Multicenter prospective randomized controlled clinical trial comparing the pocket-creation method with and without single-clip traction of colonic endoscopic submucosal dissection.

BACKGROUND: The pocket-creation method (PCM) was developed to overcome the technical difficulties of endoscopic submucosal dissection (ESD), although opening the pocket remains challenging. We developed a novel technique of PCM with single-clip traction (PCM-CT), which uses a reopenable clip as a traction device to maintain stability during the procedure. No prospective study has compared the efficacy of PCM-CT and PCM. This study aimed to investigate the effectiveness of PCM-CT vs. PCM in a randomized controlled trial. METHODS: This randomized controlled clinical trial was conducted at four Japanese institutions. Patients with superficial colorectal neoplastic lesions were included following Japanese guidelines for colorectal cancer. Seven moderately experienced endoscopists performed the ESD procedures using either PCM-CT or PCM. RESULTS: 100 patients were enrolled in the study. Compared with PCM, PCM-CT achieved significantly faster mean (SD) dissection speed (21.4 [10.8] vs. 27.0 [14.5] mm2/min [95%CI 0.5 to 10.7], P = 0.03), and reduced the mean procedure time (81.8 [57.9] vs. 64.8 [47.6] minutes [95%CI -38.2 to 4.3], P = 0.12) and pocket-opening time (37.8 [33.0] vs. 30.0 [28.9] minutes [95%CI -20.2 to 4.6], P = 0.22). En bloc and R0 resection rates were not significantly different between the two groups (100% vs. 100%, P >0.99; 100% vs. 96%, P = 0.50, respectively). No significant differences were observed in adverse events between the two groups. CONCLUSION: ESD facilitated by the novel PCM-CT method appeared to be significantly faster than PCM. Both methods achieved high R0 resection rates.

Maintenance of complete mucosal healing is associated with avoiding restenosis after endoscopic balloon dilation of Crohn's disease-related small intestinal strictures.

Background: Endoscopic balloon dilation (EBD) is an effective, minimally invasive treatment for Crohn's disease (CD) related intestinal strictures. However, restenosis frequently occurs and requires repetitive EBD or surgical resection. Since previous studies could not evaluate restenosis based on stricture diameter, factors affecting restenosis after EBD were unclear. This study aimed to identify these factors by precisely measuring the diameter of small intestinal strictures in patients with CD. Methods: This single-center retrospective study enrolled patients with CD with de novo small intestinal strictures who underwent two double-balloon enteroscopy sessions (EBD and follow-up) between January 2016 and October 2021. Clinical and endoscopic data were obtained from electronic medical records. A calibrated small-caliber-tip transparent hood was used to precisely measure stricture diameters. Multivariate analysis was performed to identify factors associated with restenosis. Results: Forty-eight patients (37 male) were analyzed. The total number of strictures detected decreased from 162 to 143. The mean diameter of all strictures and the narrowest stricture in each patient increased significantly from 8.6 to 9.8 mm and from 7.6 to 8.7 mm, respectively. Thirty-two (67%) patients developed endoscopic restenosis. Multivariate analysis showed that the presence of ulcers at the follow-up session was a risk factor for restenosis (odds ratio 9.4, p = 0.01). Patients with complete mucosal healing at both sessions (n = 21) showed significant improvement in the narrowest stricture (+1.7 mm, p = 0.001). Conclusions: Maintenance of complete mucosal healing is significantly associated with avoiding restenosis after EBD in CD-related small intestinal strictures.

Endoscopic treatment of intussusception due to small intestine polyps in patients with Peutz-Jeghers Syndrome.

Background and study aims Intussusception caused by intestinal polyps in patients with Peutz-Jeghers syndrome usually requires laparotomy. Patients following successful endoscopic reduction using double-balloon endoscopy (DBE) have been reported. The aim of this study was to evaluate the feasibility of endoscopic treatment of intussusception. Patients and methods We retrospectively reviewed patients who underwent DBE for intussusception due to small intestine polyps in patients with Peutz-Jeghers syndrome from January 2004 to June 2020. Results Twenty-seven (antegrade 22, retrograde 5) DBEs were performed in 19 patients with 25 sites of intussusception identified during the study period. If the intussusception remained once the endoscope reached the site, endoscopic reduction of the intussusception was performed as needed (15 sites). Ultimately, endoscopic resections (8 sites) or ischemic polypectomies (16 sites) of the polyp causing the intussusception were completed at 24 sites. Only one site could not be treated endoscopically and was treated surgically. The final per-site and per-patient success rates of endoscopic treatment were 96 % (24/25) and 95 % (18/19) respectively. Two patients developed mild acute pancreatitis and one patient developed intussusception after the procedures, both of which were treated non-operatively. Conclusions Endoscopic treatment of intussusception is feasible to avoid laparotomy in patients with Peutz-Jeghers syndrome.

Feasibility of progressive polyp contraction with underwater endoscopic mucosal resection in ≥ 20 mm superficial colorectal lesions.

Background and study aims Underwater endoscopic mucosal resection (UEMR) does not always result in en bloc resection of large colorectal lesions. The aim of this study was to demonstrate the feasibility of en bloc resection with progressive polyp contraction with underwater endoscopic mucosal resection (PP-CUE) of large, superficial colorectal lesions. The advantage of PP-CUE is to enable resection of a superficial non-polypoid lesion that is larger than the snare diameter. Patients and methods Eleven consecutive lesions in ten patients who underwent UEMR with PP-CUE of large superficial colorectal lesions (20 mm or greater) were included. Results The median lesion diameter was 24 mm (interquartile range [IQR], 20-24 mm). All lesions were larger than the 15-mm rotatable snare that was used. Median procedure time and PP-CUE time were 11 minutes (IQR, 8.5-12.3) and 2.3 minutes (IQR, 1.9-3.4), respectively. Pathological diagnoses of resected specimens included six adenomas, three sessile serrated lesions, and two slightly invasive submucosal carcinomas. En bloc and R0 resection rates were both 91 % (10/11). No adverse events occurred. Conclusions PP-CUE is useful to resect superficial non-polypoid colorectal lesions 20 to 25 mm in diameter in an en bloc fashion.

Images of laser and light-emitting diode colonoscopy for comparing large colorectal lesion visibility with linked color imaging and white-light imaging.

OBJECTIVES: In light-emitting diode (LED) and laser colonoscopy, linked color imaging (LCI) superiority to white-light imaging (WLI) for polyp detection is shown separately. We analyzed the noninferiority of LCI between LED and laser colonoscopy and that of WLI (LECOL study). METHODS: We prospectively collected nonpolypoid lesions with WLI and LCI using LED and laser colonoscopy from January 2021 to August 2021. All images were evaluated randomly by 12 endoscopists (six nonexperts and six experts in three institutions) using the polyp visibility score: 4, excellent; 3, good; 2, fair; and 1, poor. The comparison score (LED better/similar/laser better) for redness and brightness was evaluated for WLI and LCI pictures of each lesion. RESULTS: Finally, 63 nonpolypoid lesions were evaluated, and the mean polyp size was 24.5 ± 13.4 mm. Histopathology revealed 13 serrated lesions and 50 adenomatous/cancerous lesions. The mean polyp visibility scores of LCI pictures were significantly higher than those of WLI in the LED (3.35 ± 0.85 vs. 3.08 ± 0.91, P < 0.001) and the laser (3.40 ± 1.71 vs. 3.05 ± 0.97, P < 0.001) group, and the noninferiority of LCI pictures between LED and laser was significant (P < 0.001). The comparison scores revealed that the evaluation of redness and brightness (LED better/similar/laser better) were 26.8%/40.1%/33.1% and 43.5%/43.5%/13.0% for LCI pictures (P < 0.001) and 20.6%/44.3%/35.1% and 60.3%/31.7%/8.0% for WLI pictures (P < 0.001), respectively. CONCLUSION: The noninferiority of polyp visibility with WLI and LCI in LED and laser colonoscopy was shown. WLI and LCI of LED tended to be brighter and less reddish than those of laser.

Underwater Endoscopic Mucosal Resection of Small Rectal Neuroendocrine Tumors.

Background and Study Aims: The resection strategy for rectal neuroendocrine tumors (NET) < 10 mm is not uniform. We compared the utility of underwater endoscopic mucosal resection (UEMR) to endoscopic submucosal resection with a ligation device (ESMR-L) to resect rectal NETs. Patients and Methods: Patients with rectal NET < 10 mm treated with UEMR or ESMR-L were included. Their medical records were retrospectively reviewed. Results: Thirty-two patients were divided into a UEMR group (n = 7) and an ESMR-L group (n = 25). Histopathological diagnosis of NET by biopsy was known before resection in 43% (3/7) in the UEMR group and 68% (17/25) in the ESMR-L group, (p = 0.379). UEMR was performed on an outpatient basis for all patients, and 92% of ESMR-L (23/25) were performed as inpatient procedures (p < 0.001). The procedure time was significantly shorter in the UEMR group than in the ESMR-L group [median (IQR), min, 6 (5-8) vs. 12 (9-14), p = 0.002]. En bloc resection and R0 resection rates were 100% in both groups. Pathological evaluations were predominantly NET G1 in both groups (UEMR: 7/7, 100% and ESMR-L: 23/25, 92%). Two patients in the ESMR-L group developed delayed bleeding, controlled by endoscopic hemostasis. Device costs were significantly higher in the ESMR-L group than the UEMR group by approximately US$180 [median (IQR), $90.45 (83.64-108.41) vs. $274.73 (265.86-292.45), P < 0.001]. Conclusion: UEMR results in similar resection quality with shorter procedure time and lower costs compared to ESMR-L. We recommend UEMR for the resection of rectal NET < 10 mm.

Low prevalence of SARS-CoV-2 specific antibodies among endoscopists and their assistants in a university hospital in Tochigi prefecture-A single-center study.

Objectives: Gastrointestinal endoscopic procedures have a risk to transmit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) through aerosols. Little information is available on the seroprevalence of SARS-CoV-2 antibodies among healthcare workers (HCWs) in endoscopy units. Thus, the seroprevalence was examined in HCWs who do and do not participate in gastrointestinal endoscopy. Methods: A total of 382 HCWs at Jichi Medical University Hospital were enrolled in this study through March 2021. Among 382 HCWs, 63 are in the endoscopy unit. Serum antibody levels against SARS-CoV-2 were determined by immunochromatography, chemiluminescent immunoassay (CLIA), electric CLIA (ECLIA), and chemiluminescence microparticle immunoassay (CMIA). HCWs in the endoscopy unit underwent testing up to three times. We defined antibody-positive as when at least one test was positive. Results: The seroprevalence of SARS-CoV-2 antibodies in 63 HCWs in the endoscopy unit was 0%-1.9%, 0%-1.7%, and 0%-1.7% during the first (Ap-May 2020), second (Jun-Nov 2020), and third intervals (Dec 2020-Mar 2021), respectively. This seroprevalence was comparable to that of other HCWs not involved with gastrointestinal endoscopy. Two HCWs in the endoscopy unit were positive for antibodies: one was ECLIA-positive and the another was CMIA-positive. The ECLIA-positive HCW was PCR negative and converted to negative for the second and third tests. Another HCW was CMIA-positive at all three evaluations and the titers were unchanged. No HCWs in the endoscopy unit contracted a SARS-CoV-2 infection. Conclusions: The seroprevalence of SARS-CoV-2 antibodies was low among HCWs in the endoscopy unit through March 2021 (UMIN000039997).

Colorectal endoscopic submucosal dissection using the pocket-creation method with single clip traction: a feasibility study.

Background and study aims The pocket-creation method (PCM) facilitates dissection of the central part of a tumor. We previously developed the PCM with clip traction (PCM-CT) to facilitate opening the mucosal pocket, which otherwise could become cumbersome. In the present study, we aimed to examine the feasibility of PCM-CT for colorectal endoscopic submucosal dissection (ESD). Patients and methods PCM-CT was performed on 30 patients with early colorectal tumors from October 2019 to April 2020. PCM-CT allows efficient opening of the mucosal pocket by using the PCM to dissect the center of the lesion and then apply traction with a single clip after making a circumferential mucosal incision. Results The median specimen major axis length, ESD time, ESD speed, and en bloc resection rate were 48 mm, 84 minutes, 20 mm 2 /min, and 100 % (30/30), respectively. The success rates for the traction clip and median single-clip-traction time were 100 % (30/30) and 1.5 minutes, respectively. Conclusions Colorectal ESD using PCM-CT is a simple and promising method.

Double-balloon endoscopy facilitates efficient endoscopic resection of duodenal and jejunal polyps in patients with familial adenomatous polyposis.

BACKGROUND : Many patients with familial adenomatous polyposis (FAP) have adenomatous polyps of the duodenum and the jejunum. We aimed to elucidate the long-term outcomes after double-balloon endoscopy (DBE)-assisted endoscopic resection of duodenal and jejunal polyps in patients with FAP. METHODS : We retrospectively reviewed patients who underwent more than two sessions of endoscopic resection using DBE from August 2004 to July 2018. RESULTS : A total of 72 DBEs were performed in eight patients (median age 30 years, range 12-53; 1.4 DBE procedures/patient-year) during the study period, and 1237 polyps were resected. The median observation period was 77.5 months (range 8-167). There were 11 adverse events, including seven delayed bleeds and four episodes of acute pancreatitis. No delayed bleeding occurred after cold polypectomy. Although, in one patient, one endoscopically resected duodenal polyp was diagnosed as being intramucosal carcinoma, none of the patients developed an advanced duodenal or jejunal cancer during the study period. CONCLUSIONS : Endoscopic resection of duodenal and jejunal polyposis using DBE in patients with FAP can be performed safely, efficiently, and effectively.

Endoscopic ischemic polypectomy for small-bowel polyps in patients with Peutz-Jeghers syndrome.

BACKGROUND: To decrease the risk of bleeding or perforation, ischemic polypectomy is performed using a detachable snare or endoclip with double-balloon endoscopy (DBE) for small-bowel polyps in patients with Peutz - Jeghers syndrome. The aim of this study was to determine the effectiveness and feasibility of ischemic polypectomy. METHODS: We retrospectively reviewed patients who underwent two or more sessions of ischemic polypectomy using DBE from July 2004 to August 2017. RESULTS: 67 therapeutic DBEs were performed in nine patients during the study period and 352 polyps were treated. The median observation period was 34 months (range 12 - 66). There was a declining trend over time in the median number of polyps > 15 mm treated per patient first DBE session 6, second 2, third 1.5, fourth 0.5, fifth 0.5; P = 0.11, Friedman test). No patient required laparotomy due to intussusception during the study period. One patient developed mild acute pancreatitis after the procedure. CONCLUSIONS: Ischemic polypectomy was feasible for the control of small-bowel polyps in patients with Peutz - Jeghers syndrome.

The pocket-creation method may facilitate endoscopic submucosal dissection of large colorectal sessile tumors.

Background and study aims Resecting large colorectal sessile tumors using endoscopic submucosal dissection (ESD) is challenging because of severe submucosal fibrosis. Previously, we reported that ESD strategy using the pocket-creation method (PCM) is useful for large colorectal sessile tumors, but there are no large studies reporting the effectiveness and safety of the PCM for resection of large colorectal sessile tumors. Patients and methods This was a retrospective review of 90 large colorectal sessile tumors in 89 patients who underwent ESD in our institution. Large colorectal sessile tumors were defined as polypoid lesions 20 mm or more in diameter. We divided them into PCM (n = 40) and conventional method (CM) groups (n = 50). The primary outcome measure was en bloc resection. The inverse-probability-treatment weighting (IPTW) approach was used to adjust for selection bias. Results Both PCM and CM achieved high en bloc resection (100 % vs. 94 %, non-adjusted P  = 0.25, IPTW-adjusted P  = 0.19) and R0 resection rates (88 % vs. 78 %, non-adjusted P  = 0.28, IPTW-adjusted P  = 0.27). When PCM was used, the rate of pathologically negative vertical margins was significantly greater than with the CM (IPTW-adjusted P  = 0.045). The dissection time was significantly shorter (IPTW-adjusted P  = 0.025) and dissection speed faster (IPTW-adjusted P  = 0.013) using the PCM than when the CM was used. There was no significant difference in the incidence of adverse events (intraprocedural perforation and delayed bleeding, IPTW-adjusted P  = 0.68). Conclusion Although en bloc resection and R0 resection rates were similar, PCM significantly increased the rate of negative vertical margins with rapid dissection for treatment of large colorectal sessile tumors.

TH1 cell-inducing Escherichia coli strain identified from the small intestinal mucosa of patients with Crohn's disease.

Dysbiotic microbiota contributes to the pathogenesis of Crohn's disease (CD) by regulating the immune system. Although pro-inflammatory microbes are probably enriched in the small intestinal (SI) mucosa, most studies have focused on fecal microbiota. This study aimed to examine jejunal and ileal mucosal specimens from patients with CD via double-balloon enteroscopy. Comparative microbiome analysis revealed that the microbiota composition of CD SI mucosa differs from that of non-CD controls, with an increased population of several families, including Enterobacteriaceae, Ruminococcaceae, and Bacteroidaceae. Upon anaerobic culturing of the CD SI mucosa, 80 bacterial strains were isolated, from which 9 strains representing 9 distinct species (Escherichia coli, Ruminococcus gnavus, Klebsiella pneumoniae, Erysipelatoclostridium ramosum, Bacteroides dorei, B. fragilis, B. uniformis, Parabacteroides distasonis, and Streptococcus pasteurianus) were selected on the basis of their significant association with CD. The colonization of germ-free (GF) mice with the 9 strains enhanced the accumulation of TH1 cells and, to a lesser extent, TH17 cells in the intestine, among which an E. coli strain displayed high potential to induce TH1 cells and intestinal inflammation in a strain-specific manner. The present results indicate that the CD SI mucosa harbors unique pro-inflammatory microbiota, including TH1 cell-inducing E. coli, which could be a potential therapeutic target.

Prospective randomized trial comparing the pocket-creation method and conventional method of colorectal endoscopic submucosal dissection.

BACKGROUND AND AIMS: Colorectal endoscopic submucosal dissection (ESD) is recognized as a challenging procedure. Previously, we reported that a new ESD strategy using the pocket-creation method (PCM) is useful for colorectal ESD, but no prospective randomized study has evaluated the efficacy of the PCM. The aim of this study was to evaluate the efficacy and safety of PCM for colorectal ESD compared with the conventional method (CM). METHODS: This was a prospective randomized controlled trial at 3 institutions in Japan. Patients with superficial colorectal neoplastic lesions >20 mm predicted to be intramucosal were randomly assigned to undergo ESD using the PCM or CM. Primary outcome was the ESD completion rate defined as completion of colorectal ESD with an en bloc resection using the assigned ESD method without changing to other methods or assisted by other devices. RESULTS: We analyzed 59 patients with 59 colorectal tumors in the PCM group and 55 in the CM group. The ESD completion rate was significantly higher in the PCM group compared with the CM group (93% [55/59] vs 73% [40/55]; P  = .01). En bloc resection rates, R0 resection rates, procedure time, and dissection speed were not significantly different between the 2 groups. The incidence of adverse events was similar in the 2 groups. CONCLUSIONS: Use of the PCM allows the endoscopist to complete the procedure with the intended method more often than the CM with similar clinical outcomes. (Clinical trial registration number: UMIN 000024394.).

Recurrent intestinal inflammation with a perianal abscess is not always Crohn's disease: a patient with a complex Meckel's diverticulum diagnosed by double-balloon endoscopy.

Recurrent intestinal inflammation and refractory perianal abscesses are typical manifestations of Crohn's disease. However, these conditions are not always due to Crohn's disease. A 25-year-old male with recurrent perianal abscesses for 1 year, suspected to be due to Crohn's disease, was referred for further evaluation. Computed tomography scan showed a perianal abscess abutting the small intestine. A complicated Meckel's diverticulum was suspected based on these findings. Meckel's diverticulum scintigraphy was negative. Bidirectional double-balloon endoscopy (DBE) identified a long diverticulum in the ileum. In this long diverticulum, a tight stricture was seen 5 cm distal to the diverticular opening. A selective contrast study showed a 10 cm diverticulum distal to the stricture, with three strictures in the long diverticulum. Inflammation of the Meckel's diverticulum due to bacterial overgrowth was suspected as a cause of the refractory perianal abscesses. Laparoscopic diverticulectomy was performed, and the specimen showed a 10 cm diverticulum containing post-inflammatory changes with scar formation. The perianal abscess was confirmed to be caused by an inflamed Meckel's diverticulum. The patient has been asymptomatic for 6 years after resection. DBE before exploratory laparotomy should be considered to investigate the cause of an abscess that could be secondary to small intestinal pathology.

Colon polyp detection using linked color imaging compared to white light imaging: Systematic review and meta-analysis.

BACKGROUND AND AIM: Linked color imaging (LCI) is a novel image-enhancing technology which enhances color differences between a colorectal lesion and surrounding mucosa with enough brightness to illuminate the wide colorectal lumen. The aim of this study is to compare colorectal polyp detection using LCI with that using white light imaging (WLI). METHODS: Randomized controlled trials and prospective studies comparing LCI with WLI for colorectal polyp detection were selected. Outcomes included overall polyp/adenoma detection and additional polyp detection at a second observation. Outcomes were documented by pooled risk ratios (RR) with 95% confidence interval (CI) using the Mantel-Haenszel random effect model. RESULTS: Seven studies were included. LCI showed significant superiority for polyp and adenoma detection compared with WLI (RR 1.16, 95% CI 1.09-1.25, P < 0.001 for polyp detection; RR 1.26, 95% CI 1.14-1.39 P < 0.001 for adenoma detection). LCI significantly increased the number of polyps detected per patient compared with WLI (mean difference 0.27, 95% CI 0.01-0.53, P = 0.040). LCI significantly increased the number of adenomas detected per patient compared with WLI (mean difference 0.22, 95% CI 0.08-0.36, P = 0.002). LCI significantly increased the number of flat polyps detected per patient compared with WLI (mean difference 0.14, 95% CI 0.01-0.27, P = 0.040). LCI had a significantly higher rate of additional polyp detection compared with WLI in the right colon (RR 2.68, 95% CI 1.71-4.19, P < 0.001). CONCLUSIONS: Linked color imaging has significantly greater polyp and adenoma detection rates and detection rate of previously missed polyps compared with WLI. We recommend the initial use of LCI for routine colonoscopy.