorectal cancer and non-screening-detected colorectal cancer, and patients were categorized into 3 age groups: <50 years (young-onset), 50 to 75 years, and >75 years. The baseline characteristics and survival outcomes of the groups were compared using Cox regression models. RESULTS: A total of 4345 patients were identified, with a median follow-up of 4.6 years. Relative to 50- to 75-year-old individuals, young-onset colorectal cancer was linked to a higher proportion of rectal cancer (50.4% vs 43.3%), a lower proportion of screening-detected colorectal cancer (29.4% vs 35.8%), a lower proportion of stage I colorectal cancer (15.2% vs 30.3%), and a higher proportion of stage III to IV colorectal cancer (64.0% vs 49.4%). Among patients who were <50 years old, screening-detected colorectal cancer was associated with a 50% lower risk of mortality relative to non-screening-detected colorectal cancer (HR, 0.50; 95% CI, 0.26-0.95). LIMITATIONS: The findings were limited by the retrospective analysis from a single center. CONCLUSIONS: Young-onset colorectal cancer was more likely to present at an advanced stage and had a lower rate of screening-detected colorectal cancer. Nevertheless, young-onset screening-detected colorectal cancer was associated with better overall survival than non-screening-detected colorectal cancer. See Video Abstract at http://links.lww.com/DCR/B829 . SUPERVIVENCIA FAVORABLE DESPUS DEL CRIBADO DEL CNCER COLORRECTAL EN PACIENTE JOVEN BENEFICIOS DEL CRIBADO EN ADULTOS JVENES: ANTECEDENTES:La creciente incidencia y mortalidad del cáncer colorrectal en paciente joven ha atraído una atención cada vez mayor. Sin embargo, el cribado para adultos jóvenes es controvertido, dado la evidencia limitada con respecto a su efectividad.OBJETIVO:Nuestro objetivo fue identificar las características del cáncer colorrectal en paciente joven y comparar los resultados a largo plazo del cáncer colorrectal detectado por cribado y el cáncer colorrectal no detectado por cribado.DISEÑO:Este fue un estudio de cohorte retrospectivo.ESCENARIO:Este estudio evaluó datos de un registro de cáncer colorrectal y registros médicos en un centro oncológico terciario japonés.PACIENTES:Se incluyeron todos los pacientes con cáncer colorrectal registrados en un centro oncológico terciario japonés entre enero de 2007 y diciembre de 2016.PRINCIPALES MEDIDAS DE RESULTADO:Los casos de cáncer colorrectal se categorizaron como cáncer colorrectal detectado mediante cribado y cáncer colorrectal no detectado mediante cribado, y los pacientes se clasificaron en tres grupos de edad: <50 años (joven), 50-75 años y >75 años. Las características basales y los resultados de supervivencia de los grupos se compararon mediante modelos de regresión de Cox.RESULTADOS:Se identificaron un total de 4345 pacientes, con una mediana de seguimiento de 4,6 años. En relación con las personas de 50 a 75 años, el cáncer colorrectal de inicio en la juventud se relacionó con una mayor proporción de cáncer de recto (50,4% frente a 43,3%), una menor proporción de cáncer colorrectal detectado mediante exámenes de cribado (29,4% frente a 35,8%), una menor proporción de cáncer colorrectal en estadio I (15,2% frente a 30,3%) y una mayor proporción de cáncer colorrectal en estadio III-IV (64,0% frente a 49,4%). Entre los pacientes menores de 50 años, el cáncer colorrectal detectado mediante cribado se asoció con un 50% menos de riesgo de mortalidad, en comparación con el cáncer colorrectal no detectado mediante cribado (HR: 0,50; IC 95%: 0,26-0,95).LIMITACIONES:Los hallazgos fueron limitados por el análisis retrospectivo de un solo centro.CONCLUSIONES:El cáncer colorrectal en paciente joven presenta más probabilidades de presentarse en una etapa avanzada y con una tasa más baja de detección mediante cribado. No obstante, el cáncer colorrectal detectado por cribado de aparición temprana se asoció con una mejor supervivencia general que el cáncer colorrectal no detectado por cribado. Consulte Video Resumen en http://links.lww.com/DCR/B829 . (Traducción-Dr. Felipe Bellolio ).

Biliary obstruction and pancreatitis after duodenal stent placement in the descending duodenum: a retrospective study.

BACKGROUND: Metallic stents placed in the descending duodenum can cause compression of the major duodenal papilla, resulting in biliary obstruction and pancreatitis. These are notable early adverse events of duodenal stent placement; however, they have been rarely examined. This study aimed to assess the incidence of and risk factors for biliary obstruction and/or pancreatitis after duodenal stent placement in the descending duodenum. METHODS: We retrospectively reviewed data of consecutive patients who underwent metallic stent placement in the descending duodenum for malignant gastric outlet obstruction at a tertiary referral cancer center between April 2014 and December 2019. Risk factors for biliary obstruction and/or pancreatitis were analyzed using a logistic regression model. RESULTS: Sixty-five patients were included. Biliary obstruction and/or pancreatitis occurred in 12 patients (18%): 8 with biliary obstruction, 2 with pancreatitis, and 2 with both biliary obstruction and pancreatitis. Multivariate analysis indicated that female sex (odds ratio: 9.2, 95% confidence interval: 1.4-58.6, P = 0.02), absence of biliary stents (odds ratio: 12.9, 95% confidence interval: 1.8-90.2, P = 0.01), and tumor invasion to the major duodenal papilla (odds ratio: 25.8, 95% confidence interval: 2.0-340.0, P = 0.01) were significant independent risk factors for biliary obstruction and/or pancreatitis. CONCLUSIONS: The incidence of biliary obstruction and/or pancreatitis after duodenal stent placement in the descending duodenum was non-negligible. Female sex, absence of biliary stents, and tumor invasion to the major duodenal papilla were the primary risk factors. Risk stratification can allow endoscopists to better identify patients at significant risk and permit detailed informed consent.

Feasibility of endoscopic submucosal dissection for cecal tumors involving the ileocecal valve or appendiceal orifice.

BACKGROUND AND AIM: Endoscopic resection of the ileocecal valve lesions (ICVL) and peri-appendiceal orifice lesions (PAOL), is challenging. This study aimed to evaluate the feasibility of endoscopic submucosal dissection (ESD) for ICVLs and PAOLs compared with other cecal lesions (OCEL). METHODS: This was a multicenter, retrospective cohort study conducted at a cancer center hospital and two community hospitals. Non-pedunculated cecal lesions that were intended to be treated by ESD followed by at least one surveillance colonoscopy were included. The main outcome was curative resection defined as en-bloc resection and R0 resection without risk factors of metastases. The secondary outcome was co lon preservation. RESULTS: A total of 206 patients with 206 cecal lesions, including 37 ICVL, 27 PAOL, and 142 OCEL, who were to be treated with ESD were included in this study. Curative resection rates were 75.7% for ICVL, 70.4% for PAOL, and 77.5% for OCEL (P = 0.67). In the multivariate analysis of predictors of curative resection, tumor size (<40 mm) (odds ratio [OR] 2.40; 95% confidence intervals [CI], 1.14-5.04; P = 0.02) and a negative non-lifting sign (OR 6.12; 95% CI, 2.55-14.60; P < 0.01) were significant. Colon preservation was achieved for 91.9% of the ICVL, 92.6% of the PAOL, and 90.8% of the OCEL (P = 0.947). CONCLUSIONS: Based on curative resection and colon preservation rates, ESD was found to be feasible for ICVL and PAOL. Large tumor size (≥ 40 mm) and positive non-lifting signs were significant factors for non-curative resection.

Predicting the depth of superficial adenocarcinoma of the esophagogastric junction.

BACKGROUND AND AIM: Preoperative determination of the invasion depth of superficial adenocarcinoma of the esophagogastric junction is important for appropriate endoscopic or surgical resection. There are no objective criteria regarding this; therefore, we investigated the factors associated with the invasion depth of superficial adenocarcinoma of the esophagogastric junction. METHODS: This retrospective study evaluated patients with superficial adenocarcinoma of the esophagogastric junction who had undergone endoscopic or surgical resection at a Japanese tertiary cancer center between April 2004 and December 2017. We analyzed endoscopic features of intramucosal to slight submucosal (M-SM1; < 500 µm) and deep submucosal (SM2; ≥ 500 µm) adenocarcinoma of the esophagogastric junction and extracted significant factors associated with and assessed the diagnostic performance of endoscopic features for SM2 lesion. RESULTS: A total of 106 cases were included in this study. Multivariate analysis indicated that depressed or protruded type (odds ratio [OR], 11.1), lesion size ≥ 15 mm (OR, 3.11), uneven surface (OR, 6.31), and subsquamous extension (OR, 5.41) were significantly associated with SM2 adenocarcinomas of the esophagogastric junction. When the macroscopic type was depressed or protruded, high sensitivity (97%) but fair specificity (46%) were observed for SM2 adenocarcinoma of the esophagogastric junction, whereas uneven surface and subsquamous extension showed high specificity (96% and 87%) but fair sensitivity (36% and 46%). CONCLUSIONS: Depressed or protruded type, lesion size ≥ 15 mm, uneven surface, and subsquamous extension were significantly associated with the invasion depth of superficial adenocarcinoma of the esophagogastric junction. These endoscopic features are useful in determining the treatment method preoperatively.

Cold snare polypectomy for superficial non-ampullary duodenal epithelial tumor: a prospective clinical trial (pilot study).

BACKGOUND: Cold snare polypectomy (CSP) can minimize the risk of adverse events and has become a standard treatment for small colorectal polyps. CSP might also be suitable for small superficial non-ampullary duodenal epithelial tumors (SNADETs). This study aimed to evaluate the safety of CSP for SNADETs. METHODS: The major indication criteria were as follows: (1) endoscopically diagnosed SNADET, (2) ≤ 10 mm, and (3) a single primary lesion. CSP was performed using an electrosurgical snare without electrocautery. Follow-up endoscopy and scar biopsy were performed 3 months after CSP. The primary endpoint was the delayed adverse events rate. RESULTS: In total, 21 patients were enrolled. Two and 19 lesions were located in the duodenal bulb and 2nd portion, respectively; the median lesion size was 8 mm. CSP was attempted for all lesions; three lesions could not be resected without electrocautery and were removed by conventional endoscopic mucosal resection (EMR). The rate of spurting bleeding after CSP was 0%. The median procedure time was 12 min, the median resected specimen size was 12 mm, and the rate of en bloc resection was 81% (17/21). No adverse events were observed intraoperatively, with no delayed adverse events after CSP. Histopathology revealed 15 adenomas, 4 cancers (intramucosal), and 2 non-neoplastic lesions. The horizontal margins were negative/positive/undetermined in 9, 1, and 11 cases, respectively. All vertical margins were negative. Only one recurrence was detected by follow-up endoscopy 3 months after CSP. CONCLUSIONS: CSP can be performed safely for small SNADETs. CLINICAL TRIAL REGISTRATION: This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry ( http://www.umin.ac.jp/ctr/index.htm ), and the registration number is UMIN000019157.