Efficacy and safety of same-day preparation with sodium picosulfate plus magnesium citrate on the day of colonoscopy for bowel preparation: Multicenter, single-arm, open-label study.

BACKGROUND AND AIM: Sodium picosulfate plus magnesium citrate (SP + MC) is a well-tolerated bowel preparation agent. However, Japan currently approves only two methods of taking SP + MC: the day-before and split-dose preparation, without approval of same-day preparations. This study aimed to evaluate the efficacy and safety of same-day SP + MC preparations. METHODS: This was a multicenter, single-arm, nonrandomized, open-label study. We enrolled 145 Japanese patients between June and December 2023. The patients received two sachets of SP + MC dissolved in 300 ml of water and 1200 mL or more of clear liquid on the day of colonoscopy. Bowel cleansing efficacy, adverse events (AEs), and patient satisfaction were evaluated. RESULTS: Of the enrolled patients, 137 underwent colonoscopy according to our protocol. Bowel preparation was adequate in 133 patients (97.1%). The mean total Boston Bowel Preparation Score was 8.3 ± 1.2. Five patients experienced AEs (3.6%): two (1.5%), abdominal pain; one (0.73%), ischemic enteritis; one (0.73%), vomiting or nausea; and one (0.73%), headache. All AEs were treated conservatively. None of the patients exhibited abnormal blood test results or clinical symptoms after receiving SP + MC. Regarding patient satisfaction, all patients were able to take SP + MC as directed; 136 (99.2%) expressed a preference for this bowel preparation for future colonoscopies. CONCLUSION: The same-day SP + MC preparation showed high bowel-cleansing efficacy and satisfaction in Japanese patients without serious AEs.

Characteristics of Gastric Stasis due to Deformation after Endoscopic Submucosal Dissection in the Lower Part of the Stomach.

INTRODUCTION: Gastric stasis due to deformation occurs after endoscopic submucosal dissection in the lower part of the stomach. Endoscopic balloon dilation can improve gastric stasis due to stenosis; however, endoscopic balloon dilation cannot improve gastric stasis due to deformation. Furthermore, the characteristics of gastric stasis due to deformation are unknown. This study aimed to evaluate the characteristics of gastric stasis due to deformation after endoscopic submucosal dissection in the lower part of the stomach, focusing on the differences between stenosis and deformation. METHODS: We retrospectively reviewed 41 patients with gastric stasis after endoscopic submucosal dissection in the lower part of the stomach. We evaluated the characteristics of cases with gastric stasis due to deformation, such as the risk factors of deformation and the rate of deformation in each group with risk factors. RESULTS: Deformation was observed in 12% (5/41) of the patients with gastric stasis. All cases of deformation had a circumferential extent of the mucosal defect greater than 3/4. The number of cases with pyloric dissection was significantly lower in the deformation group than in the non-deformation group (0% vs. 72%; p = 0.004). The deformation group also had a significantly higher number of cases with angular dissection than the non-deformation group (100% vs. 17%; p < 0.001). Moreover, the deformation cases had a significantly larger specimen diameter (p < 0.001). Deformation was observed only in cases with angular and non-pyloric dissections. Deformation was not observed in cases with angular and pyloric dissections. CONCLUSIONS: All cases of gastric stasis due to deformation had a circumferential extent of the mucosal defect greater than 3/4. Deformation was also likely to occur in cases with a larger dissection that exceeded the angular region without pyloric dissection.

Clinicopathological Features and the Prevalence of Oxyntic Gland Neoplasm: A Single-center Retrospective Study.

Objective We explored the clinicopathological characteristics and disease frequency of oxyntic gland neoplasms (OGNs). Methods We retrospectively evaluated the data of patients pathologically diagnosed with OGN at an internal medicine clinic. Patients A total of 13,240 upper gastrointestinal endoscopies were performed on 7,488 patients between December 1, 2017, and March 31, 2021. Results We identified 27 patients with 30 histopathologically confirmed OGNs, yielding a disease frequency of 0.36% (27/7,488). Furthermore, multiple simultaneous lesions were found in 3 of 27 patients (11%). One (3.3%) of the 30 lesions was present in the antrum, whereas the remaining lesions occurred in the body of the stomach. Nine (33%) of the 27 patients had no history of Helicobacter pylori infection, whereas the remaining 18 (67%) were either currently or had been previously infected. Nevertheless, 27/30 lesions (90%) still occurred in non-atrophied regions. After endoscopic treatment, a histopathological examination of the resected specimens revealed submucosal infiltration in 8 (44%) of the 18 lesions; however, none of the lesions showed submucosal desmoplasia. For all patients with submucosal involvement, only observation was performed. There were no recurrent lesions found on follow-up. Conclusion The period prevalence of OGN was 0.36%, which is much higher than previously reported. The discovery of a small submucosal appearing lesion with a faded yellow or white color and dilated microvasculature, especially in a non-atrophic area of the stomach, should raise suspicion for an OGN, which can be endoscopically managed.

Clinical Impact of Different Reconstruction Methods on Remnant Gastric Cancer at the Anastomotic Site after Distal Gastrectomy.

BACKGROUND/AIMS: The anastomotic site after distal gastrectomy is the area most affected by duodenogastric reflux. Different reconstruction methods may affect the lesion characteristics and treatment outcomes of remnant gastric cancers at the anastomotic site. We retrospectively investigated the clinicopathologic and endoscopic submucosal dissection outcomes of remnant gastric cancers at the anastomotic site. METHODS: We recruited 34 consecutive patients who underwent endoscopic submucosal dissection for remnant gastric cancer at the anastomotic site after distal gastrectomy. Clinicopathology and treatment outcomes were compared between the Billroth II and non-Billroth II groups. RESULTS: The tumor size in the Billroth II group was significantly larger than that in the non-Billroth II group (22 vs. 19 mm; p=0.048). More severe gastritis was detected endoscopically in the Billroth II group (2 vs. 1.33; p=0.0075). Moreover, operation time was longer (238 vs. 121 min; p=0.004) and the frequency of bleeding episodes was higher (7.5 vs. 3.1; p=0.014) in the Billroth II group. CONCLUSION: Compared to remnant gastric cancers in non-Billroth II patients, those in the Billroth II group had larger lesions with a background of severe remnant gastritis. Endoscopic submucosal dissection for remnant gastric cancers in Billroth II patients involved longer operative times and more frequent bleeding episodes than that in patients without Billroth II.

Timing of pyloric stenosis and effectiveness of endoscopic balloon dilation after pyloric endoscopic submucosal dissection.

BACKGROUND AND AIM: There have been studies on risk factors for stenosis after pyloric endoscopic submucosal dissection (ESD). However, the most appropriate strategies for the management of cases with these risk factors have not been established. This study aimed to investigate post-ESD management by evaluating the timing of stenosis and the effectiveness of endoscopic balloon dilation (EBD) after pyloric ESD. METHODS: We retrospectively reviewed cases of pyloric ESD. We first reassessed risk factors for stenosis in multivariate analysis and receiver operating characteristic curve and defined patients with the identified risk factors as the risk group. The primary outcome was the timing of stenosis in the risk group assessed by the Kaplan-Meier method. RESULTS: We reviewed 159 cases with pyloric ESD and observed pyloric stenosis in 25 cases. Cases with circumferential mucosal defect ≥ 76% were identified as the risk group. The stenosis-free probability in the risk group was 97% (95% confidence interval [CI]: 79-100%), 94% (95% CI: 76-98%), and 85% (95% CI: 66-93%) on days 7, 14, and 21, respectively. It decreased every week thereafter and did not significantly change after day 56. Twenty-three stenosis cases, except for conservative improvement, including six whole circumferential pyloric ESD cases, were improved by EBD without complications. CONCLUSIONS: Post-ESD stenosis often developed from the third to the eighth week. In all pyloric ESD cases, including whole circumferential pyloric ESD cases, pyloric stenosis was improved following EBD without complications.

Development and validation of an endoscopic submucosal dissection video assessment tool.

BACKGROUND: Despite a need for assessment of endoscopic submucosal dissection (ESD) skills in order to track progress and determine competence, there is no structured measure of assessing competency in ESD performance. The present study aims to develop and examine validity evidence for an assessment tool to evaluate the recorded performance of ESD for gastric neoplasms. METHODS: The ESD video assessment tool (EVAT) was systematically developed by ESD experienced endoscopists. The EVAT consists of a 25-item global rating scale and 3-item checklist to assess competencies required to perform ESD. Five unedited videos were each evaluated by 2-blinded experienced ESD endoscopists to assess inter-rater reliability using intraclass correlation coefficients (ICC). Seventeen unedited videos in total were rated by 3 blinded experienced ESD endoscopists. Validity evidence for relationship to other variables was examined by comparing scores of inexperienced (fellows) and experienced endoscopists (attending staff), and by evaluating the relationship between the EVAT scores and ESD case experience. Internal consistency was evaluated using Cronbach's alpha. RESULTS: The inter-rater reliability for the total score was high at 0.87 (95% confidence interval 0.11 to 0.99). The total score [median, interquartile range (IQR)] was significantly different between the inexperienced (71, 63-77) and experienced group (95, 91-97) (P = 0.005). The total scores demonstrated high correlation with the number of ESD cases (Spearman's ρ = 0.79, P < 0.01). The internal consistency was 0.97. CONCLUSIONS: This study provides preliminary validity evidence for the assessment of video-recorded ESD performances for gastric neoplasms using EVAT.

Defining competencies for endoscopic submucosal dissection (ESD) for gastric neoplasms.

BACKGROUND: Current methods for teaching and assessing competencies for endoscopic submucosal dissection (ESD) are highly variable, non-systematic, and are inefficient for the learner to acquire adequate skills. The present study aims to define and establish expert consensus regarding competencies required to perform ESD for gastric neoplasms. METHODS: Fourteen ESD experts from 12 institutions in Japan were invited to complete an online survey to rate potential items for their importance in performing ESD proficiently. By using methodology based on the Delphi principles, the results of each round were analyzed and re-sent to the experts until consensus was established. Items were included if ranked 8 out of a 10-point Likert scale, by ≥ 80% of the respondents. RESULTS: A list of 29 potential items was generated through a review of the literature, textbooks, and experience of the steering group members. Ten new items were added through the survey. Consensus was reached after three rounds. Response rate ranged from 93 to 100%. Thirty-four items achieved consensus as important surrogates of competency in performing ESD. CONCLUSIONS: Essential competencies for performing ESD were identified through expert consensus. These competencies can serve as the foundation for structured training and for development of objective assessment tools to evaluate trainee performance in ESD.

A scoping review of assessment tools for laparoscopic suturing.

BACKGROUND: A needs assessment identified a gap in teaching and assessment of laparoscopic suturing (LS) skills. The purpose of this review is to identify assessment tools that were used to assess LS skills, to evaluate validity evidence available, and to provide guidance for selecting the right assessment tool for specific assessment conditions. METHODS: Bibliographic databases were searched till April 2017. Full-text articles were included if they reported on assessment tools used in the operating room/simulation to (1) assess procedures that require LS or (2) specifically assess LS skills. RESULTS: Forty-two tools were identified, of which 26 were used for assessing LS skills specifically and 26 for procedures that require LS. Tools had the most evidence in internal structure and relationship to other variables, and least in consequences. CONCLUSION: Through identification and evaluation of assessment tools, the results of this review could be used as a guideline when implementing assessment tools into training programs.

Development of a Model for the Acquisition and Assessment of Advanced Laparoscopic Suturing Skills Using an Automated Device.

BACKGROUND: Needs assessment identified a gap regarding laparoscopic suturing skills targeted in simulation. This study collected validity evidence for an advanced laparoscopic suturing task using an Endo StitchTM device. METHODS: Experienced (ES) and novice surgeons (NS) performed continuous suturing after watching an instructional video. Scores were based on time and accuracy, and Global Operative Assessment of Laparoscopic Surgery. Data are shown as medians [25th-75th percentiles] (ES vs NS). Interrater reliability was calculated using intraclass correlation coefficients (confidence interval). RESULTS: Seventeen participants were enrolled. Experienced surgeons had significantly greater task (980 [964-999] vs 666 [391-711], P = .0035) and Global Operative Assessment of Laparoscopic Surgery scores (25 [24-25] vs 14 [12-17], P = .0029). Interrater reliability for time and accuracy were 1.0 and 0.9 (0.74-0.96), respectively. All experienced surgeons agreed that the task was relevant to practice. CONCLUSION: This study provides validity evidence for the task as a measure of laparoscopic suturing skill using an automated suturing device. It could help trainees acquire the skills they need to better prepare for clinical learning.

A novel and effective delivery method for polyglycolic acid sheets to post-endoscopic submucosal dissection ulcers.

Background and aims Shielding methods for post-endoscopic submucosal dissection (ESD) ulcers have delivery-related problems. We developed an enveloped device for this purpose and evaluated its usefulness. Materials and methods Polyglycolic acid (PGA) sheets were delivered to six 3.0-cm ulcers in two resected porcine stomachs and six 5.0-cm ulcers in another three stomachs. In the regular method group, small PGA sheets were delivered via forceps. In the novel method group, a large PGA sheet was delivered via the new device. The methods were compared in terms of time, and macroscopic and histological findings of the ulcer floor. Results The median time required to cover a 3.0-cm ulcer was 0.39 min/cm2 in the novel method group and 1.03 min/cm2 in the regular method group (P = 0.03), and to cover a 5.0-cm ulcer was 0.38 min/cm2 and 0.85 min/cm2, respectively (P = 0.03). In the novel method group, the PGA sheets were in close contact, fully covering the ulcer floor. In the regular method group, the sheets were partly elevated from the ulcer floor. Conclusions This novel technique seems promising in this preliminary study.

A large-scale multicenter study of long-term outcomes after endoscopic resection for submucosal invasive colorectal cancer.

BACKGROUND AND STUDY AIMS: Patients with submucosal invasive colorectal cancer (SM-CRC) treated with endoscopic resection who are at low risk of lymph node metastasis and local recurrence may be followed up with observation alone, while additional surgery is recommended for those with high risk features. However, the long-term outcomes that these strategies offer are still unclear. The objective of our study was to retrospectively evaluate the long-term outcomes of patients with SM-CRC managed with endoscopic resection. PATIENTS AND METHODS: We retrospectively analyzed all patients with SM-CRC treated by endoscopic resection at six institutions between 2000 and 2007. SM-CRCs with (i) negative vertical margin, (ii) well or moderately differentiated adenocarcinoma, (iii) absence of lymphovascular invasion, and (iv) invasion depth < 1000 µm were classified as low risk. Patients with SM-CRCs without these characteristics were classified as high risk. Outcomes were assessed by 5-year recurrence-free survival (RFS) and recurrence rate. RESULTS: During the study period, 428 patients with SM-CRC (low risk, 126; high risk, 302) who underwent endoscopic resection as their first treatment were enrolled (median follow-up 61 months). Among the 120 patients with low risk features treated by endoscopic resection alone, the 5-year RFS and recurrence rates were 98 % and 0.8 %, respectively. Of the 302 patients with high risk features, 196 underwent additional surgery and 106 were managed with endoscopic resection alone. For those who underwent additional surgery, the 5-year RFS and recurrence rates were 97 % and 3.6 %, respectively. Among the 106 patients managed with endoscopic resection alone, RFS and recurrence rates were 89 % (P < 0.05 vs. low risk patients treated by endoscopic resection alone) and 6.6 % (P < 0.05), respectively. CONCLUSIONS: Endoscopic resection alone is adequate for the management of patients with SM-CRC and low risk features. However, in those patients with SM-CRC and high risk features, surgery should be considered in addition to endoscopic resection.

Endoscopic evaluation of primary tumor response in patients with metastatic colorectal cancer treated by systemic chemotherapy.

BACKGROUND: The number of cases of metastatic colorectal cancer treated by chemotherapy without primary tumor resection has recently increased. However, evaluation of primary tumor response by computed tomography is difficult in such cases. In this study, the usefulness of evaluation of primary tumor response to chemotherapy by endoscopy was investigated. METHODS: This retrospective analysis was performed at the Shizuoka Cancer Center and included 31 patients (88 evaluations) with metastatic colorectal cancer. Computed tomography and endoscopy were performed concomitantly between September 2002 and June 2006. Patients were treated by systemic chemotherapy without prophylactic primary tumor resection. Definitions of primary tumor response were as follows: (1) complete response, confirmed by colorectal biopsy; (2) progressive disease, enlargement of at least one of five tumor parameters; and (3) neither (1) nor (2). Computed tomography was performed to evaluate primary tumor response according to the Response Evaluation Criteria in Solid Tumors and to identify colorectal stenosis secondary to primary tumors. RESULTS: The rate of concordance between endoscopy and computed tomography for evaluation of primary tumor response was 75%. Colorectal stenosis was detected 14 times by endoscopy (9 cases) and 3 times by computed tomography (3 cases). Of the 7 patients in whom surgery was required, 6 exhibited stenotic symptoms before endoscopic detection. CONCLUSIONS: With regard to primary tumor response evaluation, a high concordance rate was observed between endoscopy and computed tomography, although endoscopic evaluation appeared more sensitive in detecting colorectal stenosis requiring surgical treatment.

Long-term outcomes after resection for submucosal invasive colorectal cancers.

BACKGROUND & AIMS: Little is known about the long-term outcomes of patients with submucosal invasive colorectal cancer who undergo endoscopic or surgical resection. We performed a retrospective analysis of long-term outcomes of patients treated for submucosal colon and rectal cancer. METHODS: We collected data on 549 patients with submucosal colon cancer and 209 patients with submucosal rectal cancer who underwent endoscopic or surgical resection at 6 institutions over a median follow-up period of 60.5 months. Patients were classified into one of 3 groups: low-risk patients undergoing only endoscopic resection (group A), high-risk patients undergoing only endoscopic resection (group B), and high-risk patients undergoing surgical resection that included lymph node dissection (group C). We assessed recurrence rates, 5-year disease-free survival, and 5-year overall survival. Cox regression analysis was used to compare recurrences. RESULTS: The rates of recurrence, disease-free survival, and overall survival in group A for submucosal colon and rectal cancer were 0% versus 6.3% (P < .05), 96% versus 90%, and 96% versus 89%, respectively. For group B, these values were 1.4% versus 16.2% (P < .01), 96% versus 77% (P < .01), and 98% versus 96%, respectively; local recurrence was observed in 5 patients (one with submucosal colon cancer and 4 with submucosal rectal cancer). Tumor location was the only factor that contributed significantly to disease recurrence and death (hazard ratio, 6.73; P = .045). For group C, these values were 1.9% versus 4.5%, 97% versus 95%, and 99% versus 97%, respectively. CONCLUSIONS: The risk for local recurrence was significantly higher in high-risk patients with submucosal rectal cancer than in patients with submucosal colon cancer when treated with only endoscopic resection. The addition of surgery is therefore recommended for patients with submucosal rectal cancer with pathologic features indicating a high risk of tumor progression; University Hospital Medical Network Clinical Trials Registry, Number: UMIN 000008635.

Discrepancies in histologic diagnoses of early gastric cancer between biopsy and endoscopic mucosal resection specimens.

BACKGROUND: A preoperative histologic diagnosis of neoplasia is a requirement for endoscopic resection (ER). However, discrepancies may occur between histologic diagnoses based on biopsy specimens versus ER specimens. The aim of this study was to assess the rate of discrepancy between histologic diagnoses from biopsy specimens and ER specimens. METHODS: A total of 1705 gastric lesions, from 1419 patients with a biopsy diagnosis of neoplasia, were treated by ER from September 2002 to December 2008. We compared the histologic diagnosis from the biopsy sample and the final diagnosis from the ER specimen to assess the discrepancy rate. Clinicopathological characteristics of the lesions that were related to the histologic discrepancies were also studied. RESULTS: An ER diagnosis of gastric cancer was made in 49% (118/241) of lesions diagnosed as borderline lesions from biopsy specimens; this included adenomas and lesions difficult to diagnose as regenerative or neoplastic. The size, existence of a depressed area, and ulceration findings were significant factors observed in these lesions. An ER diagnosis of differentiated type cancer was obtained for 17% (12/63) of lesions diagnosed as undifferentiated type cancer from the biopsy specimens; for these lesions, the color and a mixed histology were significant factors related to the histologic discrepancies. CONCLUSION: A biopsy diagnosis of borderline lesions or undifferentiated type cancer is more likely to disagree with the diagnosis from ER specimens. Endoscopic characteristics should be considered together with the biopsy diagnosis to determine the treatment strategy for these lesions.