Background and Aim
Colorectal endoscopic submucosal dissection (ESD) remains challenging because of technical difficulties, long procedure time, and high risk of adverse events. To facilitate ...colorectal ESD, we developed traction‐assisted colorectal ESD using a clip and thread (TAC‐ESD) and conducted a randomized controlled trial to evaluate its efficacy.
Methods
Patients with superficial colorectal neoplasms (SCN) ≥20 mm were enrolled and randomly assigned to the conventional‐ESD group or to the TAC‐ESD group. SCN ≤50 mm were treated by two intermediates, and SCN >50 mm were treated by two experts. Primary endpoint was procedure time. Secondary endpoints were TAC‐ESD success rate (sustained application of the clip and thread until the end of the procedure), self‐completion rate by the intermediates, and adverse events.
Results
Altogether, 42 SCN were analyzed in each ESD group (conventional and TAC). Procedure time (median range) for the TAC‐ESD group was significantly shorter than that for the conventional‐ESD group (40 11–86 min vs 70 30–180 min, respectively; P < 0.0001). Success rate of TAC‐ESD was 95% (40/42). The intermediates’ self‐completion rate was significantly higher for the TAC‐ESD group than for the conventional‐ESD group (100% 39/39 vs 90% 36/40, respectively; P = 0.04). Adverse events included one intraoperative perforation in the conventional‐ESD group and one delayed perforation in the TAC‐ESD group.
Conclusion
Traction‐assisted colorectal endoscopic submucosal dissection reduced the procedure time and increased the self‐completion rate by the intermediates (UMIN000018612).
Data on endoscopic resection (ER) for superficial duodenal epithelial tumors (SDETs) are insufficient owing to their rarity. There are two main ER techniques for SDETs: endoscopic mucosal resection ...(EMR) and endoscopic submucosal dissection (ESD). In addition, modified EMR techniques, such as underwater EMR (UEMR) and cold polypectomy, are becoming popular. We conducted a large-scale retrospective multicenter study to clarify the detailed outcomes of duodenal ER.
Patients with SDETs who underwent ER at 18 institutions from January 2008 to December 2018 were included. The rates of en bloc resection and delayed adverse events (AEs; defined as delayed bleeding or perforation) were analyzed. Local recurrence was analyzed using the Kaplan-Meier method.
In total, 3107 patients (including 1017 undergoing ESD) were included. En bloc resection rates were 79.1 %, 78.6 %, 86.8 %, and 94.8 %, and delayed AE rates were 0.5 %, 2.2 %, 2.8 %, and 6.8 % for cold polypectomy, UEMR, EMR and ESD, respectively. The delayed AE rate was significantly higher in the ESD group than in non-ESD groups for lesions < 19 mm (7.4 % vs. 1.9 %;
< 0.001), but not for lesions > 20 mm (6.1 % vs. 7.1 %;
= 0.64). The local recurrence rate was significantly lower in the ESD group than in the non-ESD groups (
< 0.001). Furthermore, for lesions > 30 mm, the cumulative local recurrence rate at 2 years was 22.6 % in the non-ESD groups compared with only 1.6 % in the ESD group (
< 0.001).
ER outcomes for SDETs were generally acceptable. ESD by highly experienced endoscopists might be an option for very large SDETs.
Endoscopic submucosal dissection (ESD) is widely used as a minimally invasive treatment for large esophageal cancers, but prolonged procedure duration and life-threatening adverse events remain ...matters of concern. We aimed to determine whether traction-assisted ESD (TA-ESD) is superior to conventional ESD in terms of technical outcomes.
A superiority, randomized, phase III trial was conducted at 7 institutions across Japan. Patients with large esophageal cancer (defined as tumor diameter >20 mm) were eligible for this study. Enrolled patients were randomly assigned to undergo conventional ESD or TA-ESD. The primary endpoint was ESD procedure duration.
Two hundred forty-one patients were recruited and randomized. On applying exclusion criteria, 117 and 116 patients who underwent conventional ESD and TA-ESD, respectively, were included in the baseline analysis. In 1 patient, conventional ESD was discontinued because of severe perforation. Thus, the final analysis included 116 patients per group (primary analysis). The ESD procedure duration was significantly shorter for TA-ESD than for conventional ESD (44.5 minutes vs 60.5 minutes, respectively; P < .001). Moreover, no adverse events were noted in the TA-ESD group. The rate of horizontal margin involvement did not differ between the groups (10.3% vs 6.9% for conventional ESD and TA-ESD, respectively; P = .484).
TA-ESD was superior to conventional ESD in terms of procedure duration and was not associated with any adverse events. TA-ESD should be considered the procedure of choice for large esophageal cancers. (Clinical trial registration number: UMIN000024080.)
The aim of this study was to clarify whether dental floss clip (DFC) traction improves the technical outcomes of endoscopic submucosal dissection (ESD).
A superiority, randomized control trial was ...conducted at 14 institutions across Japan. Patients with single gastric neoplasm meeting the indications of the Japanese guidelines for gastric treatment were enrolled and assigned to receive conventional ESD or DFC traction-assisted ESD (DFC-ESD). Randomization was performed according to a computer-generated random sequence with stratification by institution, tumor location, tumor size, and operator experience. The primary endpoint was ESD procedure time, defined as the time from the start of the submucosal injection to the end of the tumor removal procedure.
Between July 2015 and September 2016, 640 patients underwent randomization. Of these, 316 patients who underwent conventional ESD and 319 patients who underwent DFC-ESD were included in our analysis. The mean ESD procedure time was 60.7 and 58.1 minutes for conventional ESD and DFC-ESD, respectively (P = .45). Perforation was less frequent in the DFC-ESD group (2.2% vs .3%, P = .04). For lesions located in the greater curvature of the upper or middle stomach, the mean procedure time was significantly shorter in the DFC-ESD group (104.1 vs 57.2 minutes, P = .01).
Our findings suggest that DFC-ESD does not result in shorter procedure time in the overall patient population, but it can reduce the risk of perforation. When selectively applied to lesions located in the greater curvature of the upper or middle stomach, DFC-ESD provides a remarkable reduction in procedure time.
Underwater endoscopic mucosal resection (UEMR) was recently developed in a Western country. A prospective cohort study to investigate the effectiveness of UEMR was conducted in patients with small ...superficial nonampullary duodenal adenomas.
Patients with duodenal adenomas ≤ 20 mm were enrolled. After the duodenal lumen had been filled with physiological saline, UEMR was performed without submucosal injection. Endoclip closure was attempted for all mucosal defects after UEMR. Follow-up endoscopy with biopsy was performed 3 months later. The primary end point was the complete resection rate, defined as neither endoscopic nor histological residue of adenoma at the follow-up endoscopy.
30 patients with 31 lesions were enrolled. The mean (SD) tumor size was 12.0 mm (7.3). The complete resection rate was 97 % (90 % confidence interval, 87 % - 99 %). The en bloc resection rate was 87 %. All mucosal defects were successfully closed by endoclips. No adverse events occurred except for one case of mild aspiration pneumonia.
UEMR is efficacious for the treatment of small duodenal adenomas, but further large-scale trials are warranted to confirm these results.
Leucine-rich alpha-2 glycoprotein (LRG) may be a novel serum biomarker for patients with inflammatory bowel disease. The association of LRG with the endoscopic activity and predictability of mucosal ...healing (MH) was determined and compared with those of C-reactive protein (CRP) and fecal markers (fecal immunochemical test FIT and fecal calprotectin Fcal) in 166 ulcerative colitis (UC) and 56 Crohn's disease (CD) patients. In UC, LRG was correlated with the endoscopic activity and could predict MH, but the performance was not superior to that of fecal markers (areas under the curve AUCs for predicting MH: LRG: 0.61, CRP: 0.59, FIT: 0.75, and Fcal: 0.72). In CD, the performance of LRG was equivalent to that of CRP and Fcal (AUCs for predicting MH: LRG: 0.82, CRP: 0.82, FIT: 0.70, and Fcal: 0.88). LRG was able to discriminate patients with MH from those with endoscopic activity among UC and CD patients with normal CRP levels. LRG was associated with endoscopic activity and could predict MH in both UC and CD patients. It may be particularly useful in CD.
Background
Vonoprazan, potassium-competitive acid blocker, is expected to reduce incidence of delayed bleeding after gastric endoscopic submucosal dissection (ESD); however, preliminary data to ...design a large-scale comparative study are lacking. This study aimed to assess the efficacy of vonoprazan in preventing delayed bleeding after gastric ESD.
Methods
In this single-center randomized phase II trial, a modified screened selection design was used with a threshold non-bleeding rate of 89% and an expected rate of 97%. In this design, Simon’s optimal two-stage design was first applied for each parallel group, and efficacy was evaluated in comparison with the threshold rate using binomial testing. Patients were randomly assigned in a 1:1 ratio to receive either vonoprazan 20 mg (VPZ group) or lansoprazole 30 mg (PPI group) for 8 weeks from the day before gastric ESD. The primary endpoint was the incidence of delayed bleeding, defined as endoscopically confirmed bleeding accompanied by hematemesis, melena, or a decrease in hemoglobin of ≥ 2 g/dl.
Results
Delayed bleeding occurred in three of 69 patients (4.3%, 95% CI 0.9–12.2%,
p
= 0.047) in the VPZ group, and four of 70 (5.7%, 95% CI 1.6–14.0%,
p
= 0.104) in the PPI group. As only vonoprazan showed significant reduction in delayed bleeding compared with the threshold rate, it was determined to be efficacious treatment.
Conclusions
Vonoprazan efficaciously reduced the delayed bleeding rate in patients with an ESD-induced gastric ulcer. A large-scale, randomized, phase III study is warranted to definitively test the effectiveness of vonoprazan compared with proton pump inhibitors.
Objectives
Endoscopic biopsies for nonampullary duodenal epithelial neoplasms (NADENs) can induce submucosal fibrosis, making endoscopic resection difficult. However, no biopsy‐free method exists to ...distinguish between NADENs and non‐neoplasms. We developed a diagnostic algorithm for duodenal neoplasms based on magnifying endoscopy findings and evaluated the model's diagnostic ability.
Methods
Magnified endoscopic images and duodenal lesion histology were collected consecutively between January 2015 and April 2016. Diagnosticians classified the surface patterns as pit, groove or absent. In cases of nonvisible surface patterns, the vascular pattern was evaluated to determine regularity or irregularity. The correlation between our algorithm (pit‐type or absent with irregular vascular pattern) and the lesion histology were evaluated. Four evaluators, who were blinded to the histology, also classified the endoscopic findings and evaluated the diagnostic performance and interobserver agreement.
Results
Endoscopic images of 114 lesions were evaluated (70 NADENs and 44 non‐neoplasms, 31 in the superior and 83 in the descending and horizontal duodenum). Of the NADEN surface patterns, 88% (62/70) were pit‐type, while 79% (35/44) of the non‐neoplasm surface patterns were groove‐type. Our diagnostic algorithm for differentiating NADENs from non‐neoplasms was high (sensitivity 96%, specificity 95%) in the descending and horizontal duodenum. The evaluators’ diagnostic performances were also high, and interobserver agreement for the algorithm was good between each diagnostician and evaluator (κ = 0.60–0.76).
Conclusion
Diagnostic performance of our algorithm sufficiently enabled eliminating endoscopic biopsies for diagnosing the descending and horizontal duodenum.
Background and Aim
Underwater endoscopic mucosal resection (UEMR) is effective for superficial non‐ampullary duodenal epithelial neoplasms (SNADEN). However, the incidence of residual lesion after ...UEMR, especially for large lesions (≥20 mm), and their prognosis remain unclear. We aimed to assess the incidence of residual lesions and further outcomes after UEMR for SNADEN.
Methods
We carried out a retrospective study at a tertiary cancer institute. Candidates for the study were systematically retrieved from an endoscopic and pathological database from January 2013 to April 2018.
Results
A total of 162 SNADEN resected with UEMR were analyzed. Median (range) procedure time was 5 (1–70) min. En bloc resection rates for large lesions (≥20 mm) and small lesions (<20 mm) were 14% and 79%, respectively. Intraprocedural bleeding occurred in one (0.6%) case, but no intraprocedural perforation occurred during the study. Delayed bleeding occurred in two (1.2%) cases and delayed perforation occurred in one (0.6%) case. A total of 157 (97%) lesions were followed up by at least one endoscopic examination. Of these lesions, residual lesions were recognized in seven cases (5%). Additional UEMR was carried out in five lesions and underwater cold snare polypectomy in one lesion. One lesion was observed without additional treatment. After salvage intervention, no cases experienced further residual lesions.
Conclusion
Although UEMR for SNADEN can be relevant when other efficacious procedures are unavailable, careful follow up for residual lesions is required especially after piecemeal resection for large lesions.
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