Efficacy of polyglycolic acid sheeting with fibrin glue for perforations related to gastrointestinal endoscopic procedures: a multicenter retrospective cohort study.

OBJECTIVES: Gastrointestinal (GI) perforations are one of the major adverse events of endoscopic procedures. Polyglycolic acid (PGA) sheets with fibrin glue have been reported to close GI perforations. However, its clinical outcome has not yet been fully investigated; thus, we conducted a multicenter retrospective observational study to assess the efficacy of PGA sheeting for GI perforation. METHODS: The medical records of patients who underwent PGA sheeting for endoscopic GI perforations between April 2013 and March 2018 in 18 Japanese institutions were retrospectively analyzed. PGA sheeting was applied when the clip closure was challenging or failed to use. Perforations were filled with one or several pieces of PGA sheets followed by fibrin glue application through an endoscopic catheter. Nasal or percutaneous drainage and endoscopic clipping were applied as appropriate. Clinical outcomes after PGA sheeting for intraoperative or delayed perforations were separately evaluated. RESULTS: There were 66 intraoperative and 24 delayed perforation cases. In intraoperative cases, successful closure was attained in 60 cases (91%). The median period from the first sheeting to diet resumption was 6 days (interquartile range [IQR], 4-8.8 days). Large perforation size (≥ 10 mm) and duodenal location showed marginal significant relationship to higher closure failure of intraoperative perforations. In delayed perforation cases, all cases had successful closure. The median period from the first sheeting to diet resumption was 10 days (IQR, 6-37.8 days). No adverse events related to PGA sheeting occurred. CONCLUSION: Endoscopic PGA sheeting could be a therapeutic option for GI perforations related to GI endoscopic procedures.

Efficacy of Endoscopic Resection and Selective Chemoradiotherapy for Stage I Esophageal Squamous Cell Carcinoma.

BACKGROUND & AIMS: Esophagectomy is the standard treatment for stage I esophageal squamous cell carcinoma (ESCC). We conducted a single-arm prospective study to confirm the efficacy and safety of selective chemoradiotherapy (CRT) based on findings from endoscopic resection (ER). METHODS: We performed a prospective study of patients with T1b (SM1-2) N0M0 thoracic ESCC from December 2006 through July 2012; 176 patients underwent ER. Based on the findings from ER, patients received the following: no additional treatment for patients with pT1a tumors with a negative resection margin and no lymphovascular invasion (group A); prophylactic CRT with 41.4 Gy delivered to locoregional lymph nodes for patients with pT1b tumors with a negative resection margin or pT1a tumors with lymphovascular invasion (group B); or definitive CRT (50.4 Gy) with a 9-Gy boost to the primary site for patients with a positive vertical resection margin (group C). Chemotherapy comprised 5-fluorouracil and cisplatin. The primary end point was 3-year overall survival in group B, and the key secondary end point was 3-year overall survival for all patients. If lower limits of 90% confidence intervals for the primary and key secondary end points exceeded the 80% threshold, the efficacy of combined ER and selective CRT was confirmed. RESULTS: Based on the results from pathology analysis, 74, 87, and 15 patients were categorized into groups A, B, and C, respectively. The 3-year overall survival rates were 90.7% for group B (90% confidence interval, 84.0%-94.7%) and 92.6% in all patients (90% confidence interval, 88.5%-95.2%). CONCLUSIONS: In a prospective study of patients with T1b (SM1-2) N0M0 thoracic ESCC, we confirmed the efficacy of the combination of ER and selective CRT. Efficacy is comparable to that of surgery, and the combination of ER and selective CRT should be considered as a minimally invasive treatment option. UMIN-Clinical Trials Registry no.: UMIN000000553.

Differentiation between duodenal neoplasms and non-neoplasms using magnifying narrow-band imaging - Do we still need biopsies for duodenal lesions?

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.

Endoscopic Balloon Dilation Followed By Intralesional Steroid Injection for Anastomotic Strictures After Esophagectomy: A Randomized Controlled Trial.

OBJECTIVE: Endoscopic balloon dilation (EBD) is a standard treatment for anastomotic strictures after esophagectomy, and requires multiple dilations. We conducted a randomized controlled trial to assess the efficacy of adding a steroid injection to EBD to reduce restricture. METHODS: Patients were randomized to receive EBD combined with either triamcinolone or placebo injection. The primary endpoint was the number of dilations required to resolve the stricture. The secondary endpoints were restricture-free survival and adverse events. Patients with a dysphagia symptom score of ≥2 after esophagectomy with an endoscopy-confirmed anastomotic stricture were included. A total of 50 mg of triamcinolone acetonide (50 mg/5 mL) or an identical volume of normal saline solution as a placebo was injected per site using a 25-gauge needle immediately after EBD. Both the patient and treating physician were blinded to the treatment given. RESULTS: During the 4-year study period, 65 patients were randomized to either the steroid group (n = 33) or placebo group (n = 32). The median number of EBDs required to resolve strictures was 2.0 (interquartile range, 1.0-2.5) in the steroid group and 4.0 (interquartile range, 2.0-6.8) in the placebo group (p < 0.001). After 6 months of follow-up, 39% of patients who had received steroid injections remained recurrence free compared with 16% of those who had received saline injections (p = 0.002). No adverse events occurred during follow-up. CONCLUSIONS: Steroid injection shows promising results for the prevention of stricture recurrence in patients who underwent EBD for anastomotic strictures.

Underwater endoscopic mucosal resection for superficial nonampullary duodenal adenomas.

BACKGROUND AND STUDY AIM: 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 AND METHODS: 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. RESULTS: 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. CONCLUSIONS: UEMR is efficacious for the treatment of small duodenal adenomas, but further large-scale trials are warranted to confirm these results.

Safety of cold snare polypectomy for duodenal adenomas in familial adenomatous polyposis: a prospective exploratory study.

BACKGROUND: Cold snare polypectomy (CSP) to remove multiple duodenal adenomas (MDAs) in patients with familial adenomatous polyposis (FAP) could be an effective and less invasive method than more extensive surgery. The aim of the present study was to determine the safety of this procedure. METHODS: This prospective exploratory study included 10 consecutive patients with FAP and MDAs who underwent CSP for as many as 50 duodenal adenomas. The primary outcome was the incidence of severe adverse events. RESULTS: 10 patients were enrolled and underwent 332 CSPs from June 2016 to January 2017. The median procedure time was 33 minutes (range 25 - 53), and the median number of polyps removed during a single session was 35 (range 10 - 50). Most of the removed polyps were ≤ 10 mm. None of the 10 patients experienced a severe adverse event. One patient developed arterial bleeding during the procedure, but it was easily managed using hemoclips. CONCLUSIONS: CSP for MDAs in patients with FAP was safe. The long-term efficacy of this procedure should be investigated.

Efficacy of traction-assisted colorectal endoscopic submucosal dissection using a clip-and-thread technique: A prospective randomized study.

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).

Line-assisted complete closure for a large mucosal defect after colorectal endoscopic submucosal dissection decreased post-electrocoagulation syndrome.

BACKGROUND AND AIM: The incidence of post-endoscopic submucosal dissection (ESD) coagulation syndrome (PECS) can be decreased by closing mucosal defects. However, large mucosal defects after colorectal ESD cannot be closed endoscopically. We established line-assisted complete clip closure (LACC), a novel technique for large mucosal defects after colorectal ESD. We evaluated the prophylactic efficacy of LACC for preventing PECS. METHODS: Sixty-one consecutive patients on whom LACC after colorectal ESD was attempted from January 2016 to August 2016 were analyzed. After exclusion of patients with incomplete LACC and adverse events during ESD, 57 patients comprised the LACC group. In contrast, 495 patients who did not undergo closure of a mucosal defect comprised the control group. Propensity score matching was used to adjust for patients' backgrounds. Treatment outcomes were evaluated between the groups. RESULTS: Median resected specimen size in the LACC-attempted group was 35 mm (range, 20-72 mm), and LACC success rate was 95% (58/61). Median procedure time of LACC was 14 min. In the LACC group, incidence of PECS was only 2%, and no delayed bleeding or perforation occurred. Propensity score matching created 51 matched pairs. Adjusted comparisons between the LACC and control groups showed a lower incidence of PECS (0% vs 12%, respectively; P = 0.03) and shorter hospitalization (5 vs 6 days, respectively; P < 0.001) in the LACC group. CONCLUSION: This study suggests that LACC can effectively reduce the incidence of PECS, although further large-scale studies are warranted.

Incomplete resection rate of cold snare polypectomy: a prospective single-arm observational study.

Background and study aims Cold snare polypectomy (CSP) is considered to be safe for the removal of subcentimeter colorectal polyps. This study aimed to determine the rate of incomplete CSP resection for subcentimeter neoplastic polyps at our center. Patients and methods Patients with small or diminutive adenomas (diameter 1 - 9 mm) were recruited to undergo CSP until no polyp was visible. After CSP, a 1 - 3 mm margin around the resection site was removed using endoscopic mucosal resection. The polyps and resection site marginal specimens were microscopically evaluated. Incomplete resection was defined as the presence of neoplastic tissue in the marginal specimen. We also calculated the frequency at which the polyp lateral margins could be assessed for completeness of resection. Results A total of 307 subcentimeter neoplastic polyps were removed from 120 patients. The incomplete resection rate was 3.9 % (95 % confidence interval [CI] 1.7 % - 6.1 %); incomplete resection was not associated with polyp size, location, morphology, or operator experience. The polyp lateral margins could not be assessed adequately for 206 polyps (67.1 %). Interobserver agreement between incomplete resection and lateral polyp margins that were inadequate for assessment was poor (κ = 0.029, 95 %CI 0 - 0.04). Female sex was an independent risk factor for incomplete resection (odds ratio 4.41, 95 %CI 1.26 - 15.48; P  = 0.02). Conclusions At our center, CSP resection was associated with a moderate rate of incomplete resection, which was not associated with polyp characteristics. However, adequate evaluation of resection may not be routinely possible using the lateral margin from subcentimeter polyps that were removed using CSP.Trial registered at University Hospital Medical Information Network (UMIN 000010879).

Endoscopic imaging modalities for diagnosing invasion depth of superficial esophageal squamous cell carcinoma: a systematic review and meta-analysis.

BACKGROUND: Diagnosis of cancer invasion depth is crucial for selecting the optimal treatment strategy in patients with gastrointestinal cancers. We conducted a meta-analysis to determine the utilities of different endoscopic modalities for diagnosing invasion depth of esophageal squamous cell carcinoma (SCC). METHODS: We conducted a comprehensive search of MEDLINE, Cochrane Central, and Ichushi databases to identify studies evaluating the use of endoscopic modalities for diagnosing invasion depth of superficial esophageal SCC. We excluded case reports, review articles, and studies in which the total number of patients or lesions was <10. RESULTS: Fourteen studies fulfilled our criteria. Summary receiver operating characteristic curves showed that magnified endoscopy (ME) and endoscopic ultrasonography (EUS) performed better than non-ME. ME was associated with high sensitivity and a very low (0.08) negative likelihood ratio (NLR), while EUS had high specificity and a very high (17.6) positive likelihood ratio (PLR) for the diagnosis of epithelial or lamina propria cancers. NLR <0.1 provided strong evidence to rule out disease, and PLR >10 provided strong evidence of a positive diagnosis. CONCLUSIONS: EUS and ME perform better than non-ME for diagnosing invasion depth in SCC. ME has a low NLR and is a reliable modality for confirming deep invasion of cancer, while EUS has a high PLR and can reliably confirm that the cancer is limited to the surface. Effective use of these two modalities should be considered in patients with SCC. TRIAL REGISTRATION: PROSPERO (International Prospective Register of Systematic Reviews); number 42015024462 .

Scissor-type knife significantly improves self-completion rate of colorectal endoscopic submucosal dissection: Single-center prospective randomized trial.

BACKGROUND AND AIM: Colorectal endoscopic submucosal dissection (C-ESD) is recognized as a difficult procedure. Recently, scissors-type knives were launched to reduce the difficulty of C-ESD. The aim of this study was to evaluate the efficacy and safety of the combined use of a scissors-type knife and a needle-type knife with a water-jet function (WJ needle-knife) for C-ESD compared with using the WJ needle-knife alone. METHODS: This was a prospective randomized controlled trial in a referral center. Eighty-five patients with superficial colorectal neoplasms were enrolled and randomly assigned to undergo C-ESD using a WJ needle-knife alone (Flush group) or a scissor-type knife-supported WJ needle-knife (SB Jr group). Procedures were conducted by two supervised residents. Primary endpoint was self-completion rate by the residents. RESULTS: Self-completion rate was 67% in the SB Jr group, which was significantly higher than that in the Flush group (39%, P = 0.01). Even after exclusion of four patients in the SB Jr group in whom C-ESD was completed using the WJ needle-knife alone, the self-completion rate was significantly higher (63% vs 39%; P = 0.03). Median procedure time among the self-completion cases did not differ significantly between the two groups (59 vs 51 min; P = 0.14). No fatal adverse events were observed in either group. CONCLUSIONS: In this single-center phase II trial, scissor-type knife significantly improved residents' self-completion rate for C-ESD, with no increase in procedure time or adverse events. A multicenter trial would be warranted to confirm the validity of the present study.

Pethidine hydrochloride is a better sedation method for pharyngeal observation by transoral endoscopy compared with no sedation and midazolam.

BACKGROUND AND AIM: Standard surveillance methods for pharyngeal cancer have not been established. We conducted a randomized controlled trial to investigate the best sedation method for pharyngeal observation using transoral endoscopy. METHODS: In total, 120 patients who underwent surveillance or diagnostic examinations for esophageal cancer were enrolled and divided equally into three groups (no sedation, midazolam, or pethidine hydrochloride). In the midazolam group, midazolam was given i.v. maintaining a Ramsay score of 3. In the pethidine group, pethidine hydrochloride (35 mg) given i.v. Seven sites in five pharyngeal regions were observed on insertion of the endoscope, and graded (0 = poor, 1 = good). After examination, the five pharyngeal regions were scored using a seven-point scale. Primary endpoint was the total score from the five pharyngeal regions. Secondary endpoints were the proportion of the perfect score using the seven-point scale, discomfort score, and adverse events. RESULTS: Mean total scores for the no sedation group, the midazolam group and the pethidine group were 5.7, 5.5, and 6.8, respectively (P < 0.0001). Proportion of patients with a perfect score for the no sedation group, the midazolam group and the pethidine group were 53%, 35%, and 89%, respectively (P < 0.0001). The pethidine group had better results than the other two groups. Discomfort score and adverse events were low in the pethidine group. CONCLUSION: Pethidine hydrochloride is a feasible and safe sedation method, and was superior to no sedation and midazolam regarding pharyngeal observation of esophageal cancer patients.

Features of electrocoagulation syndrome after endoscopic submucosal dissection for colorectal neoplasm.

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) is a promising treatment for large gastrointestinal superficial neoplasms, although it is technically difficult, and perforation and delayed bleeding are well-known adverse events. However, there have been no large studies about electrocoagulation syndrome after colorectal ESD. The aim of this study was to evaluate the incidence and clinical significant risk factors of post-ESD coagulation syndrome (PECS). METHODS: This was a retrospective cohort study conducted in a referral cancer center. A total of 336 patients with colorectal neoplasms (143 adenomas or serrated lesions and 193 carcinomas) underwent ESD from January 2011 to June 2013. Incidence, outcome, and factors associated with occurrence of PECS were investigated. RESULTS: Occurred in 32 patients (9.5%). The median time until PECS was 15.5 h, and the median period of PECS was 32.5 h. Fever (≥37.6 °C) after ESD was found in 41% of the PECS group and 9% of the non-PECS group (P < 0.001). All PECS cases were managed conservatively. On multivariate analysis, female patients (odds ratio [OR] = 3.2, P = 0.002), lesion location at ascending colon and cecum (OR = 3.5, P = 0.001), and resected specimen ≥40 mm (OR = 2.1, P = 0.05) were independent risk factors for PECS. CONCLUSIONS: Occurred in 32 patients (9.5%) with colorectal ESD; however, all cases had a good outcome with conservative management. Female sex, tumor location at the ascending colon and cecum, and resected specimen ≥40 mm were independently significant risk factors for PECS.

Feasibility of Simple Traction Technique for Rectal Endoscopic Submucosal Dissection.

BACKGROUND AND AIMS: Rectal endoscopic submucosal dissection (ESD) is a highly effective procedure that achieves high en bloc resection regardless of lesion size or location. However, rectal ESD has a higher risk of intraoperative and postoperative bleeding and still difficult for beginners. Therefore, we designed a novel traction technique "traction-assisted rectal ESD using a clip-with-line (TAREC)," and investigated its feasibility. METHODS: Between December 2014 and July 2015, ten patients with rectal neoplasms (median size 36 mm; range 20-125 mm) were treated using the TAREC technique. RESULTS: In all lesions, good visibility of the submucosal layer was obtained, and the submucosal layer was dissected easily under direct visualization. All lesions were removed en bloc, and there were no procedure-related adverse events including postoperative bleeding. In particular, we experienced no intraoperative bleeding, which may be difficult to stop in some circumstances. CONCLUSIONS: The TAREC technique is a simple and generally applicable procedure. This technique is feasible for rectal ESD.

Endoscopic submucosal dissection as minimally invasive treatment for superficial pharyngeal cancer: a phase II study (with video).

BACKGROUND AND AIMS: Although endoscopic submucosal dissection (ESD) has been applied for superficial pharyngeal cancer, no prospective trials have been reported. To investigate the efficacy and safety of ESD for superficial pharyngeal cancer, we conducted a prospective phase II trial. METHODS: Fifty-four patients with 73 lesions were enrolled from September 2010 to August 2014, and ESD was performed. The primary endpoint was the complete resection rate. Secondary endpoints were safety, recurrence-free survival, overall survival, and incidence of metachronous pharyngeal cancer. RESULTS: Fifty-four patients had stage 0-III cancer: stage 0, n = 22; stage I, n = 14; stage II, n = 17; and stage III, n = 1. The en bloc resection rate was 100%, and the complete resection rate was 79.5% (58/73 lesions; 95% confidence interval, 68%-88%). No serious adverse events related to ESD were encountered. Four patients required nasogastric intubation and feeding. No patients required percutaneous endoscopic gastrostomy and tracheotomy. Swallowing, speech, and airway functions were preserved in all patients. One of the 54 patients died of an unrelated illness. Median follow-up was 27 months (range 6-55 months). Local cervical lymph node metastasis was observed in 1 patient, and the case was salvaged successfully with lymph node dissection. The 3-year overall and recurrence-free survival rates were 97.7% and 98.1%, respectively. Cumulative development of multiple cancers of the pharynx at 3 years was 18.4%. CONCLUSIONS: ESD appears to be a safe and effective minimally invasive treatment in patients with superficial pharyngeal cancer. ( CLINICAL TRIAL REGISTRATION NUMBER: UMIN000003623.).

Diagnostic features of sessile serrated adenoma/polyps on magnifying narrow band imaging: a prospective study of diagnostic accuracy.

BACKGROUND AND AIMS: The narrow band imaging classification system (NBI International Colorectal Endoscopic [NICE] classification) classifies colorectal polyps very accurately. However, sessile serrated adenoma/polyps (SSA/Ps) pathologically resembles hyperplastic polyp and has a possibility to be left in situ on NICE classification. The aim of this study was to establish and evaluate new simple diagnostic features for SSA/Ps using magnifying narrow band imaging (M-NBI). METHODS: We performed a single-arm observational study of diagnostic accuracy in two stages, as follows: seeking stage, development of simple diagnostic features for SSA/P and definition of diagnostic criteria based on retrospective assessments of M-NBI; and validation stage, prospective validation and evaluation of the new diagnostic criteria. RESULTS: In the seeking stage, we identified brownish, oval, expanded crypt openings and thick-branched vessels on the surfaces of SSA/Ps. We named these "expanded crypt openings" (ECOs) and "thick and branched vessels" (TBVs), respectively. In the validation stage, we enrolled 796 polyps in 261 patients, and classified 126 polyps as NICE type 1; all these lesions were endoscopically removed and assessed histopathologically. The sensitivity, specificity, and accuracy of ECOs for SSA/Ps were 84.3%, 81.1%, and 82.4%, whereas those of TBVs were 45.1%, 68.9%, and 59.2%, respectively. M-NBI provided a sensitivity of 98% and specificity of 59.5% for discrimination of SSA/Ps from other lesions classified as NICE type 1. CONCLUSIONS: Identification of ECOs, supplemented with TBVs, has high sensitivity for the diagnosis of SSA/P. These findings may facilitate the use of endoscopic optical diagnosis in clinical practice.

A Phase III study of oral steroid administration versus local steroid injection therapy for the prevention of esophageal stricture after endoscopic submucosal dissection (JCOG1217, Steroid EESD P3).

A randomized Phase III trial commenced in Japan in September 2014. Endoscopic local steroid injection has been commonly used and considered acceptable as the current standard treatment for the prevention of esophageal stricture after endoscopic submucosal dissection for superficial esophageal cancer. The purpose of this study is to confirm the superiority of prophylactic oral steroid administration following endoscopic submucosal dissection in terms of stricture-free survival over endoscopic local steroid injection for patients with superficial esophageal cancer. A total of 360 patients will be accrued from 35 Japanese institutions within 2.5 years. The primary endpoint is stricture-free survival, and the secondary endpoints are the number of endoscopic balloon dilations for 12 weeks after endoscopic submucosal dissection, adverse events, serious adverse events and the proportion of patients with dysphagia score ≤1 at 12 weeks after endoscopic submucosal dissection. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000015064 (http://www.umin.ac.jp/ctr/index.htm).

A randomized controlled Phase II/III study comparing endoscopic balloon dilation combined with steroid injection versus radial incision and cutting combined with steroid injection for refractory anastomotic stricture after esophagectomy: Japan Clinical Oncology Group Study JCOG1207.

A randomized Phase II/III trial commenced in May 2014. Endoscopic balloon dilation with steroid injection is the current standard treatment for patients with refractory anastomotic stricture after esophagectomy. The purpose of this study is to confirm the superiority of radial incision and cutting with steroid injection in terms of both restricture-free survival and number of dilations within 24 weeks compared with endoscopic balloon dilation with steroid injection for these patients. A total of 130 patients will be accrued from 30 Japanese institutions over 3 years. The primary endpoint in the Phase II part is proportion of Grade 3/4 intraoperative hemorrhages, post-operative esophageal perforations, esophageal hemorrhages, pneumothorax, lung or mediastinum infections or other unexpected adverse events. Co-primary endpoints in the Phase III part are restricture-free survival and number of dilations within 24 weeks after treatment. Secondary endpoints are proportion of patients with anastomotic diameter >10 mm at 8 weeks after treatment, proportion of adverse events, proportion of patients experiencing improvement of dysphagia score at 2, 4, 8 and 24 weeks after treatment and proportion of patients with dysphagia score ≤1 at 24 weeks after treatment. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000014017 [http://www.umin.ac.jp/ctr/index.htm].

Endoscopic optical diagnosis provides high diagnostic accuracy of esophageal squamous cell carcinoma.

BACKGROUND: Recent technological advances have stimulated the development of endoscopic optical biopsy technologies. This study compared the accuracy of endoscopic diagnosis using magnifying narrow-band imaging (NBI) and histologic diagnosis of esophageal squamous lesions. METHODS: Patients at high risk for esophageal squamous cell carcinoma were examined with endoscopy and subsequent biopsy. The lesions diagnosed as cancer on NBI and the lesions diagnosed as cancer on biopsy were resected endoscopically or surgically. Histological diagnoses of resected specimens, the reference standards in this study, were made by a pathologist who was blind to both the endoscopic and biopsy diagnoses. The primary outcome was the accuracy of endoscopic and biopsy diagnosis. A noninferiority trial design with a noninferiority margin of -10% was chosen to investigate the accuracy of endoscopic diagnosis using magnifying NBI. RESULTS: Between November 2010 and October 2012, a total of 111 lesions in 85 patients were included in the analysis. The accuracy of endoscopic diagnosis and biopsy diagnosis for all lesions was 91.0% (101/111) and 85.6% (95/111), respectively. The difference in diagnostic accuracy was 5.4% (95% confidence interval: -2.9%-13.7%). The accuracy of endoscopic diagnosis and biopsy diagnosis of invasive cancers was 94.9% (74/78) and 84.6% (66/78), respectively. The difference was 10.3% (95% confidence interval: 1.6%-19.0%) for invasive cancers. The lower bound of the 95% confidence interval was above the prestated -10% in both cases. CONCLUSION: Noninferiority of endoscopic diagnosis by magnifying NBI to histologic diagnosis by biopsy was established in this study (p = 0.0001). TRIAL REGISTRATION: The study was registered on 9th November 2010 in the University Hospital Medical Network Clinical Trials Registry as number: UMIN000004529.

Proposal of a new 'resect and discard' strategy using magnifying narrow band imaging: pilot study of diagnostic accuracy.

BACKGROUND AND AIM: A 'resect and discard' strategy using non-magnifying narrow band imaging (N-NBI) has been proposed for reducing screening colonoscopy costs, but it does not take into consideration advanced histology and magnifying NBI (M-NBI) that can potentially further improve the 'resect and discard' strategy. We conducted a pilot study to investigate the feasibility of M-NBI for the new 'resect and discard' strategy with consideration for advanced histology. METHODS: The present study involved 63 patients. For each polyp, optical diagnosis was independently made using N-NBI and M-NBI, a decision (discard or send for pathology) was made based on the M-NBI findings, and histological and optical diagnosis results were compared. RESULTS: Sensitivity, specificity and accuracy (95% confidence interval) of M-NBI for lesions with advanced histology were 1.00 (0.36-1.00), 0.92 (0.91-0.92) and 0.92 (0.90-0.92), respectively. Whereas the management of 86% of small polyps could be decided without formal histopathology, lesions with advanced histology were not discarded using M-NBI. The diagnostic accuracy of M-NBI in distinguishing neoplastic from non-neoplastic lesions was higher than that of N-NBI. CONCLUSIONS: We propose a new resect and discard strategy with advanced histology using M-NBI that is a promising strategy to reduce the costs of histopathology and to minimize the risk of discarding important lesions.