BACKGROUND: Patients with clinically significant portal hypertension (CSPH) are recommended to be treated with non-selective beta-blockers (ie, carvedilol) to prevent the first hepatic decompensation event by the renewing Baveno VII consensus. CSPH is defined by hepatic venous pressure gradient (HVPG)≥10 mm Hg; however, the HVPG measurement is not widely adopted due to its invasiveness. Liver stiffness (LS)≥25 kPa can be used as a surrogate of HVPG≥10 mm Hg to rule in CSPH with 90% of the positive predicting value in majority aetiologies of patients. A compelling argument is existing for using LS≥25 kPa to diagnose CSPH and then to initiate carvedilol in patients with compensated cirrhosis, and about 5%-6% of patients under this diagnosis criteria may not be benefited from carvedilol and are at risk of lower heart rate and mean arterial pressure. Randomised controlled trial on the use of carvedilol to prevent liver decompensation in CSPH diagnosed by LS remains to elucidate. Therefore, we aimed to investigate if compensated cirrhosis patients with LS≥25 kPa may benefit from carvedilol therapy.
METHODS: This study is a randomised, double-blind, placebo-controlled, multicentre trial. We will randomly assign 446 adult compensated cirrhosis patients with LS≥25 kPa and without any previous decompensated event and without high-risk gastro-oesophageal varices. Patients are randomly divided into two groups, with 223 subjects in group A and 223 subjects in group B. Group A is a carvedilol intervention group, while group B is a placebo group. All patients in both groups will receive aetiology therapies and are followed up at an interval of 6 months. The 3-year incidences of decompensated events of cirrhosis-related and liver-related death are the primary outcome. The secondary outcomes include development of each complication of portal hypertension individually (ascites, variceal bleeding or overt hepatic encephalopathy), development of spontaneous bacterial peritonitis and other bacterial infections, development of new varices, growth of small varices to large varices, delta changes in LS and spleen stiffness, change in hepatic dysfunction assessed by Child-Pugh and model for end-stage liver disease score, change in platelet count, development of hepatocellular carcinoma, development of portal vein thrombosis and adverse events with a 3-year follow-up. A predefined interim analysis will be performed to ensure that the calculation is reasonable.
BACKGROUND: The study protocol has been approved by the ethics committees of the Sixth People\'s Hospital of Shenyang (2023-05-003-01) and independent ethics committee for clinical research of Zhongda Hospital, affiliated to Southeast University (2023ZDSYLL433-P01). The results from this trial will be submitted for publication in peer-reviewed journals and will be presented at international conferences.
BACKGROUND: ChiCTR2300073864.

OBJECTIVE: To compare the efficacy and safety of seven Chinese patent medicines (CPMs) combined with conventional triple/quadruple therapy (T/Q) for Helicobacter pylori-positive peptic ulcers.
METHODS: A systematic review and network meta-analysis.
METHODS: China National Knowledge Infrastructure, VIP database, Wanfang database, ScienceDirect, EBSCO, EMBASE, Web of Science, Cochrane Library and PubMed were searched through 1 June 2022.
METHODS: Randomised controlled trials (RCTs) testing CPMs combined with T/Q for H. pylori-positive peptic ulcers were included. The CPMs included Anweiyang capsule, Jianweiyuyang tablets/capsule/granule, Jinghuaweikang capsule, Kangfuxin liquid, Puyuanhewei capsule, Weifuchun tablets/capsule and Weisu granule. At least one of the following outcome indicators was recorded: complete ulcer healing rate (CUHR), effective rate (ER), H. pylori eradication rate (HPER), rate of peptic ulcer recurrence (RPUR) and incidence of adverse reactions (IAR).
METHODS: Two researchers independently conducted the study selection and extracted data for included studies. The risk of bias was assessed using the Cochrane risk of bias tool. A pairwise meta-analysis was performed using RevMan V.5.3. Network meta-analysis was performed using STATA/MP V.15.0. Confidence in the evidence was assessed using Grading of Recommendations, Assessment, Development and Evaluation.
RESULTS: A total of 36 RCTs involving 3620 patients were included. Compared with T/Q alone, Weisu+T/Q, Weifuchun+T/Q and Puyuanhewei+T/Q had the highest CUHR, ER and HPER, respectively. Weisu+T/Q and Jianweiyuyang+T/Q had the lowest RPUR and IAR, respectively. The cluster analysis results showed Jianweiyuyang+T/Q might be the best choice concerning efficacy and safety simultaneously, followed by Kangfuxin+T/Q.
CONCLUSIONS: Among the combination therapies with the CPMs, Jianweiyuyang+T/Q might be the most favourable option for H. pylori-positive peptic ulcers, followed by Kangfuxin+T/Q. Considering the limited quantity and quality of the included RCTs, the results should be interpreted with caution.
UNASSIGNED: CRD42022327687.

OBJECTIVE: To describe the severity and impact of gastrointestinal involvement in patients with systemic sclerosis (SSc) and identify associated factors.
METHODS: Non-controlled cross-sectional study of patients with SSc (2013 American College of Rheumatology/European League Against Rheumatism criteria). The main variables were severity of gastrointestinal involvement according to the University of California, Los Angeles Scleroderma Clinical Trials Consortium Gastrointestinal Tract 2.0 instrument (UCLA SCTC GIT 2.0) and dysphagia according to the Eating Assessment Tool-10 (EAT-10). We evaluated reflux, distension, diarrhoea, faecal soilage, constipation, emotional well-being and social functioning, as well as dysphagia. Clinical and epidemiological data were collected using the Mini Nutritional Assessment Short Form (MNA-SF) and the EuroQol-5D-3L. The degree of skin fibrosis was assessed using the modified Rodnan skin score (mRSS). Multivariate models were constructed to analyse factors associated with gastrointestinal involvement and dysphagia.
RESULTS: Of the 75 patients with SSc included, 58.7% had moderate, severe or very severe reflux, 57.4% had constipation according to UCLA SCTC GIT 2.0 and 49.7% had abdominal distension. Gastrointestinal symptoms interfered significantly with social functioning (42.7%) and emotional well-being (40.0%). Dysphagia (EAT-10≥3) was recorded in 52% of patients, and according to MNA-SF poor nutrition in 30.7%, and clear malnutrition requiring a nutritional intervention in 5.3%. Multivariate adjustment revealed an association between severity of gastrointestinal symptoms according to the mRSS (β=0.249; p=0.002) and Visual Analogue Scale 3-Level EuroQol-5D (VAS-EQ-5D-3L) (β=-0.302; p=0.001), whereas presence of dysphagia was associated with the mRSS (OR=2.794; p=0.015), VAS-EQ-5D-3L (OR=0.950; p=0.005) and malnutrition (MNA-SF≤7; OR=3.920; p=0.041).
CONCLUSIONS: Patients with SSc frequently present severe gastrointestinal symptoms. These are associated with poor quality of life, more severe skin involvement and malnutrition.

OBJECTIVE: This study aimed to assess the internal law and time trend of hospitalisation for oesophagogastric variceal bleeding (EGVB) in cirrhosis and develop an effective model to predict the trend of hospitalisation time.
METHODS: We used a time series covering 72 months to analyse the hospitalisation for EGVB in cirrhosis. The number of inpatients in the first 60 months was used as the training set to establish the autoregressive integrated moving average (ARIMA) model, and the number over the next 12 months was used as the test set to predict and observe their fitting effect.
UNASSIGNED: Case data of patients with EGVB between January 2014 and December 2019 were collected from the Affiliated Hospital of Southwest Medical University.
METHODS: The number of monthly hospitalised patients with EGVB in our hospital.
RESULTS: A total of 877 patients were included in the analysis. The proportion of EGVB in patients with cirrhosis was 73% among men and 27% among women. The peak age at hospitalisation was 40-60 years. The incidence of EGVB varied seasonally with two peaks from January to February and October to November, while the lowest number was observed between April and August. Time-series analysis showed that the number of inpatients with EGVB in our hospital increased annually. The sequence after the first-order difference was a stationary series (augmented Dickey-Fuller test p=0.02). ARIMA (0,1,0) (0,1,1)12 with a minimum Akaike Information Criterion value of 260.18 could fit the time trend of EGVB inpatients and had a good short-term prediction effect. The root mean square error and mean absolute error were 2.4347 and 1.9017, respectively.
CONCLUSIONS: The number of hospitalised patients with EGVB at our hospital is increasing annually, with seasonal changes. The ARIMA model has a good prediction effect on the number of hospitalised patients with EGVB in cirrhosis.

The Re-Evaluating the Inhibition of Stress Erosions (REVISE) Trial aims to determine the impact of the proton pump inhibitor pantoprazole compared with placebo on clinically important upper gastrointestinal (GI) bleeding in the intensive care unit (ICU), 90-day mortality and other endpoints in critically ill adults. The objective of this report is to describe the rationale, methodology, ethics and management of REVISE.
REVISE is an international, randomised, concealed, stratified, blinded parallel-group individual patient trial being conducted in ICUs in Canada, Australia, Saudi Arabia, UK, US, Kuwait, Pakistan and Brazil. Patients≥18 years old expected to remain invasively mechanically ventilated beyond the calendar day after enrolment are being randomised to either 40 mg pantoprazole intravenously or an identical placebo daily while mechanically ventilated in the ICU. The primary efficacy outcome is clinically important upper GI bleeding within 90 days of randomisation. The primary safety outcome is 90-day all-cause mortality. Secondary outcomes include rates of ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine level in the ICU, and duration of mechanical ventilation, ICU and hospital stay. The sample size is 4800 patients; one interim analysis was conducted after 2400 patients had complete 90-day follow-up; the Data Monitoring Committee recommended continuing the trial.
All participating centres receive research ethics approval before initiation by hospital, region or country, including, but not limited to - Australia: Northern Sydney Local Health District Human Research Ethics Committee and Mater Misericordiae Ltd Human Research Ethics Committee; Brazil: Comissão Nacional de Ética em Pesquisa; Canada: Hamilton Integrated Research Ethics Board; Kuwait: Ministry of Health Standing Committee for Coordination of Health and Medical Research; Pakistan: Maroof Institutional Review Board; Saudi Arabia: Ministry of National Guard Health Affairs Institutional Review Board: United Kingdom: Hampshire B Research Ethics Committee; United States: Institutional Review Board of the Nebraska Medical Centre. The results of this trial will inform clinical practice and guidelines worldwide.
NCT03374800.

The lifestyle and habit changes that have emerged as a result of quarantine measures may have had a negative impact on defecation habits. However, there is a lack of data on combined estimates of its occurrence and prevalence.
We will conduct a systematic search for observational studies on PubMed/MEDLINE, Web of Science, Cochrane Library, EMBASE, CNKI, SinoMed, VIP China Science and Technology Journal database, Chinese Biomedical Databases and Wanfang Data. The search will include literature published from the inception of the databases to September 2022. Two authors will independently screen articles and extract data based on predefined inclusion and exclusion criteria. The risk of bias in the included studies will be evaluated using the Newcastle-Ottawa Scale for observational studies. Statistical analysis will be performed using Review Manager software V.5.4 and STATA V.16.0 software. Heterogeneity among studies will be assessed using the Q statistical test and I2 statistical tests. In case of significant heterogeneity, subgroup analysis and sensitivity analysis will be conducted to explore the source of heterogeneity. Sensitivity analyses will also be performed to assess the reliability of the study findings. If feasible, a meta-analysis will be conducted. Otherwise, a descriptive synthesis will be performed using a best-evidence synthesis approach. The primary outcome of interest will be the prevalence of constipation. The secondary outcomes will involve examining the association of risk factors. To evaluate potential publication bias, we will use both the Begg funnel plot and Egger\'s weighted regression statistics. Furthermore, to accurately assess the quality of evidence for our primary outcome, we will employ the Grading of Recommendations Assessment, Development and Evaluation system.
This systematic review protocol will only consider published studies available in databases and will not include individual patient data. Therefore, ethical approval is not required, and the findings will be published in a peer-reviewed journal.
CRD42022366176.

Benign gastric outlet obstruction (BGOO) severely impacts the quality of life of patients. The main treatment methods for BGOO include surgery and endoscopy, but both have significant drawbacks. Therefore, this study aims to explore the safety and efficacy of a new technique, to develop a new option for treating BGOO.
This is an ongoing prospective, single-centre, single-blind randomised controlled trial. The study will be conducted from January 2022 to December 2025, and 50 patients will be enrolled. The participants will be randomly assigned in a 1:1 ratio to either the experimental (stomach-partitioning gastrojejunostomy with distal selective vagotomy) or control groups (conventional gastrojejunostomy with highly selective vagotomy). We will collect baseline characteristics, laboratory tests, auxiliary examinations, operation, postoperative conditions and follow-up data. Follow-up will last for 3 years. The main outcome is the incidence of delayed gastric emptying within 30 days after surgery. Secondary outcomes include the efficacy indicator (consisting of serum gastrin level, pepsinogen level, 13C breath test, gastrointestinal quality of life index, operation time, blood loss and postoperative recovery), a safety evaluation index (consisting of complications and mortality within 30 days after surgery) and follow-up data (consisting of the incidence of primary ulcer progression in 3 years after surgery, and the gastroscopy results in 1 and 3 years after surgery).
This study was approved by the Ethics Committee of Beijing Friendship Hospital, Capital Medical University (no. 2021-P2-274-02). The study conformed to the provisions of the Declaration of Helsinki (as revised in 2013). Written informed consent will be obtained prior to study enrolment. The results of this study will be published in peer-reviewed publications.
ChiCTR2100052197.

Postoperative nausea and vomiting (PONV) is a distressing symptom that patients often complain of even after less invasive surgery such as laparoscopic surgery (LS). If PONV is not well managed, patient recovery and postoperative quality of life are adversely affected. Although various drugs have been administered to prevent PONV, their effectiveness is limited, and adverse effects are numerous. Although herbal medicines have been widely used to manage various gastrointestinal symptoms, including nausea and vomiting, scientific evidence of their effects is lacking. This protocol is intended for a systematic review to analyse the efficacy and safety of Chinese herbal medicines for PONV after LS through a meta-analysis.
Randomised controlled trials, reported until June 2022, will be retrieved from electronic databases such as Medline, EMBASE and Cochrane Library. We will compare the effects of herbal medicine in patients presenting with PONV after LS with those of Western medicine, placebo and no treatment. If sufficient studies are identified, we will evaluate the combined effects of herbal and Western medicine. The incidence of nausea and vomiting will be considered the primary outcome. Secondary outcomes will include the intensity of complaints, quality of life and incidence of adverse events. Two independent reviewers will collect data based on the Preferred Reporting Items for Systematic Review and Meta-Analyses statement, evaluate the quality of each study using the Cochrane risk-of-bias tool and synthesise the results via meta-analysis, if possible.
Ethical approval is not required for this review. The results of this study will be disseminated to peer-reviewed journals and posters.
CRD42022345749.

Acute upper gastrointestinal bleeding (UGIB) is a common reason for emergency hospital admission. Identifying low-risk patients suitable for outpatient management is a clinical and research priority. This study aimed to develop a simple risk score to identify elderly patients with UGIB for whom hospital admission is not required.
This was a single-centre retrospective study.
This study was conducted at Zhongda Hospital affiliated with Southeast University in China.
Patients from January 2015 to December 2020 for the derivation cohort and from January 2021 to June 2022 for the validation cohort were enrolled in this study. A total of 822 patients (derivation cohort=606 and validation cohorts=216) were included in this study. Patients aged ≥65 years with coffee-grounds vomiting, melena or/and haematemesis were included in the analysis. Patients admitted but had UGIB or transferred between hospitals were excluded.
Baseline demographic characteristics and clinical parameters were recorded at the first visit. Data were collected from electronic records and databases. Multivariable logistic regression modelling was performed to identify predictors of safe discharge.
304/606 (50.2%) and 132/216 (61.1%) patients were not safely discharged in the derivation and validation cohorts, respectively. A clinical risk score of five variables was entered into UGIB risk stratification: Charlson Comorbidity Index >2, systolic blood pressure <100 mm Hg, haemoglobin <100 g/L, blood urea nitrogen ≥6.5 mmol/L, albumin <30 g/L. The optimal cut-off value was ≥1, the sensitivity was 97.37% and the specificity was 19.21% for predicting the inability to discharge safely. The area under the receiver operating characteristic curve was 0.806.
A novel clinical risk score with good discriminative performance was developed to identify elderly patients with UGIB who were suitable for safe outpatient management. This score can reduce unnecessary hospitalisations.

UNASSIGNED: At present, the relationship between virulence factors of Helicobacter pylori (H. pylori) and gastrointestinal diseases is still under discussion. This study investigated the association between distinct virulence factors in H. pylori and different gastrointestinal diseases.
UNASSIGNED: Gastric biopsy specimens were obtained from 160 patients with different gastrointestinal diseases in China, including 77 patients with chronic gastritis (CG), 36 with peptic ulcer disease (PUD), and 38 with gastric carcinoma (GC). The presence of certain virulence genes was determined by polymerase chain reaction (PCR), and the results were analyzed using chi-squared tests.
UNASSIGNED: A total of 160 H. pylori strains were successfully isolated from gastric biopsy specimens. Overall, all strains of H. pylori were cagA, cagE positive, and the most common vacA genotypes were s1 (98.8%) and m2 (68.1%). The positive rates of the jhp0562, jhp0563, homA, homB, hopQI, and hopQII genes were 99.4%, 32.5%, 33.1%, 71.3%, 100%, and 6.9%, respectively. There was no significant association between these genes and different disease types. The dominant hpyIIIR-positive genotype was detected in 83.1% of the strains, making it significantly more prevalent than the hrgA-positive genotype (P<0.001). Surprisingly, the mixed genotype of hrgA and hpyIIIR was common and accounted for 41.3%. The hrgA-positive strains were more common in GC patients (71.1%) compared to CG patients (50.7%, P<0.05). The mixed genotype was prevalent and accounted for 55.3% and 31.2% of strains from GC and CG patients, respectively. Multivariate analysis showed that the hrgA gene exhibited a positive correlation with GC and increased the risk of GC [odds ratio (OR) =3.606, P<0.05]. In contrast, the presence of hrgA exhibited a negative correlation with CG (OR =0.499, P<0.05).
UNASSIGNED: These results suggested that the universal presence of cagA, cagE, vacA s1, jhp0562, homB, and hopQI made it impossible to examine disease-specific associations with any of these virulence factors. In addition, they may synergistically contribute to more virulent strains and severe diseases in China. Furthermore, there was a strong association between the hrgA gene and progression to GC, indicating the potential application of other virulence factors in clinical detection.