Fecal Signatures of Streptococcus anginosus and Streptococcus constellatus for Noninvasive Screening and Early Warning of Gastric Cancer.

BACKGROUND & AIMS: Most patients with gastric cancer (GCa) are diagnosed at an advanced stage. We aimed to investigate novel fecal signatures for clinical application in early diagnosis of GCa. METHODS: This was an observational study that included 1043 patients from 10 hospitals in China. In the discovery cohort, 16S ribosomal RNA gene analysis was performed in paired samples (tissues and feces) from patients with GCa and chronic gastritis (ChG) to determine differential abundant microbes. Their relative abundances were detected using quantitative real-time polymerase chain reaction to test them as bacterial candidates in the training cohort. Their diagnostic efficacy was validated in the validation cohort. RESULTS: Significant enrichments of Streptococcus anginosus (Sa) and Streptococcus constellatus (Sc) in GCa tumor tissues (P < .05) and feces (P < .0001) were observed in patients with intraepithelial neoplasia, early and advanced GCa. Either the signature parallel test Sa∪Sc or single signature Sa/Sc demonstrated superior sensitivity (Sa: 75.6% vs 72.1%, P < .05; Sc: 84.4% vs 64.0%, P < .001; and Sa∪Sc: 91.1% vs 81.4%, P < .01) in detecting early GCa compared with advanced GCa (specificity: Sa: 84.0% vs 83.9%, Sc: 70.4% vs 82.3%, and Sa∪Sc: 64.0% vs 73.4%). Fecal signature Sa∪Sc outperformed Sa∪CEA/Sc∪CEA in the discrimination of advanced GCa (sensitivity: 81.4% vs 74.2% and 81.4% vs 72.3%, P < .01; specificity: 73.4% vs 81.0 % and 73.4% vs 81.0%). The performance of Sa∪Sc in the diagnosis of both early and advanced GCa was verified in the validation cohort. CONCLUSION: Fecal Sa and Sc are noninvasive, accurate, and sensitive signatures for early warning in GCa. (ClinicalTrials.gov, Number: NCT04638959).

Evaluation of a novel disposable esophagogastroduodenoscopy system in emergency, bedside, and intraoperative settings: Pilot study (with videos).

OBJECTIVES: The disposable esophagogastroduodenoscopy (EGD) system is a novel endoscopic device which is highly portable and is designed to eliminate the risk of cross-infection caused by reusable EGD. This study aimed to investigate the feasibility and safety of disposable EGD in emergency, bedside, and intraoperative settings. METHODS: This was a prospective, single-center, noncomparative study. Disposable EGD was used for emergency, bedside, and intraoperative endoscopies in 30 patients. The primary end-point was the technical success rate of the disposable EGD. Secondary end-points included technical performance indicators including clinical operability, image quality score, procedure time, the incidence of device malfunction and/or failure, and the incidence of adverse events. RESULTS: A total of 30 patients underwent diagnosis and/or treatment with disposable EGD. Therapeutic EGD was performed on 13/30 patients, including hemostasis (n = 3), foreign body retrieval (n = 6), nasoenteric tube placement (n = 3), and percutaneous endoscopic gastrostomy (n = 1). The technical success rate was 100%: all procedures and indicated interventions were completed without changing to a conventional upper endoscope. The mean image quality score obtained immediately after procedure completion was 3.72 ± 0.56. The mean (± SD) procedure time was 7.4 (± 7.6) min. There were no device malfunctions or failures, device-related adverse events, or overall adverse events. CONCLUSION: The disposable EGD may be a feasible alternative to the traditional EGD in emergency, bedside, and intraoperative settings. Preliminary data show that it is a safe and effective tool for diagnosis and treatment in emergency and bedside upper gastrointestinal cases. TRIAL REGISTRATION: Chinese Clinical Trial Registry (Trial ID: ChiCTR2100051452, https://www.chictr.org.cn/showprojen.aspx?proj=134284).

Endoscopic resection via antral submucosal tunneling for en bloc removal of tumors in the duodenal bulb.

To overcome difficulties in the removal of duodenal bulb lesions, especially those in anatomically challenging locations, we developed the endoscopic resection via antral submucosal tunneling (ERAST) technique. In this study, we evaluated the feasibility and safety of ERAST for the removal of superficial and subepithelial lesions in the duodenal bulb. This was a single-center retrospective study of 10 patients with lesions in the bulb. Submucosal tunneling from the gastric antrum to the duodenum was performed to facilitate en bloc tumor resection in the bulb. The en bloc resection rate, postoperative bleeding, and perforation were the primary endpoints. Ten lesions (four superficial and six subepithelial), with an average size of 19.1 ± 9.2 mm, were resected en bloc by ERAST. Esophagogastroduodenoscopy follow-up after 2 months indicated complete wound healing in all patients. In our primary experience, ERAST was found to be a feasible and safe endoscopic resection technique for the removal of lesions in the duodenal bulb, especially those that are difficult to access.

Standing-type magnetically guided capsule endoscopy versus gastroscopy for gastric examination: multicenter blinded comparative trial.

AIM: To compare feasibility and safety after gastrointestinal checkup by standing-type magnetically controlled capsule endoscopy (SMCE) and conventional gastroscopy. METHODS: This was a prospective multicenter, blinded study that compared SMCE with gastroscopy in patients from April 2018 to July 2018. All patients first underwent SMCE and then subsequently had gastroscopy with i.v. anesthesia. We calculated the compliance rates of gastric lesion detection by SMCE using gastroscopy as the standard. Capsule retention rate, incidence of adverse events, and patient satisfaction were documented throughout the study. RESULTS: One hundred and sixty-one patients who completed SMCE and gastroscopy were included in the analysis. Positive compliance rate among SMCE and gastroscopy was 92.0% (95% CI: 80.77%-97.78%). Negative compliance rate was 95.5% (89.80%, 98.52%). Moreover, overall compliance rate was 94.41% (89.65%, 97.41%). Sixty-four pathological outcomes were identified. Of these 64 outcomes, 50 were detected by both procedures. The gastroscopy method neglected seven findings (such as five erosions, one polyp, and one ulcer). Furthermore, SMCE also overlooked seven lesions (i.e. one erosion, two polyps, one atrophy, and three submucosal tumors). Capsule retention or related adverse events were not reported. CONCLUSION: Standing-type magnetically controlled capsule endoscopy provides equivalent agreement with gastroscopy and may be useful for screening of gastric illnesses without any anesthesia.

Impact of capsule endoscopy on prevention of postoperative recurrence of Crohn's disease.

BACKGROUND AND AIMS: Capsule endoscopy (CE) can detect lesions outside the scope of ileocolonoscopy in postoperative patients with Crohn's disease (CD). However, the impact of such findings on patient outcomes remains unknown. This study is intended to evaluate the impact of CE findings on clinical management and outcomes in asymptomatic patients with CD without pharmacologic prophylaxis after ileocolonic resection. METHODS: In this retrospective cohort study, 37 patients (group 1) received ileocolonoscopy together with CE within 1 year after surgery, whereas 46 patients (group 2) only received ileocolonoscopy. Patients with endoscopic recurrence detected by either ileocolonoscopy or CE received pharmacologic therapy with azathioprine or infliximab. One year later, disease activity was re-evaluated. RESULTS: In group 1, all patients with ileocolonoscopy-identified recurrence also had CE-identified recurrence. In addition, CE detected endoscopic recurrence in 11 patients missed by ileocolonoscopy. Endoscopic remission identified by ileocolonoscopy was confirmed by CE in 13 patients. One year later, endoscopic remission identified by ileocolonoscopy was maintained in all 24 patients, and none had clinical recurrence. Conversely, in group 2, of those with ileocolonoscopy-identified remission, both ileocolonoscopy-identified recurrence and clinical recurrence occurred in 9 of 31 patients 1 year later. The total clinical recurrence rate was 2.7% (1/37) in group 1 versus 21.7% (10/46) in group 2 (P = .019). CONCLUSIONS: If endoscopic remission identified by ileocolonoscopy was confirmed by CE, patients could remain free of pharmacologic prophylaxis. If recurrence outside the scope of ileocolonoscopy was detected by CE, initiation of active pharmacologic therapy would be needed.

Risk factors associated with the detection and missed diagnosis of colorectal flat adenoma: a Chinese multicenter observational study.

OBJECTIVES: Flat colorectal adenomas have a high risk of malignancy; however, their detection is often difficult due to their flat morphology. In this retrospective, large-scale study, we investigated the prevalence and characteristics of flat adenomas in a population in China. METHODS: We analyzed the data collected for 16951 consecutive patients who underwent colonoscopy at four participating hospitals between September 2013 and September 2015. All colonoscopies were performed without magnification. RESULTS: Among the 1,6951 patients, 2938 (17.3%) had adenoma and 796 (4.7%) had flat adenomas. The detection of flat adenoma showed a weak correlation with the detection of adenoma (r = 0.666). Multivariable logistic regression analysis revealed the following independent factors influencing the detection of flat adenomas: patient-related factors of age, presence of warning symptoms, history of adenomas and bowel preparation as well as endoscopist-related factors of endoscopist's level of proficiency, number of colonoscopy operators and withdrawal time. CONCLUSIONS: The prevalence of flat adenomas in our study on Chinese patients was consistent with that reported from other countries. Factors conducive to the detection of flat adenomas were patient age of > 60 years, warning symptoms, history of adenoma, good bowel preparation, experienced endoscopist, single-operator colonoscopy and colonoscopy withdrawal time of >6 min.

A modified endoscopic method for resection of gastric submucosal tumor.

BACKGROUND AND OBJECTIVE: Endoscopic mucosa-sparing lateral dissection (EMSLD) was developed by our group, and is used to remove gastric submucosal tumor (SMT). This study aims to evaluate the feasibility and safety of this method. METHODS: This retrospective study included 25 patients who underwent EMSLDs at an endoscopy center as a national key unit in china from October 2015 to July 2016. The main data collected were the size of the gastric SMT, its location and origin, en bloc resection rate, operating time, intraoperative and postoperative complications, hospitalization expense, hospital days, and follow-up after hospital discharge. RESULTS: The mean (SD) size of the gastric SMTs was 18.3 (5.9) mm; 96% (24/25) of the tumors originated in the muscularis propria; and 64% (16/25) and 28% (7/25) were located in the gastric fundus and gastric body, respectively. The rate of en bloc resection was 96% (24/25), and the rate of intraoperative perforations due to endoscopic full-thickness resection was 48% (12/25). All wounds and perforations were effectively closed using endoscopic clips combined with the retained mucosa. The mean operative time was 74.2 (38.0) min. Delayed bleeding and perforation were not observed. CONCLUSION: Endoscopic mucosa-sparing lateral dissection is safe and feasible for the removal of gastric SMTs. The wound can be effectively closed using the retained mucosa and endoscopic clips, even if perforation has occurred. EMSLD provides an alternative to the resection of gastric SMTs, especially for tumors with a risk of intraoperative perforation.

Effectiveness and safety of endoscopic resection for gastric GISTs: a systematic review.

AIMS: To evaluate the effectiveness and safety of endoscopic resection for gastric gastrointestinal stromal tumors (GISTs). MATERIAL AND METHODS: The effectiveness and safety of endoscopic resection were mainly assessed by complete resection rate, postoperative adverse event rate, and recurrence rate. Moreover, a comparison of endoscopic with laparoscopic resection for gastric GISTs was made through weighted mean difference by STATA 12.0 with regard to operation time, blood loss, and length of stay after including patients who underwent endoscopic or laparoscopic resection for gastric GISTs in the comparative studies. RESULTS: Eleven studies investigating endoscopic resection for GISTs were included. For stromal tumors <2 cm in average diameters the pooled rates of complete resection, postoperative adverse events and recurrence were 0.97, 0.08, and 0.03, respectively. Only five retrospective studies directly compared endoscopic with laparoscopic resection for gastric GISTs with average diameters from 1.1 cm to 3.8 cm, and endoscopic resection had a shorter operation time than laparoscopic resection, but there were no significant differences in intraoperative blood loss, length of stay, postoperative complications, and postoperative recurrence rates between the two approaches. CONCLUSIONS: Endoscopic resection is predominantly tried for gastric GISTs of relatively small size. It seems effective and safe for gastric GISTs <2 cm in average diameter, with relatively short operation times.

Comparison of endoscopic submucosal tunneling dissection and thoracoscopic enucleation for the treatment of esophageal submucosal tumors.

BACKGROUND AND AIMS: Endoscopic submucosal tunneling dissection (ESTD) has been proved to be safe and effective for removal of esophageal submucosal tumors (SMTs) and can maintain the mucosal integrity compared with other endoscopic methods. The aim of the study was to estimate the safety and efficacy of ESTD as well as compare its efficacy with thoracoscopic enucleation for esophageal SMTs, which is used increasingly as a minimally invasive approach. METHODS: We retrospectively collected the clinical data of patients with esophageal SMTs <40 mm who underwent ESTD or thoracoscopic enucleation at Nanfang Hospital between January 2008 and August 2016. Epidemiologic data (sex, age), tumor location, tumor size, en bloc resection rate, adverse events, pathologic results, length of postoperative hospital stay, and cost were compared between ESTD and thoracoscopic enucleation. RESULTS: A total of 126 patients were included. A total of 74 patients underwent ESTD, and the other 52 underwent thoracoscopic enucleation. There was no significant difference between the 2 groups in sex, age, tumor size, hospitalization expense, infection, adverse events, and en bloc resection rate (P < .05). However, patients in the ESTD group had a shorter operating time, less estimated blood loss, shorter length of postoperative hospital stay, and lower chest pain level (P < .05). Kaplan-Meier curves for disease-free survival also showed no statistically significant difference between ESTD and thoracoscopic enucleation groups during the median follow-up of 19.5 and 42 months, respectively. CONCLUSIONS: The treatment efficacy was comparable between the ESTD and thoracoscopic enucleation for esophageal SMTs <40 mm. However, there was a significant advantage in the ESTD group for a shorter operating time, reduced postoperative chest pain, and shorter hospitalization.

Comparison of the diagnostic efficacy of white light endoscopy and magnifying endoscopy with narrow band imaging for early gastric cancer: a meta-analysis.

OBJECTIVE: Magnifying endoscopy with narrow band imaging (ME-NBI) is widely used in gastroscopy, especially in the diagnosis of early gastric cancer. The purpose of this meta-analysis is to compare the diagnostic efficacy of white light imaging (WLI) and that of ME-NBI for early gastric cancer. METHODS: PubMed/MEDLINE, EMBASE, and the Cochrane Library were searched to identify studies which met the inclusion criteria. A random-effects model was used to calculate overall sensitivity, specificity, and the area under the receiver operating characteristic curve (AUC) to assess the diagnostic efficacy of WLI and ME-NBI in early gastric cancer. Sensitivity analysis was performed to assess the stability of the results. RESULTS: Ten studies met the inclusion criteria, and included 1724 patients and 2153 lesions. The pooled sensitivity, specificity, and AUC for the diagnosis of early gastric cancer using WLI were 0.48 [95 % confidence interval (CI) 0.39-0.57; I (2) = 78.6 %], 0.67 (95 % CI 0.62-0.71; I (2) = 81.9 %), and 0.62, respectively. The pooled sensitivity, specificity, and AUC using ME-NBI were 0.83 (95 % CI 0.79-0.87; I (2) = 79.8 %), 0.96 (95 % CI 0.95-0.97; I (2) = 89.3 %), and 0.96, respectively. The studies showed a high degree of heterogeneity. Further sensitivity analysis was mainly performed for the studies of small lesions (mean size 10 mm or less) and the studies with a the score of 12 points or greater in the literature quality assessment, and the AUCs for ME-NBI for diagnosis of early gastric cancer were between 0.93 and 0.98, which suggested that the diagnostic value was still high and stable. CONCLUSION: Compared with WLI, ME-NBI can effectively diagnose early gastric cancer.

Association between regular proton pump inhibitors use and cardiovascular outcomes: A large prospective cohort study.

BACKGROUND: Proton pump inhibitors (PPIs) are widely prescribed for gastroesophageal reflux disease and peptic ulcer disease. However, the association between the regular PPIs use and the risk of cardiovascular disease (CVD) outcomes remains unclear. We aimed to determine whether regular proton pump inhibitors (PPIs) use is associated with an altered incidence of cardiovascular disease (CVD) in the general population. METHODS: This prospective cohort study included 459,207 participants (mean [SD] age, 56.2 [8.1] years) from the UK Biobank study without prevalent CVD who enrolled between 2006 and 2010 and were followed until 2018. Hazard ratios (HRs) and 95% confidence intervals (CIs) for incident CVD and its components (coronary heart disease [CHD], stroke, heart failure, atrial fibrillation, and venous thromboembolism) were obtained using Cox proportional hazards models with adjustment for potential confounding factors, including demographic factors, lifestyle behaviors, prevalent comorbidities, and clinical indicators for PPIs use. RESULTS: During the follow-up period, we recorded 26,346 incident CVD events (including 13,749 CHD events, 4144 stroke events, 5812 atrial fibrillation events, 1159 heart failure events, and 4206 venous thromboembolism events). The fully adjusted HRs (and 95% CIs) associated with PPIs users compared to nonusers were 1.44 (95% CI 1.39-1.50) for incident CVD, 1.65 (95% CI 1.57-1.74) for CHD, 1.21 (95% CI 1.09-1.33) for stroke, 1.17 (95% CI 1.08-1.28) for atrial fibrillation, 1.61 (95% CI 1.37-1.89) for heart failure, and 1.36 (95% CI 1.24-1.50) for venous thromboembolism. CONCLUSIONS: Regular PPIs use was associated with higher risk of CVD outcomes. Clinicians should therefore exercise caution when prescribing PPIs.

Effectiveness and safety of Moluodan in the treatment of precancerous lesions of gastric cancer: A randomized clinical trial.

OBJECTIVE: To investigate the clinical potential and safety of Moluodan to reverse gastric precancerous lesions. METHODS: Patients aged 18-70 years diagnosed with moderate-to-severe atrophy and/or moderate-to-severe intestinal metaplasia, with or without low-grade dysplasia, and negative for Helicobacter pylori were recruited in this randomized, double-blind, parallel-controlled trial. The primary outcome was the improvement of global histological diagnosis at 1-year follow-up endoscopy using the operative link for gastritis assessment, the operative link for gastric intestinal metaplasia assessment, and the disappearance rate of dysplasia. RESULTS: Between November 3, 2017 and January 27, 2021, 166 subjects were randomly assigned to the Moluodan group, 168 to the folic acid group, 84 to the combination group, and 84 to the high-dose Moluodan group. The improvement in global histological diagnosis was achieved in 60 (39.5%) subjects receiving Moluodan, 59 (37.8%) receiving folic acid, 26 (32.1%) receiving the combined drugs, and 36 (47.4%) receiving high-dose Moluodan. Moluodan was non-inferior to folic acid (95% confidence interval: -9.2 to 12.5; P = 0.02). High-dose Moluodan had a trend for better protective efficacy, though there was no statistical significance. The disappearance rate of dysplasia was 82.8% in the Moluodan group, which was superior to folic acid (53.9%; P = 0.006). No drug-related serious adverse events were observed. CONCLUSIONS: One pack of Moluodan three times daily for 1 year was safe and effective in reversing gastric precancerous lesions, especially dysplasia. Doubling its dose showed a better efficacy trend.

Effects of interleukin-4 or interleukin-10 gene therapy on trinitrobenzenesulfonic acid-induced murine colitis.

BACKGROUND: Inflammatory bowel disease (IBD) is characterized by disturbance of pro-inflammatory cytokines and anti-inflammatory cytokines. Previous studies have demonstrated the effect of anti-inflammatory cytokines, such as interleukin-10 (IL-10) or IL-4 on IBD, but their data were controversial. This study further investigated the effect of IL-4 (IL-4), IL-10 and their combination on treatment of trinitrobenzenesulfonic acid (TNBS)-induced murine colitis. METHODS: pcDNA3.0 carrying murine IL-4 or IL-10 cDNA was encapsulated with LipofectAMINE 2000 and intraperitoneally injected into mice with TNBS-induced colitis. The levels of intestinal IL-4 and IL-10 mRNA were confirmed by quantitative-RT-PCR. Inflamed tissues were assessed by histology and expression of interferon (IFN)-γ, tumor necrosis factor (TNF)-α and IL-6. RESULTS: The data confirmed that IL-4 or IL-10 over-expression was successfully induced in murine colon tissues after intraperitoneal injection. Injections of IL-4 or IL-10 significantly inhibited TNBS-induced colon tissue damage, disease activity index (DAI) and body weight loss compared to the control mice. Furthermore, expression of IFN-γ, TNF-α and IL-6 was markedly blocked by injections of IL-4 or IL-10 plasmid. However, there was less therapeutic effect in mice injected with the combination of IL-4 and IL-10. CONCLUSIONS: These data suggest that intraperitoneal injection of IL-4 or IL-10 plasmid was a potential strategy in control of TNBS-induced murine colitis, but their combination had less effect.

Causal associations between inflammatory bowel disease and anxiety: A bidirectional Mendelian randomization study.

BACKGROUND: Anxiety is common in patients with inflammatory bowel disease (IBD), including those with ulcerative colitis (UC) and Crohn's disease (CD); however, the causal relationship between IBD and anxiety remains unknown. AIM: To investigate the causal relationship between IBD and anxiety by using bidirectional Mendelian randomization analysis. METHODS: Single nucleotide polymorphisms retrieved from genome-wide association studies (GWAS) of the European population were identified as genetic instrument variants. GWAS statistics for individuals with UC (6968 patients and 20464 controls; adults) and CD (5956 patients and 14927 controls; adults) were obtained from the International IBD Genetics Consortium. GWAS statistics for individuals with anxiety were obtained from the Psychiatric Genomics Consortium (2565 patients and 14745 controls; adults) and FinnGen project (20992 patients and 197800 controls; adults), respectively. Inverse-variance weighted was applied to assess the causal relationship, and the results were strengthened by heterogeneity, pleiotropy and leave-one-out analyses. RESULTS: Genetic susceptibility to UC was associated with an increased risk of anxiety [odds ratio: 1.071 (95% confidence interval: 1.009-1.135), P = 0.023], while genetic susceptibility to CD was not associated with anxiety. Genetic susceptibility to anxiety was not associated with UC or CD. No heterogeneity or pleiotropy was observed, and the leave-one-out analysis excluded the potential influence of a particular variant. CONCLUSION: This study revealed that genetic susceptibility to UC was significantly associated with anxiety and highlighted the importance of early screening for anxiety in patients with UC.

[Control study on colonoscopy skills acquiring from endoscopic simulation system transfering to patients].

OBJECTIVE: To explore the feasibility of transferring the skills from the AccuTouch flexible endoscopy simulator colonoscopy training to clinical practices. METHODS: The novice colonoscopies were divided into 2 groups.Group A (control group) including 4 trainees for traditional training, Group B (experimental group) including 4 trainees for simulator training. After training, we compared the number of cases for achieving independent competence, assisted competence and incompetence in the first ten patients. RESULTS: No significant differences existed between two groups in terms of age and gender (both P > 0.05). Significant differences existed in educational background and the controlled group was better than the experimental group (Z = -2.005, P = 0.04). The cases of independent completion, assisted competence and incompetence of the control and experimental groups were 2, 4, 9 and 21, 29, 15 respectively. Rank tests show that the simulator training was better than the traditional counterpart (average rank: 56.14 vs 24.86, Z = -6.393, P = 0.00). CONCLUSIONS: The skills acquired from AccuTouch Endoscopy Simulator may be well transferred into the clinical colonoscopy environment. It clearly supports the scheme of integrating simulator training into colonoscopic education curricula.

Natural Orifice Translumenal Endoscopic Surgery (NOTES): patients' perceptions and attitudes.

BACKGROUND: Natural orifice translumenal endoscopic surgery (NOTES) has generated a surge of enthusiasm among researchers by virtue of its challenge to the dogma and potential benefits. However, no data is available in the medical literature about NOTES' acceptance by patients in Asia. The aim of the study is to survey patients' perceptions and attitudes towards NOTES. METHODS: It is a questionnaire-based multi-center study on inpatient subjects with various gastrointestinal disorders from 14 hospitals in 12 cities of China. Procedural details with the benefits and risks of NOTES, laparoscopic surgery, and conventional surgery were explained to all registered candidates. They were required to choose and cite reasons for adopting one of the above three surgical techniques as the preferred mode of treatment. The reasons for selection of the surgical treatment were: safety, efficacy, cost, postoperative pain, abdominal wounds, and scarring. RESULTS: There were 1,797 cases, including 976 (54.3%) males and 821 females (45.7%). Based on their comprehension of the procedure, 802 (44.6%) patients opted for NOTES, 757 (42.1%) for laparoscopic surgery, and 238 (13.2%) for conventional surgery. NOTES was mainly selected by the young and educated persons, especially females and by those with past exposure to laparoscopy or conventional surgery. The choice of treatment was significantly correlated with age (P=0.0021), education (P=0.0209), past medical history (laparoscopy, P=0.0134; open surgery, P<0.0001), and department of admission (P=0.0173). The preference for NOTES was based on safety (37.3%), cost (17.6%), elimination of postoperative scars (16.1%), abdominal wounds (16.0%), and efficacy (13.1%). CONCLUSIONS: The vast majority of patients prefer mini-invasive surgery to conventional surgery. The potential recipients of NOTES are educated and younger age groups. However, a few consider NOTES as a safe and effective intervention at present.

Efficacy and safety of lubiprostone for the treatment of functional constipation in Chinese adult patients: A multicenter, randomized, double-blind, placebo-controlled trial.

OBJECTIVES: Functional constipation is a gastrointestinal disorder prevalent around the world. Lubiprostone is the first locally acting type-2 chloride channel activator to be used for treating constipation. This study aimed to evaluate the efficacy and safety of lubiprostone in Chinese adults with functional constipation. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study. Patients with functional constipation were randomized to receive either lubiprostone (24 mcg twice daily) or placebo for 4 weeks. The primary end-point was the frequency of spontaneous bowel movements (SBMs) during the first week of treatment. The secondary end-points included the median time of the first SBM, SBM frequency at weeks 2, 3 and 4, weekly response rate of SBMs, the stool consistency score and average number of complete spontaneous bowel movements (CSBMs) per week. RESULTS: In total, 259 patients were randomized, with 130 in the lubiprostone group and 129 in the placebo group. SBM frequency was higher in the lubiprostone group (4.88 ± 4.09/wk) than that in the placebo group (3.22 ± 2.01/wk) at week 1 (P < 0.0001). SBM frequency was also higher in the lubiprostone group at weeks 2, 3 and 4. The average number of CSBMs and the stool consistency score in the lubiprostone group were significantly higher than that in the placebo group at each week. No drug-related serious adverse events (AEs) occurred. The most commonly reported AE was nausea. CONCLUSION: Lubiprostone was superior to placebo in treating Chinese patients with functional constipation, together with good safety profile.

Berberine versus placebo for the prevention of recurrence of colorectal adenoma: a multicentre, double-blinded, randomised controlled study.

BACKGROUND: Chemoprevention of colorectal adenoma and colorectal cancer remains an important public health goal. The present study aimed to investigate the clinical potential and safety of berberine for prevention of colorectal adenoma recurrence. METHODS: This double-blind, randomised, placebo-controlled trial was done in seven hospital centres across six provinces in China. Individuals aged 18-75 years who had at least one but no more than six histologically confirmed colorectal adenomas that had undergone complete polypectomy within the 6 months before recruitment were recruited and randomly assigned (1:1) to receive berberine (0·3 g twice daily) or placebo tablets via block randomisation (block size of six). Participants were to undergo a first follow-up colonoscopy 1 year after enrolment, and if no colorectal adenomas were detected, a second follow-up colonoscopy at 2 years was planned. The study continued until the last enrolled participant reached the 2-year follow-up point. All participants, investigators, endoscopists, and pathologists were blinded to treatment assignment. The primary efficacy endpoint was the recurrence of adenomas at any follow-up colonoscopy. Analysis was based on modified intention-to-treat, with the full analysis set including all randomised participants who received at least one dose of study medication and who had available efficacy data. The study is registered with ClinicalTrials.gov, number NCT02226185; the trial has ended and this report represents the final analysis. FINDINGS: Between Nov 14, 2014, and Dec 30, 2016, 553 participants were randomly assigned to the berberine group and 555 to the placebo group. The full analysis set consisted of 429 participants in the berberine group and 462 in the placebo group. 155 (36%) participants in the berberine group and 216 (47%) in the placebo group were found to have recurrent adenoma during follow-up (unadjusted relative risk ratio for recurrence 0·77, 95% CI 0·66-0·91; p=0·001). No colorectal cancers were detected during follow-up. The most common adverse event was constipation (six [1%] of 446 patients in the berberine group vs one [<0·5%] of 478 in the placebo group). No serious adverse events were reported. INTERPRETATION: Berberine 0·3 g twice daily was safe and effective in reducing the risk of recurrence of colorectal adenoma and could be an option for chemoprevention after polypectomy. FUNDING: National Natural Science Foundation of China.