Endoscopic resection is widely accepted as a local treatment for rectal neuroendocrine tumors sized ≤ 10 mm. However, there is no consensus on the best method for the endoscopic resection of rectal ...neuroendocrine tumors. As a simplified endoscopic procedure, endoscopic submucosal resection with a ligation device (ESMR-L) indicates a histologically complete resection rate comparable to that of endoscopic submucosal dissection (ESD). We hypothesized that ESMR-L than ESD would be preferred for rectal neuroendocrine tumors. Hence, this trial aimed to verify whether ESMR-L is non-inferior to ESD in terms of histologically complete resection rate.
This is a prospective, open-label, multicenter, non-inferiority, randomized controlled trial of two parallel groups, conducted at the Shizuoka Cancer Center and 31 other institutions in Japan. Patients with a lesion endoscopically diagnosed as a rectal neuroendocrine tumor ≤ 10 mm are eligible for inclusion. A total of 266 patients will be recruited and randomized to undergo either ESD or ESMR-L. The primary endpoint is the rate of en bloc resection with histologically tumor-free margins (R0 resection). Secondary endpoints include en bloc resection rate, procedure time, adverse events, hospitalization days, total devices and agents cost, adverse event rate between groups with and without resection site closure, outcomes between expert and non-expert endoscopists, and factors associated with R0 resection failure. The sample size is determined based on the assumption that the R0 resection rate will be 95.2% in the ESD group and 95.3% in the ESMR-L group, with a non-inferiority margin of 8%. With a one-sided significance level of 0.05 and a power of 80%, 226 participants are required. Assuming a dropout rate of 15%, 266 patients will be included in this study.
This is the first multicenter randomized controlled trial comparing ESD and ESMR-L for the R0 resection of rectal neuroendocrine tumors ≤ 10 mm. This will provide valuable information for standardizing endoscopic resection methods for rectal neuroendocrine tumors.
Japan Registry of Clinical Trials, jRCTs042210124. Registered on Jan 6, 2022.
Objectives
Colonoscopy surveillance reduces the incidence of colorectal cancer through the detection and endoscopic removal of adenomas. Current guidelines recommend that patients with Lynch syndrome ...should have colonoscopy surveillance every 1–2 years starting at the age of 20–25. However, insufficient data are available to evaluate the quality and safety of colonoscopy surveillance for patients with Lynch syndrome nationwide in Japan.
Methods
Patients with Lynch syndrome (n = 309) from 13 institutions who underwent one or more colonoscopy procedures were enrolled in this retrospective analysis. Colonoscopy completion rate, colonoscopy‐related complication rate, proportion with an adequate colonoscopy interval, and adenoma detection rate were reviewed.
Results
The colonoscopy completion rate was 98.8% and a history of previous colorectal cancer surgery was significantly associated with a higher completion rate. All complications were associated with endoscopic treatment and the rate of bleeding needing hemostasis and perforation needing surgical repair were both 0.16% after colonoscopy with polypectomy. The adenoma detection rate at the first colonoscopy was 25%. Although there was no difference in the completion and complication rates based on differences in the colonoscopy experience of the endoscopist, the detection rate of adenomas and intramucosal cancers was significantly higher with more experienced endoscopists. The proportion of patients developing cancer was significantly higher with a >24 months than a ≤24 months interval.
Conclusion
High‐volume experienced endoscopists and appropriate surveillance intervals may minimize the risk of developing colorectal cancers in patients with Lynch syndrome.
IntroductionTotal mesorectal excision (TME) and postoperative adjuvant chemotherapy following neoadjuvant chemoradiotherapy (CRT) is the standard treatment for locally advanced rectal cancer (LARC). ...However, neoadjuvant CRT has no recognised impact on reducing distant recurrence, and patients suffer from a long-lasting impairment in quality of life (QOL) associated with TME. Total neoadjuvant therapy (TNT) is an alternative approach that could reduce distant metastases and increase the proportion of patients who could safely undergo non-operative management (NOM). This study is designed to compare two TNT regimens in the context of NOM for selecting a more optimal regimen for patients with LARC.Methods and analysisNOMINATE trial is a prospective, multicentre, randomised phase II selection design study. Patients must have clinical stage II or III (T3-T4Nany) LARC with distal location (≤5 cm from the anal verge or for those who are candidates for abdominoperineal resection or intersphincteric resection). Patients will be randomised to either arm A consisting of CRT (50.4 Gy with capecitabine) followed by consolidation chemotherapy (six cycles of CapeOx), or arm B consisting of induction chemotherapy (three cycles of CapeOx plus bevacizumab) followed by CRT and consolidation chemotherapy (three cycles of CapeOx). In the case of clinical complete response (cCR) or near cCR, patients will progress to NOM. Response assessment involves a combination of digital rectal examination, endoscopy and MRI. The primary endpoint is the proportion of patients achieving pathological CR or cCR≥2 years, defined as the absence of local regrowth within 2 years after the start of NOM among eligible patients. Secondary endpoints include the cCR rate, near cCR rate, rate of NOM, overall survival, distant metastasis-free survival, locoregional failure-free survival, time to disease-related treatment failure, TME-free survival, permanent stoma-free survival, safety of the treatment, completion rate of the treatment and QOL. Allowing for a drop-out rate of 10%, 66 patients (33 per arm) from five institutions will be accrued.Ethics and disseminationThe study protocol was approved by Wakayama Medical University Certified Review Board in December 2020. Trial results will be published in peer-reviewed international journals and on the jRCT website.Trial registration numberjRCTs051200121
Endoscopic submucosal dissection (ESD) for residual or recurrent colorectal lesions after incomplete resection is challenging because of severe fibrosis. This study aimed to compare the efficacy of ...the pocket-creation method (PCM) with a traction device (TD) with that of conventional ESD for residual or recurrent colorectal lesions.
We retrospectively studied 72 patients with residual or recurrent colorectal lesions resected using ESD. Overall, 31 and 41 lesions were resected using PCM with TD and conventional ESD methods, respectively. We compared patient background and treatment outcomes between the PCM with TD and conventional ESD groups, respectively. The primary endpoints were en bloc resection and R0 resection rates. The secondary endpoints were the dissection speed and incidence of adverse events.
En bloc resection was feasible in all cases with PCM with TD, but failed in 22% of cases of conventional ESD. The R0 resection rates for PCM with TD and conventional ESD were 97% and 66%, respectively. Dissection was significantly faster in the PCM with TD group (13.0 vs. 7.9 mm2/min). Perforation and postoperative bleeding were observed in one patient in each group.
PCM with TD is an effective method for treating residual or recurrent colorectal lesions after incomplete resection.
Various factors make complete en bloc resection by endoscopic techniques alone of some laterally spreading colorectal tumors difficult or unsafe. Drawing on recent radical developments in endoscopic ...and laparoscopic techniques for managing colorectal lesions, we aimed to develop a safe resection procedure by using a combination of laparoscopy and endoscopy. We have named this procedure laparoscopic endoscopic cooperative colorectal surgery.
We have performed this procedure on 3patients who had laterally spreading colorectal tumors. The factors contraindicating endoscopic submucosal dissection were submucosal fibrosis because of previous endoscopic mucosal resection in 1 patient and multiple surrounding diverticula in 2 patients.
The patient is placed under general anesthesia and 5 ports are inserted. Following confirmation of the tumor location by endoscopy and laparoscopy, the colon wall at this site is exposed. First, a mucosa-to-submucosa dissection circumferential to the lesion with an appropriate safety margin is performed endoscopically. Complete full-thickness dissection and excision is then performed by using ultrasonic activating scissors, endoscopy, and laparoscopy cooperatively. The excised lesion is withdrawn intraluminally with endoscopic forceps. The opened colon is then closed with laparoscopic linear staplers.
The mean operating time and blood loss in this series were 205 minutes and 13 mL. There were no intraoperative or postoperative complications. Histological examination revealed tubular adenomas with severe dysplasia and adequate surgical margins in all cases.
Laparoscopic endoscopic cooperative colorectal surgery involves removal of a minimal length of colon and is a feasible procedure for en bloc resection of some colonic lateral spreading tumors that would be difficult to resect endoscopically.
Precise endoscopic assessment of complete response to neoadjuvant chemoradiotherapy before surgery is important for optimizing surgical and non-surgical treatment. We prospectively evaluated the ...accuracy of the newly proposed endoscopic criteria to identify complete response, using magnifying chromoendoscopy.
New endoscopic criteria were created to define endoscopic complete response, near complete response and incomplete response, using magnifying chromoendoscopy. The criteria contained notable endoscopic findings, including shape of the scar, state of the ulcer, finding of white moss, presence of residual protruded nodules, regenerated pits of the scar, presence of neoplastic pit patterns, and extension of rectal wall. Seventy-nine patients with rectal cancer who received neoadjuvant chemoradiotherapy were prospectively evaluated 1–3 days before resection. Diagnostic accuracy to identify pathological complete response and interobserver agreement among a supervising colonoscopist and two trainees were investigated.
Pathological complete response was obtained in 17 patients (21.5%). The diagnostic accuracy of endoscopic complete response was 85%, with a sensitivity of 47%, specificity of 97%, positive predictive value of 80% and negative predictive value of 77%. The kappa-value for interobserver agreement across 3 doctors was 0.57 (standard error, 0.74; 95% confidence interval, 0.39–0.76).
The newly proposed endoscopic criteria using magnifying chromoendoscopy achieved excellent diagnostic accuracy to determine good responders to neoadjuvant chemoradiotherapy in rectal cancer, with fair interobserver agreement. The criteria could be clinically useful to select patients for non-surgical management.
Background and Aim
Gastric neoplasms (GN), including gastric adenoma and carcinoma, are well known as extracolonic manifestations of familial adenomatous polyposis (FAP). We aimed to investigate the ...clinicopathological features of GN in FAP patients and to clarify their relationship with the endoscopic status of the background mucosa.
Methods
We analyzed the records of 39 patients who were diagnosed with FAP and underwent esophagogastroduodenoscopy between April 2005 and July 2016. Patients were divided into two groups according to atrophic gastritis (AG) status. Endoscopic findings of GN and background mucosa, and histopathological findings, including phenotypic expression of GN and mutation locus of adenomatous polyposis coli (APC) gene, were evaluated.
Results
Gastric neoplasms were more predominant in the AG‐positive group than in the AG‐negative group (6/9, 66.7% vs 7/30, 23.3%; P = 0.039). Of 36 GN detected in 13 patients, six GN in five patients were followed and 30 GN in eight patients were endoscopically resected and analyzed. GN in the AG‐negative group frequently showed whitish color, were located in the proximal stomach, and presented the gastric immunophenotype compared to GN in the AG‐positive group. All GN were intramucosal lesions and were curatively resected regardless of AG status. APC germline mutations were identified in 32 patients. In patients with GN, a significantly higher number of mutation loci were among exons 10–15 (codons 564–1465).
Conclusion
Clinicopathological characteristics and phenotypic expressions of GN in FAP patients depend on background mucosa status with or without AG. These findings are useful for detecting GN in FAP patients.
Objectives
This study aimed to extract endoscopic findings for diagnosing colorectal neoplasia associated with sessile serrated lesions (SSLs), which are of significant interest.
Methods
To compare ...the magnifying narrow‐band imaging (NBI) findings with microscopic morphology, we classified SSLs into two groups: Group A SSLs included the majority of uniform SSLs and any dysplasia other than that classified as group B SSLs. Group B SSLs included SSLs with intramucosal and invasive carcinoma. We also quantitatively assessed visible vessels using ImageJ software.
Results
This study included 47 patients with 50 group B SSLs who underwent endoscopic resection between 2012 and 2020. The results were retrospectively compared with those of 237 patients with 311 group A SSLs that underwent endoscopic resection. Using conventional white‐light endoscopy, significantly more group B SSLs had uneven shapes and some reddening compared to group A SSLs. The diagnostic odds ratios for group B SSLs were as follows: lesions with a diameter ≥10 mm, 9.76; uneven shape, 3.79; reddening, 15.46; and visible vessels with NBI, 11.32. Regarding visible vessels with NBI, the specificity and diagnostic accuracy for group B SSLs were 94.9% and 93.1%, respectively. The percentage of the vascular tonal area of NBI images was significantly larger for group B SSLs than for group A SSLs (3.97% vs. 0.29%; p < 0.01).
Conclusions
SSLs with reddening and/or a diameter ≥10 mm are suspected to contain cancerous components. Moreover, visible vessels observed using magnifying NBI can serve as objective indicators for diagnosing SSLs with cancerous components with a high degree of accuracy.
Background: In endoscopic mucosal resection (EMR), it is essential to inject submucosal fluid to prevent complications and ensure safe and complete en bloc resection of tumors. Sodium hyaluronate ...(SH) solution, which is effective in forming and maintaining a mucosal lift and is innocuous to mucosal tissue, is considered a useful injection solution for endoscopic submucosal dissection, a procedure associated with a high risk of perforation. This study was undertaken to assess the usefulness of this solution in EMR.
Methods: Ninety‐four patients with colorectal tumors of ≤20 mm in diameter were enrolled for this study and randomized to a SH solution group (0.2% two‐fold diluted MucoUp) or to a normal saline group (control). Ease of EMR was primarily assessed based on ease of submucosal injection, ease of snaring and injection time.
Results: SH solution was superior to normal saline for ease of submucosal injection (57 ± 0.7 vs 50 ± 0.7; P < 0.05), and it showed better results for ease of snaring with less variability (63 ± 0.8 vs 51 ± 1.0; P < 0.05). The mean injection time was similar between the two groups (3.0 ± 9.0 s and 3.0 ± 2.7 s, respectively). Post‐procedural hemorrhage occurred in 7% patients (3/46) injected with SH solution and in 6% of patients (3/48) in the control group; there was no significant difference between the groups.
Conclusions: Use of two‐fold diluted MucoUp facilitated colorectal EMR.
For decades, hyperbaric oxygen therapy has been considered a treatment option in patients with chronic radiation‐induced proctitis after pelvic radiation therapy. Refractory cases of chronic ...radiation‐induced proctitis include ulceration, stenosis, and intestinal fistulas with perforation. Appropriate treatment needs to be given. In the present study, we assessed the efficacy of hyperbaric oxygen therapy in five patients with radiation‐induced rectal ulcers. Significant improvement and complete ulcer resolution were observed in all treated patients; no side‐effects were reported. Hyperbaric oxygen therapy has a low toxicity profile and appears to be highly effective in patients with radiation‐induced rectal ulcers. However, hyperbaric oxygen therapy alone failed to improve telangiectasia and easy bleeding in four of the five patients; these patients were further treated with argon plasma coagulation (APC). Although hyperbaric oxygen therapy may be effective in healing patients with ulcers, it seems inadequate in cases with easy bleeding. Altogether, these data suggest that combination therapy with hyperbaric oxygen therapy and APC may be an effective and safe treatment strategy in patients with radiation‐induced rectal ulcers.
