Comparison of Effective Imaging Modalities for Detecting Gastric Neoplasms: A Randomized 3-Arm Phase II Trial.

INTRODUCTION: The early detection of gastric neoplasms (GNs) leads to favorable treatment outcomes. The latest endoscopic system, EVIS X1, includes third-generation narrow-band imaging (3G-NBI), texture and color enhancement imaging (TXI), and high-definition white-light imaging (WLI). Therefore, this randomized phase II trial aimed to identify the most promising imaging modality for GN detection using 3G-NBI and TXI. METHODS: Patients with scheduled surveillance endoscopy after a history of esophageal cancer or GN or preoperative endoscopy for known esophageal cancer or GN were randomly assigned to the 3G-NBI, TXI, or WLI groups. Endoscopic observations were performed to detect new GN lesions, and all suspected lesions were biopsied. The primary endpoint was the GN detection rate during primary observation. Secondary endpoints were the rate of missed GNs, early gastric cancer detection rate, and positive predictive value for a GN diagnosis. The decision rule had a higher GN detection rate between 3G-NBI and TXI, outperforming WLI by >1.0%. RESULTS: Finally, 901 patients were enrolled and assigned to the 3G-NBI, TXI, and WLI groups (300, 300, and 301 patients, respectively). GN detection rates in the 3G-NBI, TXI, and WLI groups were 7.3, 5.0, and 5.6%, respectively. The rates of missed GNs were 1.0, 0.7, and 1.0%, the detection rates of early gastric cancer were 5.7, 4.0, and 5.6%, and the positive predictive values for the diagnosis of GN were 36.5, 21.3, and 36.8% in the 3G-NBI, TXI, and WLI groups, respectively. DISCUSSION: Compared with TXI and WLI, 3G-NBI is a more promising modality for GN detection.

Prospective multicenter trial of the cryoballoon ablation system for superficial esophageal squamous cell carcinoma on the post-endoscopic resection scar. A CRYO-SCAR study (EPOC1902).

BACKGROUND AND AIMS: Endoscopic resection (ER) is a minimally invasive treatment for superficial esophageal squamous cell carcinoma (SESCC). Post-ER scars complicate en bloc resection, even with advanced techniques, such as endoscopic submucosal dissection. The cryoballoon ablation system (CBAS) effectively manages Barrett's esophagus but has limited evidence in SESCC treatment, particularly on post-ER scars. This study aimed to evaluate the efficacy and safety of the CBAS for treating SESCC on post-ER scars. METHODS: This prospective study was conducted at two tertiary referral centers in Japan in patients endoscopically diagnosed with T1a SESCC on the post-ER scar. Focal CBAS was used for cryoablation, with specific criteria for lesion selection and treatment method. The primary endpoint was local complete response (L-CR) rate of the primary lesion 48 weeks after the first cryoablation as evaluated by an independent central evaluation committee. RESULTS: From October 2020 to October 2021, 15 patients with 17 lesions underwent cryoablation, with two requiring repeat cryoablation. The L-CR rate for primary and all lesions evaluated by the central evaluation committee was 100%. The endoscopist's evaluation was consistent with these results. The median procedure time was 9 min. Eight patients experienced no pain, and the highest pain score reported on a numeric 1-10 rating scale was 3. The technical success rate was 94.7% (18/19). Throughout the median follow-up period of 14.3 months, recurrences, deaths, or severe treatment-related adverse events were not reported. CONCLUSIONS: CBAS is a potentially safe and effective approach for SESCC on post-ER scars and represents an encouraging alternative to traditional endoscopic treatments.

Long-term outcomes after non-curative endoscopic resection for esophageal squamous cell carcinoma followed by additional chemoradiotherapy.

Endoscopic resection (ER) of esophageal squamous cell carcinoma (ESCC) is evaluated pathologically, and additional treatment is recommended for cases resulting in non-curative resection, defined as pMM with lymphovascular invasion (LVI), pSM, or positive vertical margin. This study aimed to assess long-term outcomes and risk factors for recurrence in patients with ESCC treated with non-curative ER followed by additional chemoradiotherapy (CRT). We retrospectively reviewed the clinical courses of patients who underwent non-curative ER followed by additional CRT for ESCCs between August 2007 and December 2017. Recurrence rates and risk factors for recurrence were analyzed. Among 97 patients with non-curative ER, 73 underwent additional CRT. With a median follow-up period of 71 months, recurrences were observed in 10 (14%) of 73 patients, with a median interval of 24.5 (1-59 months). The 3- and 5-year recurrence-free survival were 89 and 85%, respectively, and the 3- and 5-year overall survival rates were 96 and 91%, respectively. Multivariate analysis showed that lymphatic invasion was an independent risk factor for recurrence in patients with non-curative ESCC receiving additional CRT. Among the 10 patients with recurrence, 4, 3, 2, and 1 underwent surgery, chemotherapy, supportive care, and CRT, respectively. Notably, all four patients who underwent surgery survived, regardless of regional and/or distant lymph node metastasis. Lymphatic invasion is an independent risk factor for the recurrence of non-curative ESCCs. Careful follow-up is required for at least 5 years after ER with additional CRT.

Clinical and endoscopic features of metachronous gastric cancer with possible lymph node metastasis after endoscopic submucosal dissection and Helicobacter pylori eradication.

BACKGROUND: Several studies have reported the metachronous gastric cancers (MGCs) with possible lymph node metastasis (LNM) after endoscopic submucosal dissection (ESD) and Helicobacter pylori (H. pylori) eradication in which a curative ESD had not been achieved. There have been no published reports of evaluations of the features of patients with MGC with possible LNM after ESD and H. pylori eradication. METHODS: We identified 264 patients with 369 MGCs after H. pylori eradication among the 4354 patients with 5059 early gastric cancers (EGCs) who underwent ESD between 1999 and 2017 and divided them into two groups: patients with MGCs with possible LNM (Group I) and patients with MGCs undergone curative ESD (Group II). We retrospectively compared the features of patients with MGCs and patients with EGCs at index ESD in the two groups. RESULT: Group I consisted of 20 patients with 21 MGCs, and Group II consisted of 244 patients with 348 MGCs. Group I lesions were significantly more common in the posterior wall than in the lesser curvature (odds ratio [OR] = 3.97; 95% confidence intervals [CI] 1.20-13.10). Development of Group I was significantly more common in patients with a body mass index (BMI) < 19.0 kg/m2 than in patients with a BMI ≥ 19.0 kg/m2 at index ESD (OR = 4.44; 95% CI 1.30-15.20). CONCLUSIONS: During surveillance endoscopy after gastric ESD and H. pylori eradication, the posterior wall should be carefully examined to detect MGCs early. Lower BMI may be associated with the development of MGCs with possible LNM.

Comparison of treatment outcomes between endoscopic submucosal dissection with the needle-type knife and insulated-tip knife for superficial esophageal neoplasms.

Our study aimed to compare the treatment outcomes between endoscopic submucosal dissection (ESD) with an insulated-tip knife (ESD-IT) and a needle-type knife (ESD-N) for large superficial esophageal neoplasms, as no study of this kind has been previously reported. We used the dataset of a multicenter, randomized controlled trial that compared conventional ESD (C-ESD) and traction-assisted ESD (TA-ESD) for superficial esophageal neoplasms. We compared the procedural outcomes between ESD-IT and ESD-N in a post hoc analysis and conducted sub-analyses based on traction assistance and electrical knife type. We included 223 (EST-IT, n = 169; ESD-N, n = 54) patients with no significant differences in baseline characteristics. The operator handover rate due to ESD difficulties was significantly higher in ESD-N (ESD-IT = 0.6% vs. ESD-N = 13.0%, P = 0.001), while the injection volume was significantly higher in ESD-IT than in ESD-N (40.0 vs. 20.5 mL, P < 0.001). Other outcomes were comparable between both groups (procedural time: 51.0 vs. 49.5 minute, P = 0.89; complete resection: 90.5% vs. 90.7%, P > 0.99; and complication rate: 1.8% vs. 3.7%, P = 0.60 for ESD-IT and ESD-N, respectively). In the sub-analyses, the handover rate was significantly lower with TA-ESD than with C-ESD for ESD-N (3.2% vs. 26.1%, P = 0.034), and a significantly smaller injection volume was used in TA-ESD than in C-ESD for ESD-IT (31.5 vs. 47.0 mL, P < 0.01). ESD with either endoscopic device achieved favorable treatment outcomes with low complication rates. The handover rate in ESD-N and the injection volume in ESD-IT improved with the traction method.

Clinical course and management of adverse events after endoscopic resection of superficial duodenal epithelial tumors: Multicenter retrospective study.

OBJECTIVES: This study aimed to elucidate the clinical course and management of adverse events (AEs) after endoscopic resection (ER) for superficial duodenal epithelial tumors (SDETs). METHODS: Consecutive patients who underwent ER of SDETs between January 2008 and July 2018 at 18 Japanese institutions were retrospectively enrolled. The study outcomes included the clinical course, management, and risk of surgical conversion with perioperative AEs after ER for SDETs. RESULTS: Of the 226 patients with AEs, the surgical conversion rate was 8.0% (18/226), including 3.7% (4/108), 1.0% (1/99), and 50.0% (12/24) of patients with intraoperative perforation, delayed bleeding, or delayed perforation, respectively. In the multivariate logistic analysis, involvement of the major papilla (odds ratio [OR] 12.788; 95% confidence interval [CI] 2.098-77.961, P = 0.006) and delayed perforation (OR 37.054; 95% CI 10.219-134.366, P < 0.001) were significant risk factors for surgical conversion after AEs. Delayed bleeding occurred from postoperative days 1-14 or more, whereas delayed perforation occurred within 3 days in all cases. CONCLUSIONS: The surgical conversion rate was higher for delayed perforation than those for other AEs after ER of SDETs. Involvement of the major papilla and delayed perforation were significant risk factors for surgical conversion following AEs. In addition, reliable prevention of delayed perforation is required for 3 days after duodenal ER to prevent the need for surgical interventions.

Outcomes of endoscopic resection for superficial duodenal tumors: 10 years' experience in 18 Japanese high volume centers.

BACKGROUND: 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. METHODS: 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. RESULTS: 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 %; P < 0.001), but not for lesions > 20 mm (6.1 % vs. 7.1 %; P = 0.64). The local recurrence rate was significantly lower in the ESD group than in the non-ESD groups (P < 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 (P < 0.001). CONCLUSIONS: ER outcomes for SDETs were generally acceptable. ESD by highly experienced endoscopists might be an option for very large SDETs.

Emerging texture and color enhancement imaging in early gastric cancer.

Screening endoscopy improves detection and prognosis of patients with gastric cancer. However, even expert endoscopists can miss early gastric cancer under standard white light imaging. Texture and color enhancement imaging (TXI) is an image-enhanced endoscopy that enhances brightness, surface irregularities such elevation or depression, and subtle color changes. A few image-oriented studies have compared the gastric color differences between neoplastic and peripheral areas under both white light imaging and TXI. The results not only suggested that the overall color differences to be more pronounced in TXI, but also that TXI mode 1 was superior to white light imaging in the visibility of early gastric cancer. Despite the promising results in these initial studies, it is unclear whether the superiority of the image-enhanced endoscopy will translate into an improvement in early gastric cancer detection in real practice. Therefore, large-scale prospective studies are necessary to investigate the efficacy of this new technology in the evaluation of patients undergoing screening endoscopy.

Pivotal trial of a biodegradable stent for patients with refractory benign esophageal stricture.

OBJECTIVE: Benign esophageal strictures (BES) cause dysphagia and decrease patients' quality of life. Although mechanical dilation is the standard of care for BES, in some patients, dysphagia is unrelieved despite repeated procedures. The biodegradable stent was developed to resolve refractory BES, with reported favorable outcomes, but it is unapproved in Japan. Thus, we evaluated the safety and efficacy of the biodegradable stent (BDS) for patients with refractory BES for regulatory approval. METHODS: This was a nonrandomized single-arm prospective trial conducted at eight institutions. We included patients with BES after ≥ 5 times of dilation or ≥ one time of radial incision and cutting whose dysphagia score (DS) was 2 or worse and an endoscope could not admit. The primary endpoint was the proportion of patients whose DS improvement of ≤ 1 was maintained at 3 months. RESULTS: Thirty patients (median age: 69 years, male/female: 27:3) were enrolled and treated; BDS placement failed in 1 patient. Fourteen patients maintained their DS improvement until 3 months after placement (proportion of DS improvement at 3 months 46.7% [95% CI: 28.3-65.7]), and the median dysphagia-free survival was 98 days [95% CI: 68-123]. Most adverse events could be managed conservatively; however, a patient with BES after chemoradiotherapy (CRT) developed an esophago-left atrium fistula and died approximately 4 months after stent placement. CONCLUSION: The BDS was effective for refractory BES and the safety was acceptable. However, the indication for this procedure in patients RECEIVING CRT for esophageal cancer should be carefully considered.

Novel hybrid endoscopy-assisted larynx-preserving esophagectomy for cervical esophageal cancer (with video).

Hybrid endoscopy-assisted larynx-preserving esophagectomy is developed for cervical esophageal squamous cell carcinoma encroaching or extending above the upper esophageal sphincter. First, a cervical incision was surgically performed followed by cervical lymph node dissection. Second, the margin of cervical esophageal squamous cell carcinoma was endoscopically identified with iodine staining and marked endoscopically followed by semi-circumferential or circumferential endoscopic full-thickness excision around the lumen of the esophagus. The distal margin was surgically resected and reconstruction was performed. Among six consecutive patients with cervical esophageal squamous cell carcinoma undergoing hybrid endoscopy-assisted larynx-preserving esophagectomy, proximal surgical margin was histologically negative in five patients. During a median follow-up period of 15.5 months, all patients tolerated oral intake and were alive without evidence of recurrence. None of the patients experienced aspiration pneumonia, vocal disorder or postoperative anastomotic stricture. Hybrid endoscopy-assisted larynx-preserving esophagectomy could be a clinically feasible treatment for cervical esophageal squamous cell carcinoma providing accurate proximal resection margin with the benefit of laryngeal function preservation.

Endoscopic Closure Utilizing Endoloop and Endoclips After Gastric Endoscopic Submucosal Dissection for Patients on Antithrombotic Therapy.

OBJECTIVES: Antithrombotic therapy is a well-known independent risk factor for bleeding after endoscopic submucosal dissection (ESD) of early gastric cancer (EGC). A novel method of ulcer base closure using an endoloop and endoclips has been reported. This study aimed to evaluate the effectiveness of endoscopic closure using an endoloop and endoclips in preventing post-ESD bleeding in patients undergoing gastric ESD on antithrombotic therapy. METHODS: This was a single center, retrospective study. Patients on antithrombotic therapy who underwent gastric ESD were divided into two groups, the closure group and the non-closure group. We analyzed procedural outcomes, post-ESD bleeding rate and factors associated with post-ESD bleeding. RESULTS: Among 400 ESDs with EGCs in 311 patients, 131 ESDs in 110 patients were in the closure group, and 269 ESDs in 217 patients were in the non-closure group (16 patients were overlapped in both groups). Post-ESD bleeding rate was 11.5% (15/131) in the closure group, and 11.9% (32/269) in the non-closure group (p = 0.89). Total sustained closure rate during second look endoscopy was 47.8% (33/69). Post-ESD bleeding rate tended to be lower in the closure group than in the non-closure group for lesions located in the greater curvature (3.6% vs. 11.1%, p = 0.11). In addition, sustained closure rate was significantly higher in the greater curvature than in the lesser curvature (72.0% vs. 34.1%, p < 0.01). Multivariate analysis revealed resection size > 40 mm and heparin bridge were the independent risk factor for post-ESD bleeding. CONCLUSION: Ulcer base closure using endoloop and endoclips did not prevent post-ESD bleeding in patients on antithrombotic therapy.

Long-term outcomes of patients with recurrent squamous cell carcinoma of the esophagus undergoing salvage endoscopic resection after definitive chemoradiotherapy.

BACKGROUND: Salvage endoscopic resection (ER) has been reported to be effective for patients with local failure of esophageal squamous cell carcinoma (ESCC) after definitive chemoradiotherapy (dCRT). This study aimed to evaluate the long-term outcomes of salvage ER for patients with local failure of ESCC and to identify risk factors associated with disease recurrence after salvage ER. METHODS: This study included 45 patients undergoing salvage ER after dCRT during 2000 to 2017. After ER, all patients were required to undergo surveillance esophagogastroduodenoscopy (EGD) once or twice every year, and a computed tomography (CT) examination was repeated every 3 to 6 months. We assessed short-term outcomes and long-term outcomes. RESULTS: Of the 45 patients in this study, the baseline clinical T stage before dCRT was T1 in 80%, 66% of the patients did not have nodal metastasis. The median time from CRT to the detection of local failure was 11 months (range 2-130 months). The en-bloc resection rate was 46%, and the R0 resection rate was 38%, respectively. Stricture occurred after salvage ER for one case, while adverse events such as bleeding or perforation and ER-related death did not occur. After a median observation period of 57 months, recurrence free survival at 3 years was 58%, overall survival was 72%, and disease specific survival was 81%. In multivariate analysis, clinical N stage before CRT was the only independent risk factor of recurrence after salvage ER (p = 0.04). CONCLUSIONS: Salvage ER might be effective local treatment in patients with local failure after dCRT. For the patients with clinical N stage, frequent surveillance should be performed.

Optimal selection of endoscopic resection in patients with esophageal squamous cell carcinoma: endoscopic mucosal resection versus endoscopic submucosal dissection according to lesion size.

En bloc resection is essential for accurate pathological evaluation in patients with superficial esophageal squamous cell carcinoma (SESCC). This retrospective study aimed to clarify optimal treatment selection of endoscopic resection according to lesion size. A total of 760 patients underwent endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) between January 2011 and December 2015. Among them, this retrospective study included 196 solitary index SESCC lesions ≤20 mm, with the deepest invasion to the mucosa or superficial submucosa endoscopically. The lesions were classified according to size measured via endoscopy as follows; group A: lesions ≤10 mm, group B: lesions ≥11 mm but ≤15 mm, and group C: lesions ≥16 mm but ≤20 mm. The short- and long-term outcomes were investigated for EMR and ESD subgroups. In patients undergoing EMR and ESD, en bloc resection rates for group A and B were not different (98.8 vs. 100%, 93.3 vs. 100%, respectively). However, the en bloc resection rate was significantly lower in EMR than that in ESD for group C (64.3 vs. 100%, P < 0.001). Furthermore, the use of adjunctive ablative therapy rate was significantly higher in EMR than that in ESD in group C (35.7 vs. 0%, P < 0.001). The 5-year cumulative local recurrence rate of group C was significantly higher than that of group A + B after EMR (P < 0.01). EMR was an adequate treatment for SESCC lesions ≤15 mm. On the other hand, ESD could be necessary to achieve en bloc resection for lesions ≥16 mm to avoid local recurrence.

A new reliable acoustic respiratory monitoring technology during upper gastrointestinal tract therapeutic endoscopy with CO2 insufflation.

Previous studies documented the effectiveness and benefits of capnography monitoring during propofol-based sedation for colonoscopy to reduce the incidence of hypoxemia. However, the performance of capnography during longer duration endoscopic therapy of upper gastrointestinal tract cancers under CO2 insufflation it is not well known. In this study, we compare a new device with acoustic monitoring technology to standard capnography monitoring. We retrospectively analyzed 49 patients who underwent endoscopic resection of early upper gastrointestinal tract cancer between December 2013 and October 2014. All 49 patients were monitored using both acoustic monitoring technology and standard capnography. We investigated the duration of the periods with unmeasurable respiratory rate during the overall procedure. When comparing standard capnography monitoring to the new acoustic monitoring technology, the ratio of the unmeasurable time was significantly lower in RRa (36.9% vs. 21.6%, p < 0.01). The ratio of unmeasurable respiratory rate by capnography was strongly correlated to the ratio of unmeasurable PETCO2 level by capnography (R2 = 0.847). There were no severe events or adverse events (grade 2 or more) during all 49 procedures. The acoustic monitoring technology provides a more reliable respiratory monitoring when compared to standard capnography during endoscopic resection of upper gastrointestinal tract cancers under CO2 insufflation, even if the procedures were prolonged and complex.

Safety and usefulness of endoscopic submucosal dissection for early esophageal cancers in elderly patients aged 80 years or older.

BACKGROUND AND AIM: Endoscopic submucosal dissection (ESD) for early gastrointestinal (GI) cancers is widely performed as a standard treatment in Japan. Given the increasing life expectancy worldwide, it is naturally regarded that the rate of elderly patients diagnosed with early GI cancer has increased. Available guidelines do not specifically outline how to manage endoscopic therapy for the elderly. The aim of this study was to assess the safety and usefulness of ESD for superficial esophageal squamous cell carcinoma (SESCC) in elderly patients. METHODS: We retrospectively investigated 393 consecutive patients, who underwent 426 ESD for 444 SESCCs from January 2011 to August 2016 at our institution. For this study, patients were divided into 2 groups based on their age; ≥ 80 years (Group aged ≥ 80 years, n = 42) and < 80 years (group aged < 80 years, n = 351). Patient demographics, sedation methods, technical outcomes, adverse events, sedatives, dosages given, overall survival, and disease-specific survival were then examined. RESULTS: The ESD procedure time was significantly longer for group aged ≥ 80 years than for group aged < 80 years (110 min [range 29-260] vs 85 min [24-504], p = 0.006); however, there was no significant differences between other technical items and adverse events. The 3-year overall survival and disease-specific survival were favorable in both groups. CONCLUSIONS: Esophageal ESD for elderly patients aged ≥ 80 years can be safely performed. Mid-term outcome was favorable. Our study suggests that esophageal ESD might be a useful treatment for SESCCs.

Conventional versus traction-assisted endoscopic submucosal dissection for large esophageal cancers: a multicenter, randomized controlled trial (with video).

BACKGROUND AND AIMS: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.).

Sporadic pyloric gland adenoma associated with a large fundic gland polyp: genetic evidence for stepwise progression.

Pyloric gland adenoma (PGA) is an uncommon variant of gastric adenoma exhibiting pyloric gland/mucous neck cell differentiation. We present a sporadic PGA associated with a large fundic gland polyp (FGP) in a woman in her 40 s without Helicobacter pylori infection. The polyp, measuring 25 mm in size, was located in the middle gastric body and was removed by endoscopic submucosal dissection. Histological examination revealed three morphologically distinct components: FGP, FGP with large cysts, and PGA. A genetic analysis identified a truncating APC mutation in all the three components, supporting their histogenetic relationship. Additionally, a GNAS mutation was detected in two components, FGP with large cysts and PGA, whereas a KRAS mutation was exclusively found in the PGA component. Thus, despite the unusual presentation, the PGA component harbored prototypical genetic alterations. The differential genetic alterations observed in the three components imply that they represent stepwise progression from FGP to PGA.

Risk of Lymph Node Metastasis in Patients with the Superficial Spreading Type of Esophageal Squamous Cell Carcinoma.

BACKGROUND: Little is known about the clinicopathological characteristics of superficial spreading-type esophageal carcinoma extending ≥5 cm along the long axis of the esophagus. This study was aimed at investigating the frequency of lymph node metastasis (LNM) in patients with superficial spreading-type esophageal carcinoma. METHODS: We reviewed the data of 320 patients with superficial esophageal squamous cell carcinoma who had undergone esophagectomy with lymph node dissection at our hospital between 1986 and 2010. The incidence of LNM was compared between the spreading (≥5 cm) and nonspreading (< 5 cm) types. RESULTS: The multivariate analysis revealed significant differences in the likelihood of LNM depending on the lymphovascular invasion, the infiltrative growth pattern (INF)-c, and the depth. There was no difference in the LNM frequency between nonspreading and spreading type in the patients with epithelium (EP)-lamina propria, muscularis mucosa (MM)-submucosa (SM)1 and SM2/3 lesions. The frequencies of LNMs (nonspreading-type vs. spreading-type tumors) in the patients with MM-SM1 lesions were 7/47 (14.9%) versus 4/25 (16%) and those in the patients with SM2/3 lesions were 22/58 (37.9%) versus 4/14 (28.9%), when the lesions did not have lymphovascular invasion and INF-c. CONCLUSIONS: Endoscopic resection can be selected for -EP-SM1 lesions, regardless of whether the lesions are of the spreading type or nonspreading type.

Conventional versus traction-assisted endoscopic submucosal dissection for gastric neoplasms: a multicenter, randomized controlled trial (with video).

BACKGROUND AND AIMS: The aim of this study was to clarify whether dental floss clip (DFC) traction improves the technical outcomes of endoscopic submucosal dissection (ESD). METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Clinical outcomes and prognostic factors in gastric cancer patients aged ≥85 years undergoing endoscopic submucosal dissection.

BACKGROUND AND AIMS: Although the number of gastric cancer patients aged ≥85 years indicated for endoscopic submucosal dissection (ESD) has increased, little is known about the outcomes and prognostic factors. This study aimed to investigate the clinical outcomes and prognostic factors for overall survival (OS) of patients aged ≥85 years who underwent ESD for gastric cancer. METHODS: We retrospectively reviewed 108 patients aged ≥85 years with 149 gastric cancers treated by ESD between 1999 and 2014 at our institution. The clinical outcomes and prognosis were evaluated. Furthermore, the relationships between patient and lesion characteristics with OS were determined using the Kaplan-Meier method and a Cox proportional hazards model. RESULTS: All patients had Eastern Cooperative Oncology Group performance status (PS) of 0 to 1. En bloc, R0, and curative resections were achieved in 98.0%, 91.3%, and 72.7%, respectively, without severe adverse events requiring surgery. During a median follow-up period of 40.2 months (range, 1.8-108.7 months), 23 patients died, including 2 of gastric cancer. The 3-year (54.3% vs 95.9%) and 5-year (54.3% vs 76.3%) OS rates were significantly lower in patients with a low (<44.6) as opposed to a higher (≥44.6) prognostic nutritional index (PNI) (P < .001). The PNI was independently prognostic of OS (hazard ratio, 7.0; 95% confidence interval, 2.2-22.9; P = .001). CONCLUSIONS: ESD is feasible for gastric cancer patients aged ≥85 years with good PS. However, low PNI was found to be prognostic of reduced OS, indicating the need to evaluate the PNI in determining whether to perform ESD.