BackgroundNone of current diagnostic methods has been proven to be a reliable tool for gastro-esophageal reflux disease (GERD). Pepsin in saliva has been proposed as a promising diagnostic biomarker for gastro-esophageal reflux. We aimed to determine the diagnostic value of salivary pepsin detection for GERD.MethodsTwo hundred and fifty patients with symptoms suggestive of GERD and 35 asymptomatic healthy volunteers provided saliva on morning waking, after lunch and dinner for pepsin determination using the Peptest lateral flow device. All patients underwent 24-h multichannel intraluminal impedance pH (24-h MII-pH) monitoring and upper gastrointestinal endoscopy. Based on 24-h MII-pH and endoscopy study, patients were defined as GERD (abnormal MII-pH results and/or reflux esophagitis) and non-GERD otherwise.ResultsPatients with GERD had a higher prevalence of pepsin in saliva and higher pepsin concentration than patients with non-GERD and healthy controls (P < 0.001 for all). The pepsin test had a sensitivity of 73% and a specificity of 88.3% for diagnosing GERD using the optimal cut-off value of 76 ng/mL. Postprandial saliva samples collected when the symptoms occurred had a more powerful ability to identify GERD.ConclusionsSalivary pepsin test had moderate diagnostic value for GERD. It may be a promising tool to replace the use of currently invasive tools with advantages of non-invasive, easy to perform and cost effective.Trial registration ChiCTR-DDD-16009506 (date of registration: October 20, 2016).
BackgroundLaparoscopic Nissen fundoplication (LNF) is the most common surgical procedure for the surgical management of gastro-esophageal reflux disease (GERD). Laparoscopic Toupet fundoplication (LTF) has been reported to have a lower prevalence of postoperative complications yet still obtain a similar level of reflux control. We conducted a meta-analysis to confirm the value of LNF and LTF.MethodsPubMed, Medline, Embase, Cochrane Library and Springerlink were searched for randomized controlled trials (RCTs) comparing LNF and LTF. Data regarding the benefits and adverse results of two techniques were extracted and compared using a meta-analysis.ResultsEight eligible RCTs comparing LNF (n = 625) and LTF (n = 567) were identified. There were no significant differences between LNF and LTF with regard to hospitalization duration, perioperative complications, patient satisfaction, postoperative heartburn, regurgitation, postoperative DeMeester scores, or esophagites. A shorter operative time and higher postoperative lower esophageal sphincter pressure were associated with LNF. Prevalence of postoperative dysphagia, gas-bloating, inability to belch, dilatation for dysphagia and reoperation were higher after LNF, but subgroup analyses showed that differences with respect to dysphagia between LNF and LTF disappeared over time. Subgroup analyses did not support “tailored therapy” according to preoperative esophageal motility.ConclusionsLNF and LTF have equivalently good control of GERD and result in a similar prevalence of patient satisfaction. Based on current evidence, it is not rational or advisable to abandon LNF when choosing a surgical procedure for GERD.
Background & aims Immunotherapy with hepatitis B virus (HBV)-specific TCR redirected T (HBV-TCR-T) cells in HBV-related hepatocellular carcinoma (HBV-HCC) patients after liver transplantation was reported to be safe and had potential therapeutic efficacy. We aim to investigate the safety of HBV-TCR-T-cell immunotherapy in advanced HBV-HCC patients who had not met the criteria for liver transplantation. Methods We enrolled eight patients with advanced HBV-HCC and adoptively transferred short-lived autologous T cells expressing HBV-specific TCR to perform an open-label, phase 1 dose-escalation study (NCT03899415). The primary endpoint was to evaluate the safety of HBV-TCR-T-cell therapy according to National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03) during the dose-escalation process. The secondary endpoint was to assess the efficacy of HBV-TCR-T-cell therapy by evaluating the anti-tumor responses using RECIST criteria (version 1.1) and the overall survival. Results Adverse events were observed in two participants among the 8 patients enrolled. Only one patient experienced a Grade 3 liver-related adverse event after receiving a dose of 1 × 105 HBV-TCR-T cells/kg, then normalized without interventions with immunosuppressive agents. Among the patients, one achieved a partial response lasting for 27.7 months. Importantly, most of the patients exhibited a reduction or stabilization of circulating HBsAg and HBV DNA levels after HBV-TCR-T-cell infusion, indicating the on-target effects. Conclusions The adoptive transfer of HBV-TCR-T cells into advanced HBV-HCC patients were generally safe and well-tolerated. Observations of clinical efficacy support the continued development and eventual application of this treatment strategy in patients with advanced HBV-related HCC. Clinical trials registration This study was registered at ClinicalTrials.gov (NCT03899415).
Background/AimsTo determine the value of salivary pepsin in discriminating sub-types of gastroesophageal reflux disease (GERD) and GERD-related disorders. MethodsOverall, 322 patients with different sub-types of GERD and 45 healthy controls (HC) were studied. All patients took Gastroesophageal Reflux Disease Questionnaire (GerdQ) and underwent endoscopy and 24-hour esophageal pH monitoring and manometry. Salivary pepsin concentration (SPC) was detected by using colloidal gold double-antibody immunological sandwich assay. Oral esomeprazole treatment was administrated in the patients with non-erosive reflux disease (NERD) and extra-esophageal symptoms (EES). ResultsCompared to HC, patients with erosive esophagitis, NERD, EES, EES plus typical GERD symptoms, or Barrett's esophagus had a higher prevalence of saliva and SPC (all P < 0.001). There was no significant difference in the positive rate for pepsin in patients with functional heartburn or GERD with anxiety and depression, compared to HC. After esomeprazole treatment, the positive rate and SPC were significantly reduced in NERD (both P < 0.001) and in EES (P = 0.001 and P = 0.002, respectively). Of the 64 NERD patients, 71.9% (n = 46) were positive for salivary pepsin, which was significantly higher than the rate (43.8%, n = 28) of pathological acid reflux as detected by 24-hour esophageal pH monitoring (P = 0.002). ConclusionsSalivary pepsin has an important significance for the diagnosis of GERD and GERD-related disorders. Salivary pepsin and 24-hour esophageal pH monitoring may complement with each other to improve the diagnostic efficiency. (J Neurogastroenterol Motil 2020;26:74-84)
Background:Laparoscopic Nissen fundoplication (LNF) has been the gold standard for the surgical management of Gastro-esophageal reflux disease (GERD). Laparoscopic anterior 180° fundoplication (180° LAF) is reported to reduce the incidence of postoperative complications while obtaining similar control of reflux. The present meta-analysis was conducted to confirm the value of the 2 techniques.Methods:PubMed, Medline, Embase, Cochrane Library, Springerlink, and China National Knowledge Infrastructure Platform databases were searched for randomized controlled trials (RCTs) comparing LNF and 180° LAF. Data regarding the benefits and adverse results of 2 techniques were extracted and compared using a meta-analysis.Results:Six eligible RCTs comparing LNF (n = 266) and 180° LAF (n = 265) were identified. There were no significant differences between LNF and 180° LAF with regard to operating time, perioperative complications, length of hospital stay, patient satisfaction, willingness to undergo surgery again, quality of life, postoperative heartburn, proton pump inhibitor (PPI) use, postoperative DeMeester scores, postoperative lower esophageal sphincter (LES) pressure, postoperative gas-bloating, unable to belch, diarrhea, or overall reoperation. LNF was associated with a higher prevalence of postoperative dysphagia compared with 180° LAF, while 180° LAF was followed by more reoperation for recurrent reflux symptoms.Conclusion:LNF and 180° LAF are equally effective in controlling reflux symptoms and obtain a comparable prevalence of patient satisfaction. 180° LAF can reduce the incidence of postoperative dysphagia while this is offset by a higher risk of reoperation for recurrent symptoms. The risk of recurrent symptoms should need to be balanced against the risk of dysphagia when surgeons choose surgical procedures for each individual with GERD.
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