Retrospective analysis of the appendiceal neoplasms: sampling technique may influence neoplasm detection.

BACKGROUND AND AIMS: Appendiceal neoplasms are uncommon entities that are usually determined incidentally during the histopathological examination. Different techniques used for the macroscopic sampling of appendectomy material may affect the determinating neoplasms. MATERIALS AND METHODS: H&E-stained slides of 1280 cases who underwent appendectomy between 2013 and 2018 were reviewed retrospectively for histopathological features. RESULTS: Neoplasms were determined in 28 cases (3.09%); 1 lesion was observed in the proximal part of the appendix, 1 covering the entire length from proximal to distal and 26 in the distal part. In the 26 cases that observed in the distal part, the lesion was seen on both sides of the longitudinal section of the distal appendix in 20 cases, while it was seen on only one distal longitudinal section in the remaining 6 cases. CONCLUSION: The vast majority of appendiceal neoplasms are seen in the distal part of the appendix, and, in some cases, neoplasms might be seen on only one side of the distal section. Sampling only one-half of the distal part of the appendix, where tumours are most often observed, could result in some neoplasms being missed. Therefore, sampling the whole distal part would be more beneficial to determine small diameter tumours that do not create macroscopic findings.

Retrospective analysis of the appendiceal neoplasms: sampling technique may influence neoplasm detection.

BACKGROUND AND AIMS: Appendiceal neoplasms are uncommon entities that are usually determined incidentally during the histopathological examination. Different techniques used for the macroscopic sampling of appendectomy material may affect the determinating neoplasms. MATERIALS AND METHODS: H&E-stained slides of 1280 cases who underwent appendectomy between 2013 and 2018 were reviewed retrospectively for histopathological features. RESULTS: Neoplasms were determined in 28 cases (3.09%); 1 lesion was observed in the proximal part of the appendix, 1 covering the entire length from proximal to distal and 26 in the distal part. In the 26 cases that observed in the distal part, the lesion was seen on both sides of the longitudinal section of the distal appendix in 20 cases, while it was seen on only one distal longitudinal section in the remaining 6 cases. CONCLUSION: The vast majority of appendiceal neoplasms are seen in the distal part of the appendix, and, in some cases, neoplasms might be seen on only one side of the distal section. Sampling only one-half of the distal part of the appendix, where tumours are most often observed, could result in some neoplasms being missed. Therefore, sampling the whole distal part would be more beneficial to determine small diameter tumours that do not create macroscopic findings.

Application of enhanced recovery after surgery (ERAS) protocol in radical gastrectomy: a systemic review and meta-analysis.

PURPOSE: This study aimed to assess the safety and efficiency of the enhanced recovery after surgery (ERAS) protocol in radical gastrectomy. METHODS: Studies published before February 2019 were searched from EMBASE, PubMed, Cochrane Library and Quanfang databases without language and region restrictions. A total of 15 randomised controlled trials (RCTs) with 1216 participants were included in the analysis, of whom 605 underwent ERAS protocol and 611 received traditional perioperative treatment for radical gastrectomy. RESULTS: There was a significant reduction in pulmonary infection (p=0.02) after radical gastrectomy. Further, there was a significant decrease in the length of postoperative hospital days (p<0.00001), first passage time of defection and flatus (p<0.00001), and medical cost (p<0.0001) in the group that received the ERAS protocol. However, the ERAS protocol group had a higher risk for readmission (p=0.007), vomiting (p=0.002) and gastric retention (p=0.0003) compared with the traditional treatment group. CONCLUSIONS: ERAS protocol application for radical gastrectomy accelerated postoperative recovery, shortened postoperative hospital days and first passage time of defection and flatus, and saved on medical costs, and did not increase the occurrence rate of severe complications.

Impact of 'two-week wait' referral pathway on the diagnosis, treatment and survival in upper and lower gastrointestinal cancers.

BACKGROUND: The 'two-week wait'(2WW) referral pathway was introduced in the United Kingdom to reduce waiting times for treatment of cancer. There has been a debate regarding the efficacy of 2WW pathway since its implementation. METHODS: A singleinstitutional analysis of upper gastrointestinal(UGI) and lower gastrointestinal(LGI) malignancies treated between 1April 2015 and 31March 2017 was undertaken to analyse the impact of 2WWreferral pathway on the diagnosis, treatment and survival. RESULTS: 2WW referral does not achieve an earlier diagnosis compared with non-2WW routes of referral in UGI (χ2(3)=2.6, p=0.458) and LGI (χ2(3)=0.884, p=0.829) malignancies. 2WW referral does not lead to an improvement in curative treatment in UGI (OR1.48, 95%CI0.68to3.21, p=0.321) and LGI (OR1.59, 95%CI0.97to2.62, p=0.067) malignancies. No improvement in survival is seen in UGI (HR0.99, 95%CI0.56to1.75, p=0.963) and LGI (HR1.10, 95%CI0.60to1.99, p=0.764) malignancies by virtue of 2WW referral. Emergency presentation is the most common presenting route in UGI malignancy(40%) and is associated with poor survival (HR0.55, 95%CI0.30to0.97, p=0.045).Non-emergency route of presentation is associated with higher rates of curative treatment in UGI malignancies (OR3.49, 95%CI1.57to7.76, p=0.002). Lower rate of curative treatment (OR 0.27, 95%CI0.16to0.43, p<0.001) and poor survival (HR0.44, 95%CI0.26to0.76, p=0.003) is also observed in emergency presentation of LGI malignancy(29%) which is the secondmost common route of presentation in this group. CONCLUSION: 2WW referral does not achieve early diagnosis nor does it lead to an improvement in the rate of curative treatment in UGI and LGI malignancies. No improvement in short-term survival is seen in UGI malignancies nor in LGI malignancies on multivariate analysis by virtue of 2WW referral.

Gastrointestinal manifestations of neuroendocrine tumours: their investigation and management.

The incidence of neuroendocrine tumours (NETs) is on the rise in the UK. Patients with NETs need to be managed by a team of clinical specialties. There are a number of challenging gastrointestinal (GI) manifestations related to NETs that can occur in these patients, but a limited literature base exists to guide clinicians.Whilst life expectancy can be several years for patients with NETs, the GI symptoms can have a significant impact on their quality of life. It is therefore imperative to be familiar with the common GI manifestations associated with NETs, so symptoms can be appropriately managed with an overall aim of restoring the patient's quality of life.

[Significance of microRNA expression in body fluids in the diagnosis of gastrointestinal tumors]. / A testváladékok mikro-RNS-kifejezodésének jelentosége a gyomor-bél rendszeri tumorok diagnosztikájában.

MicroRNAs are small, non-coding, single strained RNAs that regulate gene expression at the posttranscriptional level. They are involved in all major aspects of cellular functions, such as cell cycle, differentiation, migration, apoptosis etc. The role of microRNAs as potential biomarkers of several malignant diseases is being intensively investigated, since they can be found in the body fluids, too, besides their usual intracellular localisation. MicroRNAs have been detected in blood, saliva, stool, breast milk, urine, bile etc. In this review the authors discuss recent findings in the field of microRNAs in stool, bile and saliva, underlying their potential significance in the diagnosis of gastrointestinal tumors.

68Ga-FAPI-04 positron emission tomography/CT and laparoscopy for the diagnosis of occult peritoneal metastasis in newly diagnosed locally advanced gastric cancer: study protocol of a single-centre prospective cohort study.

INTRODUCTION: Accurate baseline clinical staging is critical to inform treatment decision-making for patients with gastric cancers. Peritoneal metastasis (PM) is the most common form of metastasis in gastric cancer and mainly diagnosed by diagnostic laparoscopy and peritoneal lavage evaluation. However, diagnostic laparoscopy is invasive and less cost-effective. It is urgent to develop a safe, fast and non-invasive functional imaging method to verify the peritoneal metastasis of gastric cancer. The aim of our study was to evaluate the proportion of patients in whom 68Ga-FAPI-04 positron emission tomography/CT (PET/CT) led to a change in treatment strategy and to assess the diagnostic accuracy of 68Ga-FAPI-04 PET/CT for the detection of occult peritoneal metastasis compared with laparoscopic exploration. METHODS AND ANALYSIS: In this single-centre, prospective diagnostic test accuracy study, a total of 48 patients with locally advanced gastric or gastro-oesophageal junction adenocarcinoma (cT4a-b, N0-3, M0, based on CT images) who are considering radical tumour surgery will be recruited. All participants will undergo 68Ga-FAPI-04 PET/CT before the initiation of laparoscopic exploration. The primary outcome is the proportion of patients with occult peritoneal metastatic lesions detected by 68Ga-FAPI-04 PET/CT, leading to a change in therapy strategy. The secondary outcomes include the diagnostic performance of 68Ga-FAPI-04 PET/CT for occult peritoneal metastasis, including sensitivity, specificity, accuracy, positive predictive value and negative predictive value. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of West China Hospital, Sichuan University (2022-1484). Study results will be presented at public and scientific conferences and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ChiCTR2300067591.

Neoadjuvant and/or adjuvant chemotherapy for gastric cancer patients with microsatellite instability or deficient mismatch repair: a systematic review and meta-analysis study protocol.

INTRODUCTION: Whether gastric cancer (GC) patients with deficient mismatch repair or microsatellite instability-high (dMMR/MSI-H) benefit from perioperative (neoadjuvant and/or adjuvant) chemotherapy is controversial. This protocol delineates the planned scope and methods for a systematic review and meta-analysis that aims to compare the efficacy of perioperative chemotherapy with surgery alone in resectable dMMR/MSI-H GC patients. METHODS AND ANALYSIS: This study protocol is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols-P guideline. PubMed, Embase, Cochrane (CENTRAL), and the Web of Science databases will be searched, supplemented by a secondary screening of relevant records. Both randomised controlled trials and non-randomised studies will be included in this study. The primary and secondary outcomes under scrutiny will be overall survival, disease-free survival and progression-free survival. Two reviewers will independently screen studies, extract data and assess the risk of bias. We will analyse different treatment settings (eg, neoadjuvant or adjuvant or combined as perioperative chemotherapies) separately and conduct sensitivity analyses. ETHICS AND DISSEMINATION: No ethics approval is required for this systematic review and meta-analysis, as no individual patient data will be collected. The findings of our study will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42023494276.

Fruquintinib plus oxaliplatin combined with S-1 (SOX) as neoadjuvant therapy for locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ): a multicentre, phase II, single-arm, open-label clinical trial (FRUTINEOGA) protocol.

INTRODUCTION: Curing locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ) with surgery alone is challenging. Neoadjuvant chemotherapy (NCT) has become the standard treatment for patients with locally advanced GC/GEJ, and SOX is the most common neoadjuvant regimen in China. The generally good tolerability in patients and fruquintinib's low potential for drug-drug interaction suggest that it may be highly suitable for combinations with other antineoplastic therapies. A combination of fruquintinib, S-1 and oxaliplatin can be a promising neoadjuvant treatment for locally advanced GC/GEJ. In this phase II study, we aim to investigate the efficacy and toxicity of fruquintinib plus SOX as neoadjuvant treatment for locally advanced GC/GEJ. METHODS AND ANALYSIS: The FRUTINEOGA trial is a prospective, multicentre, phase II, single-arm, open-label clinical trial that will enrol 54 patients. Eligible patients will be registered, enrolled and receive 2-4 cycles of fruquintinib plus SOX, after which surgery will be performed and tumour regression will be evaluated. The primary endpoint is the pathological remission rate, and the secondary endpoints are disease-free survival, overall survival, objective response rate, major pathological response rate and R0 resection rate. ETHICS AND DISSEMINATION: Written informed consent will be required from all patients enrolled, and it will be provided by them. The study protocol received approval from the independent ethical review committee of Guangxi Medical University Cancer Hospital, Wuming Hospital of Guangxi Medical University and Wuzhou Red Cross Hospital, Wuzhou Gongren Hospital (approval number: CS2021(96)). We will submit the finalised paper for publication on completing the analyses. This study will provide valuable insights to clinicians regarding the safety and efficacy of incorporating fruquintinib into SOX as neoadjuvant treatment for locally advanced GC/GEJ. The findings have the potential to inform future research proposals and may guide the use of fruquintinib in the neoadjuvant setting for locally advanced GC/GEJ. TRIAL REGISTRATION NUMBER: NCT05122091.

Approaches for the treatment of perforated peptic ulcers: a network meta-analysis of randomised controlled trials - study protocol.

INTRODUCTION: Perforated peptic ulcers are a life-threatening complication associated with high morbidity and mortality. Several treatment approaches are available. The aim of this network meta-analysis (NMA) is to compare surgical and alternative approaches for the treatment of perforated peptic ulcers regarding mortality and other patient-relevant outcomes. METHODS AND ANALYSIS: A systematic literature search of PubMed/MEDLINE, Cochrane Library, Embase, CINAHL, ClinicalTrials.gov trial registry and ICTRP will be conducted with predefined search terms.To address the question of the most effective treatment approach, an NMA will be performed for each of the outcomes mentioned above. A closed network of interventions is expected. The standardised mean difference with its 95% CI will be used as the effect measure for the continuous outcomes, and the ORs with 95% CI will be calculated for the binary outcomes. ETHICS AND DISSEMINATION: In accordance with the nature of the data used in this meta-analysis, which involves aggregate information from previously published studies ethical approval is deemed unnecessary. Results will be disseminated directly to decision-makers (eg, surgeons, gastroenterologists) through publication in peer-reviewed journals and presentation at conferences. PROSPERO REGISTRATION NUMBER: CRD42023482932.

Randomised controlled, patient-blinded, multicentre, superiority trial to evaluate the efficacy of the line-attached sheath-type traction device for endoscopic submucosal dissection in patients with superficial gastric neoplasms.

INTRODUCTION: EndoTrac is a line-attached sheath-type traction device that enables us to control the direction and the force of traction during endoscopic submucosal dissection (ESD). The efficacy of EndoTrac for gastric ESD has not been fully verified. METHODS AND ANALYSIS: The G-Trac study is a multicentre (nine general hospitals and two university hospitals in Japan) collaborative trial assessing the efficacy of EndoTrac for gastric ESDs. Patients with superficial gastric neoplasms will be enrolled and randomly assigned to undergo either conventional ESD or EndoTrac ESD. Allocation will be stratified according to tumour location, operator experience and tumour diameter at an allocation rate of 1:1. The type of endoknife used will be confirmed before randomisation. The primary outcome, procedure time, will be compared between the groups in both intention-to-treat and per-protocol analyses using the Wilcoxon rank sum test. The efficacy-related, safety-related and device-related outcomes will be assessed in the secondary analysis. The planned sample size of the 142 patients in the two groups will enable us to detect a difference with a power of 80% by using the Wilcoxon rank sum test, assuming an effect size of 0.54, asymptotic relative efficiency of 0.864 and a two-sided type 1 error rate of 5%. ETHICS AND DISSEMINATION: This trial was approved by the certified review board of Kobe University (22 December 2022). The results from this trial will be disseminated through peer-review journals, presentations at national and international conferences, and data sharing with other researchers. TRIAL REGISTRATION NUMBER: jRCT1052220166.

Effect of prehabilitation for patients undergoing gastric cancer surgery: a protocol of a systematic review and meta-analysis.

INTRODUCTION: Gastric cancer is a high-risk cancer with surgical treatments often leading to significant postoperative complications and mortality. Prehabilitation, involving exercise, nutrition and psychological support before surgery, aims to boost patients' physical and mental health. While effective in other cancers, its benefits for gastric cancer need further study. This research will evaluate the impact of trimodal prehabilitation on patient outcomes in gastric cancer surgery, aiming to reduce complications and expedite recovery. METHODS AND ANALYSIS: This study will systematically review randomised controlled trials and cohort studies evaluating the role of prehabilitation in people undergoing gastric cancer resection. The primary outcomes of interest will include overall postoperative complications and length of hospital stay. The secondary outcomes of interest will include mortality, readmission rate or functional recovery. Databases including PubMed, EMBASE, CINAHL, CENTRAL, Chinese BioMedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Wanfang database and Chinese Science and Technology Periodicals (VIP) will be searched. All studies will be screened and selected using the criteria described in 'population, intervention/exposure, comparison, outcome and study design' format. Two independent reviewers will screen studies for relevance and methodological validity. Data from included studies will be extracted through a customised, preset data extraction sheet. The Cochrane Review Manager (V.5.3, Nordic Cochrane Centre, Copenhagen, Denmark) software will be used to perform the meta-analysis. ETHICS AND DISSEMINATION: Ethics approval is not required for this study as all results will be based on published papers. No primary data collection will be needed. Study findings will be presented at scientific conferences or published in a peer-reviewed scientific journal. PROSPERO REGISTRATION NUMBER: CRD42023488469.

Investigations and referral for suspected gastric cancer by primary care physicians: a cross-sectional study in Southeastern China.

BACKGROUND: Early recognition and accurate diagnosis are particularly important in the context of gastric cancer. This study mainly aimed to investigate primary care physicians' (PCPs') clinical behaviour and their readiness to consider investigation or referral for symptoms possibly indicative of gastric cancer. DESIGN: Cross-sectional study. SETTING: A self-administered online survey was carried out in five selected cities in the Fujian province of China between February 2022 and May 2022. PARTICIPANT: PCPs working in the departments, such as Internal Gastroenterology and Hepatology, General Internal Medicine, Internal Medical Oncology Gastrointestinal Surgery or other clinical departments, have the chance to diagnose or treat patients with suspected gastric cancer. MAIN OUTCOME MEASURES: Percentage of PCPs identifying gastric cancer patients either by undertaking an endoscopy at the primary hospital or by referring patients to an upper-level hospital. RESULTS: A total of 1210 complete responses were received. Nearly half of responding PCPs (46.4%) only had less than 5 years of clinical experience, and the majority worked in suburban or rural regions (64.4%). Direct access to blood tests for cancer diagnosis (77.9%), X-ray (77.2%), CT (55.7%), ultrasound (85.3%), upper gastrointestinal endoscopy (54.4%) and colonoscopy (51.9%) was common. Of the respondents, 85.5% reported that they could get specialist advice for a suspected cancer patient within 48 hours in terms of investigations and 84.0% in terms of referral. Patients' waiting time to either conduct a test or have a result was mostly less than 1 week. In patients indicative of gastric cancer, a total of 1148 (94.8%) physicians were ready to investigate cancer either by sending patients to an endoscopy test (49.7%) or referring them to an upper-level hospital (45.1%). CONCLUSIONS: Findings indicate that PCPs in five selected cities of Southeastern China have wide and rapid access to diagnostic tests and specialist advice. Furthermore, PCPs in this region seem to have a high level of readiness to consider investigation or referral for symptoms possibly indicative of gastric cancer.

Association between prophylactic closure of mucosal defect and delayed adverse events after endoscopic resection: a systematic review and meta-analysis.

OBJECTIVE: To investigate the potential of prophylactic closure of mucosal defects to prevent adverse events following endoscopic resection of superficial layers of the gastrointestinal (GI) wall. DESIGN: Systematic review and meta-analysis. DATA SOURCES: We searched PubMed, Embase, Web of Science and the Cochrane Library for studies eligible for inclusion in our meta-analysis from inception to February 2022. DATA EXTRACTION AND SYNTHESIS: We compared the effects of closure versus non-closure of mucosal defects with respect to adverse events including delayed bleeding, delayed perforation and postpolypectomy coagulation syndrome (PPCS). We used a random-effects model for all analyses. Subgroup analyses were performed based on gastrointestinal sites, surgical procedures and study designs. RESULTS: In total, this study includes 11 383 patients from 28 studies. For delayed bleeding, closure group was associated with a lower incidence (Risk Ratio [RR]: 0.40, 95% Confidence interval [CI]: 0.30 to 0.53, p<0.001; I2=25%) and consistent results were observed in the subgroups. Also, for delayed perforation, a combined analysis of all sites and surgical methods showed a protective effect of prophylactic closure of mucosal defects (RR: 0.42, 95% CI: 0.22 to 0.82, p=0.01; I2=0%). Similar results were observed in the subgroup analyses, despite the wide CIs. Regarding the PPCS, neither the pooled RRs nor the subgroup analyses showed significant differences. CONCLUSION: Prophylactic closure of mucosal defects is beneficial in reducing the incidence of delayed bleeding and delayed perforation after endoscopic resection, but there is no significant difference in reducing the incidence of PPCS.

Effectiveness of peritoneal lavage fluid circulating tumour cells and circulating tumour DNA in the prediction of metachronous peritoneal metastasis of gastric cancer (pT4NxM0/pT1-3N+M0) after radical resection: protocol of a prospective single-centre clinical study.

BACKGROUND: Gastric cancer (GC) is the fourth leading cause of cancer mortality worldwide. Peritoneal metastasis (PM) is a significant cause of death in patients with GC, and presents a major challenge in clinical diagnosis and treatment. Predicting the occurrence of PM in high-risk patients, and diagnosing and treating PM in advance to improve patient survival, remains an unsolved problem in clinical practice. Given the low positive rate of cytology and difficulty in diagnosing occult PM, new molecular markers and detection technologies for early diagnosis require urgent validation. The primary objective of this study is to observe and evaluate the predictive effect of intraoperative peritoneal lavage fluid (PLF) circulating tumour cells (CTC) and circulating tumour DNA (ctDNA) levels in patients with pT4NxM0/pT1-3N+M0 GC on metachronous PM after R0 resection. METHODS AND ANALYSIS: This prospective single-centre clinical study is conducted at Renji Hospital, Shanghai Jiao Tong University School of Medicine. In this study, 200 cases of patients with pT4NxM0/pT1-3N+M0 gastric adenocarcinoma older than 18 years will be screened. Participants will undergo intraoperative PLF CTC and ctDNA testing and will be followed up for 2 years, with imaging assessments performed every 3-6 months until PM occurrs. The primary outcome is the incidence of PM 1 year after surgery, which will be estimated using Clopper-Pearson method, with 95% CIs calculated and compared between groups. Secondary outcome include the incidence of PM 2 years after surgery, overall survival and disease progression. Data will be analysed using the Kaplan-Meier method and the log-rank test. ETHICS AND COMMUNICATION: Informed consent has been obtained from all subjects. This protocol has been approved by the Ethics Committee of Renji Hospital, Shanghai Jiao Tong University School of Medicine (LY2023-142-B). The findings will be disseminated through peer-reviewed manuscripts, reports and presentations. TRIAL REGISTRATION NUMBER: ChiCTR2300074910.

Perfusion outcomes with near-infrared indocyanine green imaging system in laparoscopic total mesorectal excision for mid-rectal or low-rectal cancer (POSTER): a study protocol.

INTRODUCTION: Anastomotic leakage (AL) is defined as the failure of complete healing or disruption of the anastomosis subsequent to rectal cancer surgery, resulting in the extravasation of intestinal contents into the intra-abdominal or pelvic cavity. It is a serious complication of rectal cancer surgery, accounting for a considerable increase in morbidity and mortality. The use of fluorescence imaging technology in surgery allows surgeons to better evaluate blood perfusion. However, the conclusions of some existing studies are not consistent, so a consensus on whether the near-infrared indocyanine green (NIR-ICG) imaging system can reduce the incidence of AL is needed. METHODS: This POSTER trial is designed as a multicentre, prospective, randomised controlled clinical study adhering to the "population, interventions, comparisons, outcomes (PICO)" principles. It is scheduled to take place from August 2019 to December 2024 across eight esteemed hospitals in China. The target population consists of patients diagnosed with rectal cancer through pathological confirmation, with tumours located≤10 cm from the anal verge, eligible for laparoscopic surgery. Enrolled patients will be randomly assigned to either the intervention group or the control group. The intervention group will receive intravenous injections of ICG twice, with intraoperative assessment of anastomotic blood flow using the near-infrared NIR-ICG system during total mesorectal excision (TME) surgery. Conversely, the control group will undergo conventional TME surgery without the use of the NIR-ICG system. A 30-day follow-up period postoperation will be conducted to monitor and evaluate occurrences of AL. The primary endpoint of this study is the incidence of AL within 30 days postsurgery in both groups. The primary outcome investigators will be blinded to the application of ICG angiography. Based on prior literature, we hypothesise an AL rate of 10.3% in the control group and 3% in the experimental group for this study. With a planned ratio of 2:1 between the number of cases in the experimental and control groups, and an expected 20% lost-to-follow-up rate, the initial estimated sample size for this study is 712, comprising 474 in the experimental group and 238 in the control group. ETHICS AND DISSEMINATION: This study has been approved by Ethics committee of Beijing Friendship Hospital, Capital Medical University (approval number: 2019-P2-055-02). The results will be disseminated in major international conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04012645.

Grading carcinoembryonic antigen levels can enhance the effectiveness of prognostic stratification in patients with colorectal cancer: a single-centre retrospective study.

OBJECTIVES: This study developed a refined carcinoembryonic antigen (CEA) grading system using CEA cut-off points of 5, 20 and 50 ng/mL and to explore the prognostic value of CEA grading in predicting the progression-free survival (PFS) and overall survival (OS) of colorectal cancer (CRC) patients. DESIGN: A retrospective cohort study. SETTING: First Affiliated Hospital of Guangxi Medical University. PARTICIPANTS: 1107 CRC patients who received surgical treatment. MATERIALS AND METHODS: Survival analysis was conducted using the Kaplan-Meier method and compared using the log-rank test. A Cox regression model with a 95% CI was used to evaluate the independent prognostic risk factors for CRC. Prognostic nomograms were constructed to predict the 1-5-year PFS/OS. RESULTS: Elevated serum CEA levels are often indicative of recurrence and death in CRC patients. Higher CEA levels were significantly associated with more aggressive tumour phenotypes. The CEA grading system was an independent predictor of prognosis in CRC patients and effectively stratified PFS (62.0% vs 51.2% vs 33.7% vs 20.2%, p<0.001) and OS (64.7% vs 54.4% vs 36.6% vs 22.5%, p<0.001) in CRC patients. As the CEA grade increased, the risk of poor prognosis gradually increased in a gradient manner, with an approximately 10% difference in risk grade between each CEA grade. The internal validation cohort further confirmed that CEA grade remains an effective prognostic factor for the survival of CRC patients. Prognostic nomograms, which integrate individual characteristics, tumour features and CEA grading, provide a more comprehensive prognostic evaluation for CRC patients. CONCLUSIONS: The CEA grading system is an independent predictor of prognosis for CRC patients and can effectively stratify PFS and OS.