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.

Risk of stricture after endoscopic submucosal dissection in the cervical esophagus and efficacy of local steroid injection for stricture prevention (with video).

BACKGROUND AND AIMS: There is a high incidence of stricture after endoscopic submucosal dissection (ESD) for cervical esophageal cancer. We aimed to elucidate the risk factors for stricture and to evaluate the efficacy of steroid injection for stricture prevention in the cervical esophagus. METHODS: We retrospectively analyzed 100 patients who underwent ESD for cervical esophageal cancer to (1) identify the factors associated with stricture among patients who did not receive steroid injection, and (2) compare the incidence of stricture between patients with and without steroid injection. RESULTS: Among 48 patients who did not receive steroid injection, there were significant differences in tumor size (P = .026), resection time (P = .028), and circumferential extent of the mucosal defect (P = .005) between patients with stricture (n = 5) and without stricture (n = 43). Compared with patients without steroid injection, patients with steroid injection had a significantly lower incidence of stricture when the post-ESD mucosal defect was <3/4 and ≥1/2 (40% versus 8%; P = .039). For the patients with a post-ESD mucosal defect of ≥3/4 (n = 13), local steroid injection was performed for all of them, and 6 (46%) developed stricture. CONCLUSIONS: Patients who underwent ≥1/2 circumferential resection were at high risk of cervical esophageal stricture. Steroid injection had a stricture prevention effect in patients with <3/4 and ≥1/2 circumferential resection, but seemed to be insufficient in preventing stricture in patients with ≥3/4 circumferential resection.

Endoscopic submucosal dissection for lesions developing in the irradiated area of head and neck cancer.

BACKGROUND AND AIM: Effective treatment of lesions that develop in the irradiated area of head and neck squamous cell carcinoma is a major concern. This study aimed to clarify the efficacy and safety of endoscopic resection for such lesions. METHODS: Among consecutive patients who underwent endoscopic resection for histologically proven head and neck squamous cell carcinoma between January 2014 and December 2021, those who received definitive radiotherapy/chemoradiotherapy before endoscopic resection were included in this single-center, retrospective study. Short- and long-term outcomes were evaluated. RESULTS: Among 422 patients who underwent endoscopic resection for 615 lesions, 43 patients with 57 lesions were eligible. All 57 lesions were treated with endoscopic submucosal dissection and en bloc resection was achieved in all lesions. Grade 3 of Common Toxicity Criteria for Adverse Events v5.0 occurred in eight (19%) patients (dysphagia, seven; stricture, three; aspiration pneumonia, two; and pharyngeal necrosis, one [some cases overlapped]), but no grade ≥ 4 events occurred. Enteral nutrition by gastrostomy was temporarily required in two patients owing to dysphagia and laryngeal necrosis. During the median follow-up of 40 (interquartile range, 29.5-61) months after endoscopic submucosal dissection for the lesions developed in the irradiated area, local recurrence and metachronous lesions developed in two (5%) and nine (21%) patients, respectively. However, total laryngectomies and tracheostomies were avoided in all patients. The 3-year overall and disease-specific survivals were 81% (95% confidence interval, 64%-91%) and 94% (95% confidence interval, 79%-99%), respectively. CONCLUSIONS: Favorable local control and safety of endoscopic submucosal dissection were demonstrated.

Predictors of technical difficulty for trainees in esophageal endoscopic submucosal dissection.

BACKGROUND: Esophageal endoscopic submucosal dissection (ESD) is technically challenging, especially for trainees, and requires a safe training system. This study aimed to identify predictors of technical difficulty facing trainees performing esophageal ESD to establish such system. METHODS: This was a single-center retrospective study of patients with esophageal cancer who underwent ESD performed by trainees between January 2010 and August 2022. Technical difficulties were defined as muscularis propria exposure and long procedure time (≥ 90 min). Factors associated with these technical difficulties were investigated. RESULTS: A total of 798 lesions in 721 patients were evaluated. Muscularis propria exposure occurred in 298 lesions (37.3%), including 10 perforations (1.3%). The procedure time was ≥ 90 min in 134 lesions (16.8%). In the multivariate analysis, tumor size ≥ 20 mm, tumors ≥ 1/2 of the circumference, and those close to previous treatment scars significantly increased the incidence of both difficulties, whereas tumors in the upper esophagus significantly decreased this incidence. Furthermore, female sex and tumors in the left wall were independent predictors of muscularis propria exposure, and elevated morphology was an independent predictor of long procedure time. Muscularis propria exposure and long procedure time occurred in more than half of the cases with three or more predictors of each difficulty. CONCLUSIONS: Large tumors and tumors close to previous treatment scars increase technical difficulties for trainees in esophageal ESD. Conversely, tumors in the upper esophagus reduce these difficulties. These results enable us to predict the difficulty level preoperatively and select appropriate cases in stepwise training.

Predictors of stricture after non-circumferential endoscopic submucosal dissection of the esophagus and single-dose triamcinolone injection immediately after the procedure.

BACKGROUND AND AIMS: Local triamcinolone (TA) injection is widely used to prevent stricture formation after endoscopic submucosal dissection (ESD). However, stricture develops in up to 45% of patients despite this prophylactic measure. We therefore conducted a single-center prospective study to identify predictors of stricture after esophageal ESD and local TA injection. METHODS: Patients who underwent esophageal ESD and local TA injection and who were comprehensively assessed for lesion- and ESD-related factors were included in the study. Multivariate analyses were conducted to identify the predictors of stricture. RESULTS: A total of 203 patients were included in the analysis. Multivariate analysis identified residual mucosal width ≤5 mm (odds ratio [OR], 29.0; P < .0001) or 6 to 10 mm (OR, 3.7; P = .04), history of chemoradiotherapy (OR, 5.1; P = .045), and tumor in the cervical or upper thoracic esophagus (OR, 3.8; P = .018) as independent predictors of stricture. Based on the ORs of the predictors, patients were stratified into 2 groups according to stricture risk: patients in the high-risk group (residual mucosal width ≤5 mm or 6-10 mm with another predictor) had a stricture rate of 52.5% (31 of 59 cases), and patients in the low-risk group (residual mucosal width ≥11 mm or 6-10 mm without other predictors) had a stricture rate of 6.3% (9 of 144 cases). CONCLUSIONS: We identified predictors of stricture after ESD and local TA injection. Local TA injection prevented stricture formation after ESD in low-risk patients but was not sufficient to prevent stricture in high-risk patients. Additional interventions should thus be considered in high-risk patients. (University Hospital Medical Network Clinical Trials Registry number: UMIN 000028894.).

Efficacy and safety of intensive downstaging polypectomy (IDP) for multiple duodenal adenomas in patients with familial adenomatous polyposis: a prospective cohort study.

BACKGROUND: Patients with familial adenomatous polyposis (FAP) risk developing multiple duodenal adenomas (MDAs), leading to duodenal cancer and death. We investigated the efficacy and safety of intensive downstaging polypectomy (IDP) for MDAs integrated with new-generation procedures. METHODS: This prospective phase II study, conducted at a tertiary cancer center, enrolled patients with FAP who had MDAs. We performed IDP including cold snare/forceps polypectomy (CSP/CFP) and underwater endoscopic mucosal resection (UEMR). The primary end point was the downstaging of Spigelman stage at 1-year follow-up. RESULTS: 2424 duodenal polyps in 58 patients with FAP underwent IDP, including 2413 CSPs in 57 patients, seven CFPs in one patient, and four UEMRs in four patients. Only one major adverse event was observed (grade 3 hyperamylasemia) without clinical manifestations. We performed additional UEMR, CSP, and CFP for one, 12, and 22 patients, respectively, during initial follow-up. Overall, 55 patients completed protocol examination; the Spigelman stage was significantly reduced at the 1-year follow-up endoscopy (P < 0.001), with downstaging observed in 39 patients (71 %). Among the 26 patients with Spigelman stage IV at initial examination and protocol completion, 23 (88 %) showed downstaging. There was no major change in Spigelman stages from 1-year follow-up esophagogastroduodenoscopy to a median of 37 months (range 3-56). CONCLUSIONS: IDP, including new-generation procedures, showed significant downstaging with acceptable adverse events for MDA in patients with FAP, even those with advanced-stage disease. Lesion selection for different resection techniques may be important for suitable and sustainable management of MDA in patients with FAP.

A single-center prospective study evaluating the usefulness of artificial intelligence for the diagnosis of esophageal squamous cell carcinoma in a real-time setting.

BACKGROUND: Several pre-clinical studies have reported the usefulness of artificial intelligence (AI) systems in the diagnosis of esophageal squamous cell carcinoma (ESCC). We conducted this study to evaluate the usefulness of an AI system for real-time diagnosis of ESCC in a clinical setting. METHODS: This study followed a single-center prospective single-arm non-inferiority design. Patients at high risk for ESCC were recruited and real-time diagnosis by the AI system was compared with that of endoscopists for lesions suspected to be ESCC. The primary outcomes were the diagnostic accuracy of the AI system and endoscopists. The secondary outcomes were sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and adverse events. RESULTS: A total of 237 lesions were evaluated. The accuracy, sensitivity, and specificity of the AI system were 80.6%, 68.2%, and 83.4%, respectively. The accuracy, sensitivity, and specificity of endoscopists were 85.7%, 61.4%, and 91.2%, respectively. The difference between the accuracy of the AI system and that of the endoscopists was - 5.1%, and the lower limit of the 90% confidence interval was less than the non-inferiority margin. CONCLUSIONS: The non-inferiority of the AI system in comparison with endoscopists in the real-time diagnosis of ESCC in a clinical setting was not proven. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCTs052200015, 18/05/2020).

Indication of emergency colonoscopy after colorectal endoscopic submucosal dissection: A proposal of hematochezia scale.

BACKGROUND AND AIM: Hematochezia is a major adverse event associated with colorectal endoscopic submucosal dissection (ESD). This study aimed to distinguish between hematochezia that required endoscopic hemostasis and hematochezia that required no hemostasis. METHODS: This retrospective study included consecutive patients who underwent ESD for colorectal tumors at the Osaka International Cancer Institute between September 2017 and August 2020. The exclusion criteria were as follows: patients with coexisting advanced colorectal cancers or inflammatory bowel diseases, patients who received incomplete ESD or emergency surgery, or patients who underwent ESD for multiple lesions. We evaluated whether the patients had hematochezia and underwent emergency colonoscopy and hemostasis during hospitalization. The degree of hematochezia in the saved photographs was assessed using the hematochezia scale and classified as mild, moderate, or severe. Blood pressure, heart rate, time from ESD to first hematochezia, and total number of hematochezia episodes were also evaluated. RESULTS: Among the 437 patients who underwent ESD, 44 were excluded, and 393 patients were evaluated. Hematochezia was observed in 100 patients (25%). Emergency colonoscopy was performed in 12 patients (3%), and hemostasis was required in six patients (2%). For patients with hematochezia, only mild hematochezia and hematochezia that developed ≤ 48 h after ESD were significantly associated with no intervention for hemostasis. The positive predictive value for no intervention for hemostasis was 100% (93-100%) for mild hematochezia and 98% (93-100%) for hematochezia ≤ 48 h. CONCLUSIONS: Mild hematochezia and hematochezia ≤ 48 h were negative predictors of hemostasis, in which emergency colonoscopy may be avoided.

Impact of endoscopic surveillance on mortality of metachronous esophageal and head and neck cancer after esophageal endoscopic resection.

BACKGROUND AND AIM: As more superficial esophageal cancer (EC) patients are being treated with endoscopic resection (ER), it is important to understand the outcomes, including survival data, of patients who develop metachronous EC and head and neck cancer (HNC). We aimed to evaluate the long-term surveillance and survival outcomes of metachronous EC and HNC after esophageal ER. METHODS: This study included 627 patients who underwent ER of superficial esophageal squamous cell carcinoma from 2008 to 2016 and were generally followed by annual or biannual esophagogastroduodenoscopy up to 2019 at Osaka International Cancer Institute. Data on metachronous cancer development and causes of death were collected from an integrated database of hospital-based cancer registry and Vital Statistics of Japan. RESULTS: During a median (range) follow-up period of 67.4 (3.8-142.7) months, 230 patients (36.7%) developed 500 metachronous ECs and 126 patients (20.1%) developed 239 metachronous HNCs, post-ER of index EC. The 3-year, 5-year, and 7-year cumulative incidences were 25.8%, 36.0%, and 43.6% for metachronous EC and 10.9%, 16.0%, and 26.9% for metachronous HNC, respectively. No patients died of metachronous EC, and only seven patients (1.1%) died of metachronous HNC. The 3-year, 5-year, and 7-year disease-specific survival rates were 99.8%, 99.6%, and 98.6%, respectively. CONCLUSIONS: The incidences of metachronous EC and HNC increase with time over 5 years after esophageal ER; therefore, surveillance endoscopy should be continued over 5 years. Endoscopic surveillance is useful for survivors after esophageal ER given the high incidence and extremely low mortality of metachronous EC and HNC.

Safety and efficacy of cold versus hot snare polypectomy including colorectal polyps ≥1 cm in size.

Cold snare polypectomy (CSP; polypectomy without electrocautery) has spread rapidly worldwide during the past decade in what has been called "Cold Revolution". We performed a PubMed literature search for studies investigating CSP outcomes for colorectal polyps. Five randomized controlled trials (RCTs) assessed the complete resection rates (CRRs). The CRRs were similar regardless of the presence or absence of electrocautery, and the efficacy of submucosal injection for better CRRs is still controversial. Eight RCTs assessed the adverse events. The incidence of intraprocedural bleeding with cold procedures was comparable to or higher than that of hot procedures. The incidences of delayed bleeding were comparable to or lower with cold procedures, especially in patients taking anticoagulants. Fifteen studies have been reported on CSP for large (≥1 cm) colorectal polyps (10 retrospective studies, four prospective single-arm studies, and one prospective RCT). These studies reported that the safe cold procedures (a low intra- and post-procedural bleeding rate without perforation) could be implemented for lesions ≥1 cm. However, considering the incision depth of CSP and the local recurrence rate based on the current evidence, only large sessile serrated lesions (SSLs) can be candidates for cold procedures, and large adenomas should not be candidates for this procedure. Based on the current evidence, CSP seems to be the appropriate standard procedure for sub-centimeter colorectal low-grade adenomas due to its safety and simplicity. Thus, large SSLs can be candidates for cold procedures; however, careful inspection and further prospective studies are warranted to confirm the procedure's clinical relevance.

Positive predictive value of the clinical diagnosis of T1a-epithelial/lamina propria esophageal cancer depends on lesion size.

OBJECTIVES: Endoscopic resection (ER) is a minimally invasive treatment for esophageal squamous cell carcinoma (ESCC). However, stricture may develop after ER for widespread lesions. Application of ER is justified if these cancers are pathological T1a-epithelial/lamina propria (pEP/LPM) cancers that can be cured by ER. We conducted a study to clarify the association between pathological invasion depth and lesion size or circumference in clinical (c) EP/LPM cancers. METHODS: From our database, we identified patients diagnosed with cEP/LPM ESCC via endoscopic examination who underwent endoscopic or surgical tumor resection. The accuracy of the cEP/LPM ESCC diagnosis was determined by histologically diagnosing cancer invasion depth as a reference standard. RESULTS: Between January 2015 and December 2019, 1271 cancer patients were diagnosed with cEP/LPM ESCC, of which 1195 (94.0%) were correctly diagnosed with pEP/LPM cancer. The positive predictive value (PPV) classified according to lesion sizes of ≤25, 26-49, and ≥50 mm was 95.8% (981/1024 lesions), 89.7% (191/213 lesions), and 67.6% (23/34 lesions), respectively. PPV according to the circumferential extent of <3/4, ≥3/4, and <1, and whole was 94.6% (1164/1230 lesions), 75.0% (24/32 lesions), and 77.8% (7/9 lesions), respectively. In multivariate analysis, the PPV of cEP/LPM ESCC was significantly associated with lesion size (P < 0.001) and male sex. CONCLUSIONS: Between January 2015 and December 2019, 1271 cancer patients were diagnosed with cEP/LPM ESCC, of which 1195 (94.0%) were correctly diagnosed with pEP/LPM cancer. The PPV of cEP/LPM ESCC was related to lesion size. Treatment should be determined considering the high risk of cancer invasion into the muscularis mucosa or deeper in cEP/LPM cancers with a lesion size of ≥50 mm.

Partial trapeziectomy for Eaton stage III thumb carpometacarpal arthritis: ligament reconstruction with tendon interposition using the entire flexor carpi radialis and interference screw fixation.

BACKGROUND: Trapeziectomy with ligament reconstruction and tendon interposition (LRTI) is currently the most popular technique for treating primary osteoarthritis of the thumb carpometacarpal joint. However, reduced trapezial height has sometimes been reported after LRTI. Longer immobilization and delayed rehabilitation times are also problematic. In this study, we evaluated the clinical and radiological outcomes of patients who underwent our modified LRTI procedure. METHODS: Retrospective study included 26 thumbs in 24 cases with advanced stages. Our modified Burton's procedure was as follows: (1) trapeziectomy was limited to distal-half, (2) the entire flexor carpi radialis (FCR) was harvested from the forearm, and (3) half-slip of the FCR tendon was stabilized by interference screw in the first metacarpal bone tunnel. RESULTS: Pain on the visual analogue scale (VAS), the quick Disabilities of the Arm Shoulder and Hand score, tip pinch strength significantly improved postoperatively. The preoperative height of the trapezial space was well-maintained at final follow-up. Magnetic resonance imaging at the one-year follow-up showed the existence of FCR tendon ball in 15 cases. Eighteen housewives resumed their daily activities after a mean period of 10 days postoperative, while another 6 patients returned to their original jobs after 3 weeks. CONCLUSIONS: Our modified LRTI method involves distal-half trapeziectomy and entire FCR interposition. A sewn FCR tendon ball always provide enough volume to fill the trapeziectomy space, which helps to prevent sinking of the metacarpal bone. Our technique produced sufficient ligamentoplasty and allowed early mobilization after surgery.

Prevalence of Genu Recurvatum during Walking and Associated Knee Pain in Chronic Hemiplegic Stroke Patients: A Preliminary Survey.

BACKGROUND: Although genu recurvatum during walking is a well-known issue in stroke rehabilitation, there are no reliable epidemiological data on its prevalence. The aim of the study was to investigate the prevalence of genu recurvatum during walking and associated knee pain among ambulatory community-dwelling patients with chronic hemiplegic stroke. METHODS: Questionnaires were sent to physical therapists working at 223 adult day care facilities in Chiba Prefecture, Japan. The number of all chronic stroke patients attending the day care who could walk without human assistance, including those who used a walking aid and/or an orthosis; the number of patients with genu recurvatum in the paretic limb during walking; and the number of patients with genu recurvatum who had experienced any knee pain in the last month were investigated. Physical therapists were also asked whether they considered genu recurvatum in stroke patients to be problematic. RESULTS: Sixty-four facilities (28.7%) responded, providing data on 1110 ambulatory stroke patients, of whom 217 (19.5%) showed genu recurvatum. Of the patients with genu recurvatum, 25 (11.5%) experienced knee pain in the paretic limb. Of 45 physical therapists who gave an opinion on whether genu recurvatum was problematic, 26 (57.8%) thought it was problematic whereas 19 thought it was not problematic. CONCLUSION: Rates of genu recurvatum and associated knee pain were relatively low among ambulatory community-dwelling stroke survivors attending adult day care.

Use of Mini TightRope® for Delayed Presentation of a Fifth Carpometacarpal Joint Dislocation.

Introduction: Isolated dislocations of the fifth carpometacarpal joint (CMCJ) are uncommon injuries of the hand that is often missed but can be diagnosed correctly with a high index of suspicion and adequate imaging. Treatment for chronic cases is usually open reduction with temporary fixation using Kirschner wires, but for this case, we used Mini TightRope® as well to allow for early finger exercise. The case presented here is unique because of a delayed dislocation of a CMCJ detected 9 weeks from initial injury which was treated with a novel form of fixation with Mini TightRope®. Case Report: A 70-year-old, right-hand dominant, male farmer injured his left hand when he slipped and fell on a concrete surface, landing on the ulnar side of his left hand. He was immediately seen in the clinic, just with a swollen left hand but no obvious deformity and with apparently normal PA and oblique radiographs of the hand. Nine weeks later, he came back due to persistent ulnar-sided hand pain; repeat radiographs and a CT scan of the left hand showed ulno-palmar dislocation of the fifth CMCJ. He then underwent trial closed reduction of the 5th CMCJ dislocation but failed. Open reduction, temporary K-wire fixation, and fixation using Mini TightRope® through the 4th and 5th metacarpals were done. A full range of motion of the hand was allowed immediately post-operative. Reduction was maintained and no complications were noted on subsequent follow-up visits. Conclusion: This paper presents a brief literature review on 5th CMCJ dislocation, discussing the anatomic considerations contributing to joint stability, helpful radiographic parameters for diagnosis, and enumeration of treatment options.