Sample Collection Methods in Upper Gastrointestinal Research.

In recent years, significant translational research advances have been made in the upper gastrointestinal (GI) research field. Endoscopic evaluation is a reasonable option for acquiring upper GI tissue for research purposes because it has minimal risk and can be applied to unresectable gastric cancer. The optimal number of biopsy samples and sample storage is crucial and might influence results. Furthermore, the methods for sample acquisition can be applied differently according to the research purpose; however, there have been few reports on methods for sample collection from endoscopic biopsies. In this review, we suggested a protocol for collecting study samples for upper GI research, including microbiome, DNA, RNA, protein, single-cell RNA sequencing, and organoid culture, through a comprehensive literature review. For microbiome analysis, one or two pieces of biopsied material obtained using standard endoscopic forceps may be sufficient. Additionally, 5 mL of gastric fluid and 3-4 mL of saliva is recommended for microbiome analyses. At least one gastric biopsy tissue is necessary for most DNA or RNA analyses, while proteomics analysis may require at least 2-3 biopsy tissues. Single cell-RNA sequencing requires at least 3-5 tissues and additional 1-2 tissues, if possible. For successful organoid culture, multiple sampling is necessary to improve the quality of specimens.

Endoscopic vacuum therapy for the management of upper GI leaks and perforations: a multicenter retrospective study of factors associated with treatment failure (with video).

BACKGROUND AND AIMS: The optimal management of upper GI (UGI) leaks and perforations remains controversial. Endoscopic vacuum therapy (EVT) is a new alternative endoscopic treatment that has recently shown a high rate of successful closure of UGI leaks and perforations. However, only few reports have been made on the factors that affect clinical success rates. METHODS: Four referral hospitals participated in this retrospective multicenter study. Between September 2015 and February 2020, 119 patients who underwent EVT for a UGI perforation or leak were included. We retrospectively evaluated the clinical outcomes of EVT and the factors associated with EVT failure. Neoadjuvant treatments included chemotherapy, radiotherapy, or chemoradiotherapy before surgery, and the intraluminal method meant that the sponge was placed directly onto the defect within the lumen of UGI tract. RESULTS: Among 119 patients, 84 showed clinical success (70.6%). Eighty-nine patients (74.8%) underwent EVT as primary therapy and 30 patients as rescue therapy. On multivariate analysis, neoadjuvant treatment and the intraluminal method were significant independent risk factors for EVT failure. During the follow-up period (median, 8.46 months), stenosis occurred in 22 patients (18.5%). The overall survival rate of the EVT success group was significantly higher than that of the EVT failure group. Twenty-two patients died because of non-EVT-related causes, and 7 patients died because of leakage-related adverse events. No death was caused by the EVT itself. CONCLUSIONS: EVT is a promising treatment method for UGI leaks and perforations. Further studies are needed to establish the indications for successful EVT.

Combination of Enhanced Instructions Improve Quality of Bowel Preparation: A Prospective, Colonoscopist-Blinded, Randomized, Controlled Study.

BACKGROUND: Appropriate bowel preparation is highly important for the efficacy of colonoscopy; however, up to one-third of patients do not accomplish adequate bowel preparation. OBJECTIVE: We investigated the impact of the combination of enhanced instruction on the quality of bowel preparation and its impact on clinically relevant outcomes. DESIGN: This was a colonoscopist-blinded, prospective, randomized trial. SETTINGS: All patients received regular instructions for bowel preparation. Patients were randomly assigned to the control, telephone reeducation, and combined enhanced instruction groups. PATIENTS: Outpatients aged 19 to 75 years scheduled to undergo colonoscopy were included. MAIN OUTCOME MEASURES: The main outcome was adequate bowel preparation rate. RESULTS: A total of 311 patients were randomly assigned to the combined enhanced instruction (n = 104), telephone reeducation (n = 101), and control groups (n = 106). An intention-to-treat analysis showed that the adequate bowel preparation rate was higher in the combined enhanced instruction group than in the telephone reeducation and control groups (92.3% vs 82.2% vs 76.4%, p = 0.007). The rate of compliance with the instructions was significantly higher in the combined enhanced instruction group than in the telephone reeducation and control groups. Method of education was associated with proper bowel preparation (adjusted OR 17.46; p < 0.001 for combined enhanced instruction relative to control). LIMITATIONS: This was a single-center study conducted in Korea. CONCLUSIONS: Combined enhanced instruction as an adjunct to regular instructions much improved the quality of bowel preparation and patients' adherence to the preparation instructions. The combined enhanced instruction method could be the best option for bowel preparation instruction. See Video Abstract at http://links.lww.com/DCR/B673. LA COMBINACIN DE INSTRUCCIONES MEJORADAS, INCREMENTA LA CALIDAD DE LA PREPARACIN INTESTINAL ESTUDIO PROSPECTIVO, CONTROLADO, ALEATORIO Y CIEGO PARA EL COLONOSCOPISTA: ANTECEDENTES:La preparación adecuada del intestino es muy importante para la eficacia de la colonoscopia; sin embargo, hasta un tercio de los pacientes no logran buenos resutlados.OBJETIVO:Investigar el impacto de la combinación de instrucciónes claras en la calidad de la preparación intestinal y su impacto en los resultados clínicos.DISEÑO:Trabajo aleatorio, prospectivo y ciego para el colonoscopista.AJUSTES:Los pacientes recibieron instrucciones periódicas para la preparación intestinal. Fueron asignados aleatoriamente al grupo control, educación telefónica y de instrucción mejoradas.PACIENTES:Se incluyeron pacientes ambulatorios de 19 a 75 años programados para ser sometidos a colonoscopia.PRINCIPALES MEDIDAS DE RESULTADO:El principal resultado fue una adecuada preparación intestinal.RESULTADOS:Un total de 311 pacientes fueron asignados al azar a la instrucción mejorada combinada (n = 104), reeducación telefónica (n = 101) y grupo de control (n = 106). El análisis estadístico mostró que la tasa de preparación intestinal adecuada fue mayor en el grupo combinado de instrucción mejorada que en los grupos de reeducación telefónica y control (92,3% vs 82,2% vs 76,4%, p = 0,007). La tasa de cumplimiento de las instrucciones fue significativamente mayor en el grupo de instrucción mejorada combinada que en los otros. El método de educación se asoció con una preparación intestinal adecuada (razón de posibilidades ajustada de 17,46; p <0,001 para la instrucción mejorada combinada en relación con el control.LIMITACIONES:Estudio en un solo centro realizado en Corea.CONCLUSIONES:La instrucción mejorada combinada como complemento de las instrucciones regulares mejoró mucho la calidad de la preparación intestinal y la adherencia de los pacientes a las instrucciones de preparación. El método de instrucción mejorado combinado podría ser la mejor opción para la instrucción de preparación intestinal. Consulte Video Resumen en http://links.lww.com/DCR/B673.

Propofol compared with bolus and titrated midazolam for sedation in outpatient colonoscopy: a prospective randomized double-blind study.

BACKGROUND AND AIMS: The safest and most efficient method of sedation for outpatient colonoscopy remains unclear. This study aimed to compare the efficiency and safety of bolus administration of midazolam compared with titrated administration and propofol administration for patients undergoing outpatient colonoscopy. METHODS: We randomly divided patients undergoing colonoscopy into the propofol group, bolus midazolam group, and titrated midazolam group. We compared total procedure time, induction time, recovery time, and discharge time among the 3 groups. We also compared patient satisfaction and the incidence of adverse events. RESULTS: In total, 267 patients (89 in each study group) were enrolled during the study period. Patients in the propofol group had a shorter total procedure time (39.5 vs 59.4 vs 58.1 minutes; P < .001), induction time (4.6 vs 6.3 vs 7.6 minutes; P < .001), recovery time (11.5 vs 29.5 vs 29.2 minutes; P < .001), and discharge time (20.6 vs 34.9 vs 34.7 minutes; P < .001) than patients in the bolus midazolam group and titrated midazolam group. Patients in the propofol group reported higher degrees of satisfaction than patients in the bolus or titrated midazolam plus meperidine groups (9.9 vs 9.6 vs 9.6 [P = .007] and 4.9 vs 4.7 vs 4.8 [P = .008], respectively). Adverse events were not significantly different between groups. CONCLUSIONS: In this randomized trial, propofol was superior to bolus or titrated midazolam in terms of endoscopy unit efficiency and patient satisfaction during outpatient colonoscopy. (Clinical trial registration number: KCT0002805.).

Withdrawal time of 8 minutes is associated with higher adenoma detection rates in surveillance colonoscopy after surgery for colorectal cancer.

BACKGROUND & AIMS: Although several studies have been conducted on the relation between withdrawal time (WT) and adenoma detection rate (ADR) in the intact colonKim, little is known about the optimal WT needed to increase ADR in the postoperative colon. We investigated the association between WT and ADR in surveillance colonoscopy after colorectal cancer (CRC) surgery. METHODS: We conducted a retrospective cohort study of CRC patients who underwent 1st surveillance colonoscopy after curative colectomy. We excluded patients with incomplete inspection of colon during preoperative colonoscopy, inadequate bowel preparation, and total colectomy or subtotal colectomy. The colonoscopies were performed by 8 board-certified colonoscopists. The receiver operating characteristic curve of the WT revealed an optimal cutoff value of 7.8 min for adenoma detection. We divided the colonoscopists into fast and slow colonoscopists using the 8-min WT as cutoff, and compared the ADR between the two groups. RESULTS: We analyzed a total of 1341 patients underwent first surveillance colonoscopy after CRC surgery. Mean WTs by 8 colonoscopists during colonoscopy with and without polypectomy were 18.9 ± 13.7 and 8.1 ± 5.6 min, respectively. ADR varied from 29.3 to 50.6% by individual colonoscopists. Slow colonoscopists showed significantly higher ADR than fast colonoscopists (49.1% vs 32.2%, P < 0.001). The mean WT during colonoscopy without polypectomy for each colonoscopist and the detection rate of all neoplasia were positively correlated (Rs = 0.874, P = 0.005). CONCLUSION: Because patients who underwent colorectal surgery possess high risk of metachronous CRC and adenoma, sufficient WT (8-10 min) is mandatory, despite short length colon due to surgery.

Comparison of bowel-cleansing efficacy of split-dose and same-day dose bowel preparation for afternoon colonoscopy in patients with gastrectomy: a prospective randomized study.

BACKGROUND: A split dose (SPD) of purgative is the recommended bowel-preparation method for colonoscopy, although for colonoscopy scheduled for the afternoon, a same-day dose (SDD) of purgative is recommended. However, it has not been determined whether SPD or SDD is better in patients with gastrectomy who are at high risk of suboptimal bowel cleansing. We compared the bowel-cleansing efficacy of SPD and SDD regimens in patients with gastrectomy who underwent colonoscopy in the afternoon. METHODS: This was a prospective, randomized, assessor-blinded study. For the SDD group, polyethylene glycol (PEG) was ingested on the day of colonoscopy starting at 7 AM. In the SPD group, 2 L PEG was ingested at 9 PM the day before colonoscopy, and the remaining 2 L from 10 AM on the day of colonoscopy. Colonoscopy was performed from 1:30 PM. Before colonoscopy, the participants completed questionnaires asking about bowel-movement kinetics, adverse events, tolerability, overall satisfaction, and willingness to reuse the protocol. The bowel-cleansing efficacy was assessed using the Boston Bowel Preparation Scale. RESULTS: A total of 193 subjects were included (SDD, 95; SPD, 98). The rate of successful bowel cleansing was comparable between the two groups (SDD, 92.6% vs. SPD, 95.9%; P = 0.37). The incidence of adverse events (nausea, vomiting, bloating, abdominal pain, and dizziness/headache) was also comparable between the two groups. However, sleep disturbance was higher in the SPD group (SDD, 10.5% vs. SPD, 25.5%; P = 0.01). Tolerability did not differ between the SDD and SPD groups (satisfaction, P = 0.11; willingness to reuse, P = 0.29). CONCLUSIONS: The bowel-cleansing efficacy, safety profile, and patient tolerability of SDD and SPD were comparable. Both SDD and SPD regimens are feasible bowel-preparation methods for patients with gastrectomy who undergo colonoscopy in the afternoon. TRIAL REGISTRATION: Clinical trial registration number: KCT0002699.

Jumbo biopsy forceps versus cold snares for removing diminutive colorectal polyps: a prospective randomized controlled trial.

BACKGROUND AND AIMS: Cold snare polypectomy (CSP) and jumbo forceps polypectomy (JFP) have been shown to be effective for removing diminutive colorectal polyps (DCPs) (≤5 mm). However, no study has compared complete resection rates between CSP and JFP for DCPs. The aim of this study was to compare the efficacy and safety of JFP with CSP for the removal of DCPs. METHODS: This was a prospective randomized controlled trial from 2 tertiary-care referral centers. A total of 1003 patients were screened, and 169 patients with 196 DCPs were enrolled. The main outcome was complete polyp resection rate. RESULTS: Of 196 diminutive polyps, 177 (90.3%) were adenomatous polyps. The overall complete resection rate was 92.1% (163/177). The complete resection rate was not significantly different between JFP and CSP groups (92.0% vs 92.2%; P = .947). JFP achieved complete resection rates comparable with CSP for polyps >3 mm (90.3% vs 89.8%; P = .928). Polypectomy procedure time, tissue retrieval rate, and rate of postpolypectomy adverse events were not significantly different between the 2 groups. CONCLUSIONS: Both JFP and CSP achieved complete resection rates of >90% for DCPs. Thus, JFP may be considered for polypectomy of DCPs. (International clinical trial registry number: KCT0002805.).

Comparison of Bowel Cleansing Efficacy, Safety, Bowel Movement Kinetics, and Patient Tolerability of Same-Day and Split-Dose Bowel Preparation Using 4 L of Polyethylene Glycol: A Prospective Randomized Study.

BACKGROUND: Split-dose bowel preparation is recommended for morning colonoscopy, although a same-day dose regimen is an alternative for afternoon colonoscopy. Same-day preparation for morning colonoscopy has rarely been evaluated. OBJECTIVE: We compared the bowel cleansing efficacy, bowel movement kinetics, safety profile, and patient tolerability of split-dose and same-day preparation using 4-L polyethylene glycol. DESIGN: This was a prospective, randomized, assessor-blinded study. SETTINGS: This study was performed at a tertiary center in Korea. PATIENTS: Study subjects were randomly assigned to the same-day or split-dose groups. For the same-day dose group, 4 L of polyethylene glycol were ingested on the day of colonoscopy starting at 5:00 AM for morning colonoscopy or 7:00 AM for afternoon colonoscopy. In the split-dose group, 2 L of polyethylene glycol were ingested at 9:00 PM the day before colonoscopy, and the remaining 2 L from 7:00 AM for morning colonoscopy or from 10:00 AM for afternoon colonoscopy. Colonoscopy was performed from 10:00 AM. MAIN OUTCOME MEASURES: The efficacy of bowel cleansing was evaluated using the Boston bowel preparation scale. The participants completed questionnaires asking about adverse events, bowel movement kinetics, and tolerability of the preparation before colonoscopy. RESULTS: A total of 339 subjects were included (same-day dose = 172; split dose = 167). One subject in each group did not undergo colonoscopy. The rate of successful cleansing did not differ between the groups (same-day dose = 98.8% vs split dose = 98.2%; p = 0.681). There were no instances of hemodynamic instability or aspiration in either group. Tolerability, including overall satisfaction and willingness to reuse, were comparable between the groups. LIMITATIONS: This was a single-center study. CONCLUSIONS: The bowel cleansing efficacy, safety profile, and tolerability of same-day dosing with polyethylene glycol were comparable with those of split dose. Therefore, same-day dosing with 4 L of polyethylene glycol is a feasible bowel preparation method. See Video Abstract at http://links.lww.com/DCR/B44. COMPARACIÓN DE LA EFICACIA DE LA LIMPIEZA INTESTINAL, LA SEGURIDAD, LA CINÉTICA DEL MOVIMIENTO INTESTINAL Y LA TOLERABILIDAD DEL PACIENTE DE LA PREPARACIÓN INTESTINAL EN EL MISMO DÍA Y EN DOSIS DIVIDIDAS UTILIZANDO 4 L DE POLIETILENGLICOL: UN ESTUDIO PROSPECTIVO ALEATORIZADO: Se recomienda la preparación del intestino en dosis divididas para la colonoscopia de la mañana, aunque un régimen de una sola dosis el mismo día es una alternativa para la colonoscopia en la tarde. La preparación de una sola dosis el mismo día para la colonoscopia matutina rara vez se ha evaluado.Comparamos la eficacia de la limpieza intestinal, la cinética del movimiento intestinal, el perfil de seguridad y la tolerabilidad del paciente de la dosis dividida y la preparación el mismo día utilizando 4 L de polietilenglicol.Este fue un estudio prospectivo, aleatorizado, cegado por el evaluador.Este estudio se realizó en un centro terciario en Corea.Los sujetos del estudio fueron asignados aleatoriamente a el grupo de una dosis en el mismo día o al grupo de dosis dividida. Para el grupo de dosis del mismo día, se ingirieron 4 L de polietilenglicol el día de la colonoscopia a partir de las 5 a.m. para la colonoscopia de la mañana o las 7 a.m. para la colonoscopia de la tarde. En el grupo de dosis dividida, se ingirieron 2 L de polietilenglicol a las 9 p.m. el día anterior a la colonoscopia, y los otros 2 L restantes a partir de las 7 a.m. para la colonoscopia de la mañana o desde las 10 a.m. para la colonoscopia de la tarde. La colonoscopia se realizó a partir de las 10 a.m.La eficacia de la limpieza intestinal se evaluó mediante la escala de preparación intestinal de Boston. Los participantes completaron cuestionarios preguntando sobre los eventos adversos, la cinética del movimiento intestinal y la tolerabilidad de la preparación antes de la colonoscopia.Se incluyeron un total de 339 sujetos (dosis el mismo día, 172; dosis dividida, 167). Un sujeto en cada grupo no se sometió a colonoscopia. La tasa de limpieza exitosa no difirió entre los grupos (dosis el mismo día, 98.8% versus dosis dividida, 98.2%; p = 0.681). No hubo casos de inestabilidad hemodinámica o aspiración en ninguno de los grupos. La tolerabilidad, incluida la satisfacción general y la voluntad de reutilización, fueron comparables entre los grupos.Este fue un estudio de centro único.La eficacia de la limpieza intestinal, el perfil de seguridad y la tolerabilidad de la dosificación en el mismo día con polietilenglicol fueron comparables con los de la dosis dividida. Por lo tanto, la dosificación en el mismo día con 4 L de polietilenglicol es un método factible de preparación intestinal. Vea el video del resumen en http://links.lww.com/DCR/B44.

CT Versus Endoscopic Ultrasound for Differentiating Small (2-5 cm) Gastrointestinal Stromal Tumors From Leiomyomas.

OBJECTIVE. Abdominal CT or endoscopic ultrasound is recommended for the evaluation of gastric subepithelial tumors. However, few studies have compared the diagnostic performance of these two methods. We compared the diagnostic performance of CT versus endoscopic ultrasound for gastric subepithelial tumors smaller than 5 cm. We also identified significant CT findings associated with the diagnosis of gastrointestinal stromal tumors. MATERIALS AND METHODS. Seventy-one patients with pathologically proven gastric subepithelial tumors were enrolled. We examined the diagnostic performance of CT compared with endoscopic ultrasound. We analyzed CT findings, including the location, long diameter (LD), short diameter (SD), LD-SD ratio, contour, margin, growth pattern, degree and pattern of enhancement, attenuation value, intralesional necrosis, calcification, hemorrhage, surface dimpling, and perilesional lymph node. RESULTS. Endoscopic ultrasound had a sensitivity of 77.6%, specificity of 61.5%, PPV of 90.0%, NPV of 38.1%, and accuracy of 74.6%. CT had a sensitivity of 84.5%, specificity of 53.8%, PPV of 89.1%, NPV of 43.8%, and accuracy of 78.9%. Multivariate analysis revealed that the presence of intralesional necrosis (odds ratio [OR], 10.88; p = 0.037) and an LD-SD ratio less than 1.5 (OR, 32.37; p = 0.002) were independent CT findings for the diagnosis of gastrointestinal stromal tumors. CONCLUSION. CT is as effective as endoscopic ultrasound for the diagnosis of gastric subepithelial tumors smaller than 5 cm. Tumors with intralesional necrosis and an LD-SD ratio less than 1.5 may require further pathologic diagnosis.

Treatment of benign perforations and leaks of the esophagus: factors associated with success after stent placement.

BACKGROUND: Self-expanding metal stent (SEMS) is effective and safe for the treatment of benign esophageal perforations or leaks. The purpose of this study was to identify factors associated with clinical success after SEMS placement. METHODS: Patients who received SEMS placement for treatment of benign esophageal perforations or leaks were retrospectively identified. These patients were analyzed for factors associated with clinical success and complications. RESULTS: A total of 31 patients underwent stent insertion for benign esophageal perforations (n = 11) or anastomotic leaks (n = 20). Clinical success was achieved in twenty-three patients (74.2%) after initial stent insertion. In multivariate analysis, early stent insertion within 1 day was identified as a significant independent predictor of successful sealing (Odds ratio = 3.14, 95% CI 1.36-7.24; p = 0.013). The anastomotic leak group needed a longer stent dwelling time (≥ 4 weeks) compared to the perforation group (75.0% vs. 27.3%, p = 0.022). CONCLUSIONS: Clinical success was significantly associated with early stent insertion. The dwelling time of stent was shorter for benign perforations compared to anastomotic leaks.

Clinical implication of endoscopic gross appearance in superficial esophageal squamous carcinoma: revisited.

BACKGROUND: Standard endoscopic appearance is essential for the diagnosis and treatment of superficial esophageal squamous carcinoma (SESC). The aim of this study was to investigate the association between the endoscopic gross appearance and the clinicopathologic characteristics of SESC. METHODS: We retrospectively analyzed the clinicopathologic characteristics of SESC according to gross endoscopic appearance in 275 patients with SESC that underwent esophagectomy or endoscopic resection (ER). RESULTS: The proportion of type I or type III gross appearance, and that of types IIa, IIb, or IIc, were 26.2 and 73.8%, respectively. Type I or type III gross appearance was significantly associated with the female sex, submucosal invasion, lymphovascular invasion (LVI), and lymph node metastasis (LNM). In addition, younger age, larger tumor size, higher proportion of circumferential extension, type I or type III endoscopic gross appearance, submucosal invasion, moderate or poorly differentiated carcinoma, and LVI were significantly associated with LNM. Multivariate logistic regression analysis determined that independent predictors of LNM in patients with SESC included endoscopic gross appearance, submucosal invasion, and presence of LVI. Additionally, type I or type III endoscopic gross appearance lesions were more likely to have submucosal invasion than types IIa, IIb, or IIc. Risk factors for submucosal invasion included a gross appearance of type I or type III, moderately or poorly differentiated tumors, and presence of LVI. CONCLUSIONS: We found that SESC clinical features are correlated with the endoscopic appearance. Therefore, we suggest that the endoscopic gross appearance may be a candidate for additive criteria in the indications for ER.

Risk-Stratification Model Based on Lymph Node Metastasis After Noncurative Endoscopic Resection for Early Gastric Cancer.

BACKGROUND: Patients with early gastric cancer (EGC) who have undergone noncurative endoscopic resection (ER) generally require additional surgery due to the possibility of lymph node metastasis (LNM). This study aimed to develop a reliable risk-stratification system to predict LNM after noncurative ER for EGC. METHODS: A total of 2368 patients had a diagnosis of EGC and underwent ER. The study analyzed 321 patients who underwent additive gastrectomy and lymph node dissection after noncurative ER. Independent risk factors for LNM were identified and used to develop a risk-stratification system to estimate the relative risk of LNM. RESULTS: Of the 321 patients, 23 (7.2%) had LNM. A logistic regression analysis showed that female sex, lymphovascular invasion (LVI), and a positive vertical margin were significantly associated with LNM. The authors established a risk-stratification system using sex, LVI, and positive vertical margin (area under the receiver-operating characteristic [AUROC] curve, 0.811). The high-risk LNM group (score, ≥ 2 points) showed a significantly higher risk of LNM than the low-risk LNM group (score, <2 points) (14.0 vs 1.2%). No LNM was found in patients with a risk score of zero. After internal and external validation, the AUROC curve for predicting LNM was 0.788 and 0.842, respectively. CONCLUSIONS: The risk-stratification system developed in this study will facilitate identification of patients who should undergo LN dissection after noncurative ER. Although additive surgery should be performed after noncurative ER for patients with a high risk of LNM, a close follow-up visit could be considered for low-risk patients with multiple comorbidities or high operative risks.

Clinicopathologic features of gastric carcinoma with lymphoid stroma in early gastric cancer.

BACKGROUND AND OBJECTIVES: Gastric carcinoma with lymphoid stroma (GCLS) is a rare variant of gastric cancer. The aims of this study were to investigate the clinicopathologic features of GCLS in early gastric cancer (EGC). METHODS: Analysis included 3,385 patients who were diagnosed with EGC after surgery between 2005 and 2012. This study compared GCLS with non-GCLS patients in terms of clinicopathological features including lymph node metastasis (LNM). RESULTS: Forty-one (1.2%) patients were diagnosed as GCLS among those with EGC. When GCLS and non-GCLS patients were compared, the GCLS group showed a greater predominance among males, greater tendency towards proximal location, a more elevated gross appearance, and deeper submucosal invasion. In particular, more than 90% of GCLS cases showed deep submucosal invasion. The LNM rate was significantly lower in GCLS than non-GCLS cases after adjustment for depth of invasion. Among the GCLS group, there was no LNM in the cases with lesions confined to the mucosa or submucosal invasive lesions with tumor size ≤10 mm. CONCLUSIONS: In EGC, GCLS showed deeper submucosal invasion and a lower LNM rate compared with non-GCLS. Thus, clinical considerations of GCLS may be helpful to decide on a specific cancer treatment. J. Surg. Oncol. 2016;114:769-772. © 2016 Wiley Periodicals, Inc.

Clinical Trial: Efficacy of Mosapride Controlled-release and Nortriptyline in Patients With Functional Dyspepsia: A Multicenter, Double-placebo, Double-blinded, Randomized Controlled, Parallel Clinical Study.

Background/Aims: Prokinetic agents and neuromodulators are among the treatment options for functional dyspepsia (FD), but their comparative efficacy is unclear. We aimed to compare the efficacy of mosapride controlled-release (CR) and nortriptyline in patients with FD after 4 weeks of treatment. Methods: Participants with FD were randomly assigned (1:1) to receive mosapride CR (mosapride CR 15 mg and nortriptyline placebo) or nortriptyline (mosapride CR placebo and nortriptyline 10 mg) in double-placebo, double-blinded, randomized controlled, parallel clinical study. The primary endpoint was defined as the proportion of patients with overall dyspepsia improvement after 4 weeks treatment. The secondary endpoints were changes in individual symptom scores, anxiety, depression, and quality of life. Results: One hundred nine participants were recruited and assessed for eligibility, and 54 in the mosapride CR group and 50 in the nortriptyline group were included in the modified intention-to-treat protocol. The rate of overall dyspepsia improvement was similar between groups (53.7% vs 54.0%, P = 0.976). There was no difference in the efficacy of mosapride CR and nortriptyline in a subgroup analysis by FD subtype (59.3% vs 52.5% in postprandial distress syndrome, P = 0.615; 44.4% vs 40.0% in epigastric pain syndrome, P = > 0.999; 50.0% vs 59.1% in overlap, P = 0.565; respectively). Both treatments significantly improved anxiety, depression, and quality of life from baseline. Conclusion: Mosapride CR and nortriptyline showed similar efficacy in patients with FD regardless of the subtype. Both treatments could be equally helpful for improving quality of life and psychological well-being while also relieving dyspepsia.

Efficacy of Tegoprazan in Patients With Functional Dyspepsia: A Prospective, Multicenter, Single-arm Study.

Background/Aims: Acid-suppressive drugs, such as proton pump inhibitors (PPIs), are treatment options for functional dyspepsia (FD). However, the efficacy of potassium-competitive acid blockers (P-CABs) in treating FD has not yet been established. This prospective multicenter clinical trial-based study aimed to assess the efficacy and safety of tegoprazan as a P-CAB treatment in patients with FD. Methods: FD was diagnosed using the Rome IV criteria. All patients received tegoprazan 50 mg once daily for 8 weeks. Dyspeptic symptoms were assessed using a dyspepsia symptom questionnaire (5-point Likert scale, Nepean Dyspepsia Index-Korean [NDI-K], and gastroesophageal reflux disease-health-related quality of life [GERD-HRQL]). The main outcome was satisfactory symptom relief rates at 8 weeks. Results: In this study, from the initial screening of 209 patients, 173 were included in the per-protocol set analysis. Satisfactory symptom relief rates at 8 and 4 weeks were 86.7% and 74.6%, respectively. In addition, the NDI-K and GERD-HRQL scores significantly improved at 8 and 4 weeks compared with the baseline scores. The efficacy of tegoprazan was not influenced by the FD subtype or Helicobacter pylori status. In patients with overlapping FD and GERD, there was a greater improvement in the NDI-K and GERD-HRQL scores than in patients with FD symptoms only. No serious drug-related adverse events occurred during this study. Conclusion: Tegoprazan (50 mg) administered once daily provided satisfactory symptom relief for FD.

Signet ring cell mixed histology may show more aggressive behavior than other histologies in early gastric cancer.

BACKGROUND: Signet ring cell carcinoma (SRC) of the stomach is known to have different microscopic and biologic characteristics compared to non-SRC. The pathologic report has documented partly SRC component with main histologies. However, the clinical significance of SRC mixture has not been reported. Aim was to investigate clinicopathologic features of mixed-SRC histology in early gastric cancer (EGC). METHODS: Two thousand two hundred eight patients were diagnosed with EGC and underwent surgery. The patients were divided into three groups such as adenocarcinoma with partly SRC (mixed-SRC group), only adenocarcinoma (adenocarcinoma group), and SRC (SRC group). Clinicopathologic characteristics were compared. RESULTS: The SRC group was more associated with younger age, female, mid-body, mucosa-confined, depressed type, lower lymph node metastasis (LNM), lower lymphovascular invasion, and better survival rate than adenocarcinoma group. The mixed-SRC group was more associated with younger age, female, upper-body, and depressed type than adenocarcinoma group, similar to SRC group. However, the mixed-SRC group showed more submucosal invasion, larger size, and higher LNM than other groups. The mixed-SRC component was one of the independent risk factors of LNM. CONCLUSIONS: Mixed-SRC histology in EGC showed more aggressive behavior than other histologies. Clinical considerations of mixed-SRC histology may be helpful to decide on a specific cancer treatment.

Is the 7th TNM edition suitable for biological predictor in early gastric cancer?

BACKGROUND/AIMS: The clinical and prognostic value of the previous node classification of TNM staging in early gastric cancer (EGC) has been less definitive. The aim was to assess the suitability of the revised node staging for prediction of clinical behavior of EGC. METHODOLOGY: Between 2005 and 2008, 1,845 patients were diagnosed with EGC and underwent surgery at Severance Hospitals. Clinicopathological characteristics were analyzed with comparisons between sixth and seventh TNM staging. RESULTS: When comparing IB with IIA upstaged based on seventh staging, poor differentiation, signet ring cell, diffuse, undifferentiated types, perineural invasion (PNI), larger size and younger age, were more significantly associated with IIA. Clinicopathological factors were compared between N0/N1 and N2/N3 based on both staging. In mucosal cancer, younger age, diffuse and undifferentiated types were more significantly associated with N2/N3 based on seventh staging. In submucosal cancer, larger size, poor differentiation, signet ring cell, diffuse, undifferentiated types, PNI and deeper submucosal invasion, were more significantly associated with N2/N3 based on seventh staging. CONCLUSIONS: Upstaging in EGC based on the revised TNM staging reflects more aggressive biological behavior of cancer. The new TNM staging system may be informative in prediction of biological behavior of EGC as well as prognosis and survival.

Real-world Prescription Patterns and Patient Satisfaction Regarding Maintenance Therapy of Gastroesophageal Reflux Disease: An Observational, Cross-sectional, Multicenter Study.

Background/Aims: Gastroesophageal reflux disease (GERD) is a common chronic gastrointestinal disorder that typically requires long-term maintenance therapy. However, little is known about patient preferences and satisfaction and real-world prescription patterns regarding maintenance therapy for GERD. Methods: This observational, cross-sectional, multicenter study involved patients from 18 referral hospitals in Korea. We surveyed patients who had been prescribed proton pump inhibitors (PPIs) for GERD for at least 90 days with a minimum follow-up duration of 1 year. The main outcome was overall patient satisfaction with different maintenance therapy modalities. Results: A total of 197 patients were enrolled. Overall patient satisfaction, patient preferences, and GERD health-related quality of life scores did not significantly differ among the maintenance therapy modality groups. However, the on-demand therapy group experienced a significantly longer disease duration than the continuous therapy group. The continuous therapy group demonstrated a lower level of awareness of potential adverse effects associated with PPIs than the on-demand therapy group but received higher doses of PPIs than the on-demand therapy group. The prescribed doses of PPIs also varied based on the phenotype of GERD, with higher doses prescribed for non-erosive reflux disease than erosive reflux disease. Conclusion: Although overall patient satisfaction did not significantly differ among the different PPI maintenance therapy modality groups, awareness of potential adverse effects was significantly different between the on-demand and continuous therapy groups.

On-demand Versus Continuous Maintenance Treatment With a Proton Pump Inhibitor for Mild Gastroesophageal Reflux Disease: A Prospective Randomized Multicenter Study.

Background/Aims: It remains unclear which maintenance treatment modality is most appropriate for mild gastroesophageal reflux disease (GERD). We aimed to compare on-demand treatment with continuous treatment using a proton pump inhibitor (PPI) in the maintenance treatment for patients with non-erosive GERD or mild erosive esophagitis. Methods: Patients whose GERD symptoms improved after 4 weeks of standard dose PPI treatment were prospectively enrolled at 25 hospitals. Subsequently, the enrolled patients were randomly assigned to either an on-demand or a continuous maintenance treatment group, and followed in an 8-week interval for up to 24 weeks. Results: A total of 304 patients were randomized to maintenance treatment (continuous, n = 151 vs on-demand, n = 153). The primary outcome, the overall proportion of unwillingness to continue the assigned maintenance treatment modality, failed to confirm the non-inferiority of on-demand treatment (45.9%) compared to continuous treatment (36.1%). Compared with the on-demand group, the GERD symptom and health-related quality of life scores significantly more improved and the overall satisfaction score was significantly higher in the continuous treatment group, particularly at week 8 and week 16 of maintenance treatment. Work impairment scores were not different in the 2 groups, but the prescription cost was less in the on-demand group. Serum gastrin levels significantly elevated in the continuous treatment group, but not in the on-demand group. Conclusions: Continuous treatment seems to be more appropriate for the initial maintenance treatment of non-erosive GERD or mild erosive esophagitis than on-demand treatment. Stepping down to on-demand treatment needs to be considered after a sufficient period of continuous treatment.