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.

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.

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.

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.).

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.

The pocket-creation method facilitates colonic endoscopic submucosal dissection (with video).

BACKGROUND AND AIMS: Colonic endoscopic submucosal dissection (ESD) is more difficult than rectal ESD because of poor maneuverability of the endoscope due to physiologic flexion, peristalsis, and respiratory movements. The aim of this study was to assess the usefulness of the pocket-creation method (PCM) for colonic ESD compared with the conventional method (CM) regardless of lesion shape or location. METHODS: A total of 887 colorectal lesions were treated by ESD. Of 887 lesions, 271 rectal lesions, 72 lesions smaller than 20 mm in diameter, and 1 non-neoplastic lesion were excluded. This is a retrospective chart review of the remaining 543 colon lesions in 512 patients. We divided them into the PCM group (n = 280) and the CM group (n = 263). The primary outcome was the en bloc resection rate. Secondary outcomes were R0 resection (en bloc resection with negative margin), adverse events, dissection time (in minutes), and dissection speed (in mm2/min). RESULTS: The PCM group achieved a significantly higher en bloc resection rate (PCM, 100% [280/280], vs CM, 96% [253/263]; P < .001) and R0 resection rate (91% [255/280] vs 85% [224/263], respectively; P = .033) than the CM group. Dissection time was similar (69.5 ± 44.4 vs 78.7 ± 62.6 minutes, P = .676). Dissection speed was significantly faster with the PCM than with the CM (23.5 ± 11.6 vs 20.9 ± 13.6 mm2/min, P < .001). The incidence of adverse events was similar (perforation, 2% vs 4% [P = .152], and delayed bleeding, 2% vs 1% [P = .361]). CONCLUSIONS: Colonic ESD using the PCM significantly improves the rates of en bloc resection and R0 resection and facilitates rapid dissection.

Balloon-assisted endoscopy facilitates endoscopic submucosal dissection of difficult superficial proximal colon tumors.

BACKGROUND: Colorectal endoscopic submucosal dissection (ESD) can be technically difficult in some situations, such as paradoxical movement of the proximal colon. The double-balloon endoscope provides stable endoscopic maneuvering, even in the small intestine. The aim of this study was to assess the outcomes of balloon-assisted endoscopic submucosal dissection (BAESD) of colonoscopically difficult superficial proximal colon tumors. METHODS: We retrospectively reviewed the records of patients who underwent BAESD of superficial proximal colon tumors where colonoscopic difficulties were encountered, from January 2011 to September 2016. Difficulties were defined as a previous incomplete colonoscopy using a conventional colonoscope or unstable endoscopic maneuverability around the tumor with a conventional colonoscope. A propensity score model was used as a secondary analysis to compare outcomes of the BAESD group with those of a non-BAESD group.  RESULTS: BAESD was performed on 63 tumors in 63 patients. En bloc resection was achieved for 62 tumors (98 %) and an R0 resection was achieved for 55 tumors (87 %). Propensity score matching analysis created 59 matched pairs from the BAESD and non-BAESD groups. There were no statistically significant differences between the two groups in en bloc resection (100 % vs. 100 %; P > 0.99), R0 resection (90 % vs. 93 %; P = 0.74), perforation (0 % vs. 2 %; P > 0.99) or postoperative bleeding (3 % vs. 0 %; P = 0.50). CONCLUSION: Balloon-assisted endoscopy achieved safe and reliable ESD of colonoscopically difficult superficial proximal colon tumors.

Double-Balloon Colonoscopy Has a Higher Cecal Intubation Rate Than Conventional Colonoscopy Using a Colon Simulator.

BACKGROUND/AIM: Cecal intubation using conventional colonoscopy (CC) requires substantial training. We hypothesized that double-balloon colonoscopy (DBC) facilitates cecal intubation by endoscopy naïve operators. The aim of this study is to evaluate the cecal intubation rate and learning curve of DBC compared with CC. METHODS: Eighteen endoscopy naïve medical students were allocated to two groups and attempted cecal intubation within 20 min using a colon simulator. In group A, CC was performed ten times and then DBC ten times. In group B, the reverse was carried out. We evaluated the cecal intubation rate and learning curve. RESULTS: The overall success rate for cecal intubation using DBC was significantly superior to CC [132/180 (73%) vs. 12/180 (7%), p < 0.001]. To evaluate the success rate overtime, we divided the ten repetitions of the procedure into three time periods: first (1-3), second (4-6), and third (7-10). The success rate using CC is <20%, even during the third time period, in both groups, and one perforation occurred. The success rate using DBC is over 30% in the first period and increased to nearly 80% in the third period in both groups. Finally, we evaluated the time needed for cecal intubation using DBC. The mean cecal intubation time in the first period is 14 min and decreased to 11 min in the third period. CONCLUSIONS: DBC has a higher cecal intubation rate than CC performed by endoscopy naïve medical students using a colon simulator in this randomized-controlled, cross-over study.

Efficacy and safety of endoscopic submucosal dissection for superficial colorectal tumors more than 50 mm in diameter.

BACKGROUND AND AIMS: The feasibility of endoscopic submucosal dissection (ESD) for large superficial colorectal tumors is undefined. The aim of this study was to assess the outcomes for patients undergoing ESD of superficial colorectal tumors larger than 50 mm. METHODS: A total of 472 patients who underwent ESD for superficial colorectal tumors from 2010 to 2014 were enrolled. We retrospectively reviewed their records. RESULTS: We compared patients with 20-mm to 50-mm lesions and those with lesions >50 mm regarding demographics, the ESD procedure, and histopathology. Among patients with lesions >50 mm, laterally spreading tumors nongranular and protruded types were uncommon. Histopathologically, deeply invasive (≥1000 µm) submucosal carcinomas were more frequent in lesions >50 mm (14% [10/70] vs 5% [20/402], P < .01). Technically, en bloc resection was successfully accomplished in 99% of patients (69/70). Although the total dissection time for lesions >50 mm was significantly longer than for lesions 20 mm to 50 mm (mean ± SD, 157 ± 114 minutes vs 68 ± 50 min; P < .01), dissection speed for lesions >50 mm was significantly faster than for lesions 20 mm to 50 mm (P < .01). There were no significant differences in en bloc R0 resection rate comparing both groups (>50 mm, 83% vs 20 mm to 50 mm, 87%; P = .31). No perforations or postoperative bleeding occurred in patients with lesions >50 mm. Post-ESD colorectal strictures requiring intervention did not develop in any patient. CONCLUSIONS: ESD for superficial colorectal tumors >50 mm is feasible. ESD of these lesions had a high R0 resection rate and a low adverse event rate. En bloc resection by ESD provides adequate pathological specimens and may limit the need for surgical intervention.

Relationship between the degree of endoscopic atrophy of the gastric mucosa and carcinogenic risk.

BACKGROUND: The relationship between Helicobacter pylori infection and gastric cancer has been demonstrated, and the risk of gastric cancer occurrence is known to increase with the progression of atrophic changes associated with chronic gastritis. Endoscopic evaluation of the degree and extent of atrophy of the gastric mucosa is a simple and very important means of identifying a group at high risk for gastric cancer. This study aimed to clarify the carcinogenic risk in relation to the degree of atrophy. METHODS: A total of 27,777 patients (272 with early gastric cancer and 135 with advanced gastric cancer) were included in this study. Endoscopically evaluated atrophy of the gastric mucosa was classified as C-0 to O-3 according to the Kimura and Takemoto classification system. RESULTS: The cancer detection rate in relation to the degree of gastric mucosal atrophy was 0.04% (2/4,183 patients) for C-0, 0% (0/4,506) for C-1, 0.25% (9/3,660) for C-2, 0.71% (21/2,960) for C-3, 1.32% (75/5,684) for O-1, 3.70% (140/3,780) for O-2 and 5.33% (160/3,004) for O-3. As to the proportions of differentiated and undifferentiated cancers, the latter were relatively frequent in the C-0 to C-2 groups, but differentiated cancers became predominant as atrophy progressed. On the other hand, the number of both differentiated and undifferentiated cancers detected increased as gastric mucosal atrophy progressed. In addition, open-type atrophy was found in 29 (96.7%) of 30 patients with synchronous multiple gastric cancers and in all 20 patients with metachronous multiple gastric cancers. CONCLUSION: Endoscopic evaluation of gastric mucosal atrophy can provide a simple and reliable predictive index for both current and future carcinogenic risk.

Long-Term Outcomes in Patients with Overt Obscure Gastrointestinal Bleeding After Negative Double-Balloon Endoscopy.

BACKGROUND: The long-term outcomes of patients after negative double-balloon endoscopy (DBE) for obscure gastrointestinal (GI) bleeding remain unclear. AIM: The aim of this study was to assess the long-term outcomes of patients with negative DBE and clarify the effect of repeat endoscopic work-up. METHODS: A total of 42 patients with a negative DBE for overt obscure GI bleeding were enrolled, and their clinical data were retrospectively reviewed. The mean (± standard deviation) follow-up period is 5.4 (± 2.8) years. The outcome measurement was overt rebleeding witnessed by the patient after negative DBE. At the time of rebleeding, further endoscopic work-up and specific treatment were performed. RESULTS: Rebleeding occurred in 16 of 42 patients (38%). At the time of rebleeding, further investigations were made in 14 of 16 patients (88%), and the bleeding source was identified in 10 of 14 patients (71%). These 10 patients received specific treatment (endoscopic in five, surgical in two, medical in two, and angiographic in one). The bleeding source was in the small intestine in seven of 10 patients (70%). Blood transfusion before DBE and multiple bleeding episodes before DBE were significant predictive factors for rebleeding (odds ratio 5.056, 95% confidence interval 1.158-22.059, p = 0.031 and odds ratio 8.167, 95% confidence interval 1.537-43.392, p = 0.014, respectively). CONCLUSIONS: The rebleeding rate after a negative DBE is considerable. Careful long-term follow-up and repeat endoscopic work-up at the time of overt rebleeding are important.

Utility of a new reusable clip device for endoscopic treatment.

BACKGROUND AND AIM: Existing reusable endoscopic clip devices have some problems regarding opening the device and precise control of clip application. The aim of the present study was to evaluate reusable clip devices for endoscopic treatment. METHODS: Ability to close a large defect and grip force were evaluated using ex-vivo porcine colon. We assessed clip loading and opening in a non-clinical setting and describe the resulting learning curve. To evaluate clinical utility, data for clip application in 72 post-endoscopic mucosal resection (EMR) defects in 40 patients were retrospectively analyzed. RESULTS: There was no difference in the ability to close a 20-mm full-thickness defect and the grip force comparing the new clip device (ZEOCLIP®) and a previously used reusable clip device (EZClip®). Although the time to load the ZEOCLIP was almost same as the EZClip, the time to open the ZEOCLIP was significantly shorter than the EZClip (P < 0.001). Opening width of the ZEOCLIP was significantly wider than the EZClip (P < 0.05). We successfully accomplished closure of post-EMR defects by clip application in 72 lesions using ZEOCLIP. Reopening/repositioning and restoring it to the working channel were more frequently carried out in a non-easy location than in an easy location (11/35 [31%] vs 4/37 [11%], P = 0.030; and 21/35 [60%] vs 1/37 [3%], P < 0.001, respectively). CONCLUSIONS: ZEOCLIP is more quickly and easily opened to its maximum width compared with EZClip, and is feasible for clip application after EMR.

Favorable long-term outcomes of repeat endotherapy for small-intestine vascular lesions by double-balloon endoscopy.

BACKGROUND: GI bleeding secondary to small-intestine vascular lesions (SIVLs) is associated with rebleeding despite initial hemostasis by endotherapy applied at double-balloon endoscopy (DBE). OBJECTIVE: To evaluate the long-term outcomes of DBE endotherapy of SIVL (as described by the Yano-Yamamoto classification). The impact of repeat DBE endotherapy for recurrent bleeding also was assessed. DESIGN: Retrospective cohort study. The mean (± standard deviation [SD]) follow-up period was 4.9 (± 1.7) years (range 2.4-9.1 years). SETTING: Tertiary-care referral center. PATIENTS: A total of 43 patients, who underwent 69 sessions of DBE endotherapy of SIVLs. INTERVENTION: DBE endotherapy. MAIN OUTCOME MEASUREMENTS: Frequency of overt rebleeding after the initial DBE endotherapy. RESULTS: Overt rebleeding occurred in 16 of 43 patients (37%). Patients with multiple SIVLs showed a significantly higher rate of overt rebleeding than did those with a solitary SIVL (12/23 [52%] vs 4/20 [20%]; P = .017). The trend toward frequency of rebleeding after the first DBE hemostasis appeared to be higher for patients with type 1a SIVLs than for those with type 1b or type 2 lesions: type 1a (8/16, 50%) versus type 1b (5/19, 26%) (P = .12) and type 1a (8/16, 50%) versus type 2 (2/7, 29%) (P = .31), respectively. In 12 of 16 patients (75%) who underwent repeat DBE endotherapy at each episode of overt rebleeding (median 3 times, range 2-6), the frequency of rebleeding decreased significantly after the first year of follow-up, as compared with the remaining 4 patients who did not undergo repeat DBE; mean (± SD) 0.12 (± 0.19) versus 0.52 (± 0.33) times per year per patient (P = .006). LIMITATIONS: Single-center, retrospective study. CONCLUSION: Although the presence of multiple SIVLs was associated with rebleeding, repeat DBE endotherapy resulted in an improved long-term outcome in patients with refractory SIVL bleeding.

Endoscopic ultrasound with double-balloon endoscopy in the evaluation of small-bowel disease.

BACKGROUND: Double-balloon endoscopy (DBE) has become a new standard in enteroscopy. However, it may be difficult to make a diagnosis or plan treatment strategy with endoscopic visualization alone. The addition of endoscopic ultrasonography (EUS) has the potential to improve the ability to establish the diagnosis and develop a treatment strategy. The present study was conducted to assess the feasibility and usefulness of EUS with DBE. METHODS: EUS with DBE was performed in 31 of 891 patients who underwent DBE from July 2004 to March 2011 at Jichi Medical University Hospital. We analyzed the EUS findings for lesions and evaluated the usefulness of EUS considering the following three factors: qualitative diagnostic value for lesions, depth grading of lesions, and evaluation of the structure of severe strictures prior to endoscopic balloon dilation. RESULTS: EUS was performed for 31/32 lesions (97%) in 31 patients. EUS findings were informative for 29/32 lesions (91%). EUS findings were useful for establishing a qualitative diagnosis in 15/25 lesions (60%). EUS findings for depth grading provided useful information for determining the therapeutic strategy in 11/13 lesions (85%). EUS with DBE was useful in the evaluation of strictures for all six lesions (100%). The overall usefulness of EUS with DBE on decision making was 72% (23/32) in this study. CONCLUSIONS: EUS with DBE is feasible and useful. It provides additional information on small-bowel disease and contributes to establishing a precise diagnosis and selection of an appropriate therapeutic strategy.