Administration of oral prednisolone to prevent esophageal stricture after balloon-type radiofrequency ablation for ultralong-segment esophageal neoplasia.

BACKGROUND AND AIMS: Endoscopic radiofrequency ablation (RFA) has shown good efficacy and safety in eradicating flat-type early esophageal squamous cell neoplasia (ESCN). However, post-RFA stricture is still a major concern, especially when treating ultralong-segment ESCNs. The aim of this study was to investigate the efficacy and safety of oral prednisolone to prevent post-RFA stricture. METHODS: We prospectively enrolled 48 patients treated with balloon-type RFA who had Lugol-unstained or mosaic-like flat-type ESCNs with an expected treatment area more than 10 cm. Oral prednisolone was started at a dose of 30 mg/day on the third day after RFA and continued for 4 weeks. The results were compared to a historical control group of 25 patients who received RFA without oral steroids. The primary endpoint was the frequency of post-RFA stricture. Secondary endpoints were the number of balloon dilation sessions and adverse event rate. RESULTS: There were no significant differences in the worst pathology grade at baseline, length of unstained lesions between the two groups. The complete response rates after 1 session of RFA were 73% and 72%, respectively. Compared to the control group, the oral prednisolone group had a significantly lower stricture rate (4%, 2/48 patients vs. 44%, 11/25 patients; P<0.0001) and a lower number of balloon dilation sessions (median 0, range 0-4 vs. median 6, range 0-10). There were two cases of asymptomatic candida esophagitis in the study group, and no severe adverse effects. CONCLUSIONS: Oral prednisolone may offer a useful and safe preventive option for post-RFA stricture in ultralong ESCNs. CLINICAL TRIAL REGISTRATION NUMBER: NCT05768282.

Prognostic Impact of Diabetes Mellitus on Overall Survival in a Nationwide Population-Based Cohort of Patients With Pancreatic Cancer.

OBJECTIVE: Diabetes mellitus (DM) is a risk factor for pancreatic cancer but its prognostic impact remains controversial. We aimed to investigate the association between long-standing DM and the risk of mortality. METHODS: This population-based cohort study analyzed data from the national healthcare database in Taiwan. We identified all patients diagnosed with pancreatic cancer and excluded those who were diagnosed with DM with-in 2 years of the cancer diagnosis. Eligible patients were grouped into long-standing DM (>2 years) and nondiabetic controls, and were compared for overall survival using a Cox proportional hazard model. Sensitivity tests stratified by cancer stages (as indicated by specific treatment) were performed. RESULTS: Patients with long-standing DM were significantly older (mean age, 71.38 years versus 66.0 years; P<.0001) and had a higher Charlson comorbidity index (9.53 versus 6.78; P<.0001) and diabetes comorbidity severity index (2.38 versus 0.82; P<.0001) compared with the non-DM controls. Although the unadjusted analysis showed a higher risk of mortality in the patients with long-term DM (crude hazard ratio [HR], 1.26; 95% confidence interval [CI], 1.20 to 1.33; P<.0001), the association became insignificant after adjustment for age, sex, and comorbidity index (adjusted HR, 1.01; 95% CI, 0.95 to 1.06, P = .84). Subgroup analyses also showed no association between long-term DM and mortality in various subgroups stratified by cancer treatment. CONCLUSION: After adjusting for associated comorbidities and complications, long-standing DM per se was not an independent prognostic factor for overall survival in this nationwide population-based cohort with pancreatic cancer. ABBREVIATIONS: CCI = Charlson Comorbidity Index; CI = confidence interval; DCSI = Diabetes Complication Severity Index; DM = diabetes mellitus; HR = hazard ratio; ICD = International Classification of Diseases; NHIRD = National Health Insurance Research Database; RCIPD = Registry for Catastrophic Illness Patient Database.

Hepatitis B core-related antigen dynamics and risk of subsequent clinical relapses after nucleos(t)ide analog cessation.

BACKGROUND/AIMS: Finite nucleos(t)ide analog (NA) therapy has been proposed as an alternative treatment strategy for chronic hepatitis B (CHB), but biomarkers for post-treatment monitoring are limited. We investigated whether measuring hepatitis B core-related antigen (HBcrAg) after NA cessation may stratify the risk of subsequent clinical relapse (CR). METHODS: This retrospective multicenter analysis enrolled adults with CHB who were prospectively monitored after discontinuing entecavir or tenofovir with negative HBeAg and undetectable HBV DNA at the end of treatment (EOT). Patients with cirrhosis or malignancy were excluded. CR was defined as serum alanine aminotransferase > two times the upper limit of normal with recurrent viremia. We applied time-dependent Cox proportional hazard models to clarify the association between HBcrAg levels and subsequent CR. RESULTS: The cohort included 203 patients (median age, 49.8 years; 76.8% male; 60.6% entecavir) who had been treated for a median of 36.9 months (interquartile range [IQR], 36.5-40.1). During a median post-treatment follow-up of 31.7 months (IQR, 16.7-67.1), CR occurred in 104 patients with a 5-year cumulative incidence of 54.8% (95% confidence interval [CI], 47.1-62.4%). Time-varying HBcrAg level was a significant risk factor for subsequent CR (adjusted hazard ratio [aHR], 1.53 per log U/mL; 95% CI, 1.12-2.08) with adjustment for EOT HBsAg, EOT anti-HBe, EOT HBcrAg and time-varying HBsAg. During follow-up, HBcrAg <1,000 U/mL predicted a lower risk of CR (aHR, 0.41; 95% CI, 0.21-0.81). CONCLUSION: Dynamic measurement of HBcrAg after NA cessation is predictive of subsequent CR and may be useful to guide post-treatment monitoring.

Medium-term surgical outcomes and health-related quality of life after laparoscopic vs open colorectal cancer resection: SF-36 health survey questionnaire.

BACKGROUND: Previous studies that compared the postoperative health-related quality of life (HRQoL) outcomes after receiving laparoscopic resection (LR) or open resection (OR) in patients with colorectal cancer (CRC) have different conclusions. AIM: To explore the medium-term effect of postoperative HRQoL in such patients. METHODS: This study randomized 567 patients undergoing non-metastatic CRC surgery managed by one surgeon to the LR or OR groups. HRQoL was assessed during the preoperative period and 3, 6, and 12 mo postoperative using a modified version of the 36-Item Short Form (SF-36) Health Survey questionnaire, emphasizing eight specific items. RESULTS: This cohort randomly assigned 541 patients to receive LR (n = 296) or OR (n = 245) surgical procedures. More episodes of postoperative urinary tract infection (P < 0.001), wound infection (P < 0.001), and pneumonia (P = 0.048) were encountered in the OR group. The results demonstrated that the LR group subjectively gained mildly better general health (P = 0.045), moderately better physical activity (P = 0.006), and significantly better social function recovery (P = 0.0001) 3 mo postoperatively. Only the aspect of social function recovery was claimed at 6 mo, with a significant advantage in the LR group (P = 0.001). No clinical difference was found in HRQoL during the 12 mo. CONCLUSION: Our results demonstrated that LR resulted in better outcomes, including intra-operative blood loss, surgery-related complications, course of recovery, and especially some health domains of HRQoL at least within 6 mo postoperatively. Patients should undergo LR if there is no contraindication.

Factors Associated with Increased Severity of Erosive Esophagitis 1 Year After Laparoscopic Sleeve Gastrectomy.

PURPOSE: Weight reduction decreases gastroesophageal reflux disease (GERD), but laparoscopic sleeve gastrectomy (LSG) that damages the structure of the stomach may worsen GERD. We aimed to elucidate the factors associated with increased severity of erosive esophagitis (EE) at 1 year after LSG. MATERIALS AND METHODS: Data on patients who underwent LSG between February 2007 and March 2016 were reviewed. Endoscopic findings and anthropometric data before and after surgery were recorded. The severity of EE was assessed according to the Los Angeles classification; severe EE was defined as grade C or D esophagitis. RESULTS: Totally, 316 patients were enrolled. Before LSG, 96 patients (30.4%) had grade A or B EE. One year after LSG, 215 patients (68%) had EE, including 136 (43%) with grade A, 62 (19.6%) with grade B, and 17 (5.4%) with grade C or D EE. One-hundred and twenty-seven of 220 patients (57.7%) without EE before LSG developed de novo EE following LSG. The incidence of severe EE after LSG in patients without pre-operative EE, grade A EE, or grade B EE at baseline was 3.2%, 6.8%, and 50%, respectively. Independent factors for an increased severity of EE after LSG were male gender (OR = 2.55, 95% CI = 1.52-4.28) and post-operative hiatal hernia (OR = 3.17, 95% CI = 1.66-6.06). CONCLUSION: The prevalence and severity of EE increased after LSG. Male gender and post-operative hiatal hernia are independent factors for an increased severity of EE after LSG. The incidence of severe EE after LSG is low for patients without pre-operative EE or grade A EE at baseline.

Prognostic significance of systemic inflammatory response markers in patients with superficial esophageal squamous cell carcinomas.

Endoscopic resection or esophagectomy has becoming the standard treatment for superficial esophageal squamous cell carcinomas (SESCC), but some patients may develop disease progression or second primary cancers after the therapies. Neutrophil to lymphocyte ratio (NLR), lymphocyte to monocyte ratio (LMR), and platelet to lymphocyte ratio (PLR) reflect the balance between pro-cancer inflammatory and anti-cancer immune responses, however their roles in SESCC are still unknown. We consecutively enrolled patients with newly diagnosed SESCC (clinical stage Tis or T1N0M0) who were treated at our institute. Pre-treatment NLR, LMR and PLR were assessed and then correlated with clinical factors and long-term survival. A total of 156 patients were enrolled (152 males, 4 females; median age: 52.2 years), of whom 104 received endoscopic resection and 52 were treated with esophagectomy or chemoradiation.. During a mean follow-up period of 60.1 months, seventeen patients died of ESCCs, and 45 died of second primary cancers. The 5-year ESCC-specific survival and 5-year overall survival rate were 86% and 57%, respectively. LMR (P < 0.05) and NLR (P < 0.05), but not PLR were significantly correlated with overall survival. Receiver operating characteristic curve analysis showed optimal LMR and NLR cut-off values of 4 and 2.5, respectively, to predict a poor prognosis. Patients with a high NLR or low LMR tended to have longer tumor length, larger circumferential extension, and presence of second primary cancers. Multivariate Cox regression analysis showed that presence of second primary cancers (HR: 5.05, 95%CI: 2.75-9.28), low LMR (HR: 2.56, 95%CI: 1.09-6.03) were independent risk factors for poor survival. A low pre-treatment LMR may be a non-invasive pretreatment predictor of poor prognosis to guide the surveillance program, suggesting that anti-cancer immunity may play a role in the early events of esophageal squamous cancer.

Hepatocellular carcinoma incidence with tenofovir versus entecavir in chronic hepatitis B: a systematic review and meta-analysis.

BACKGROUND: It is unclear whether tenofovir disoproxil fumarate and entecavir differ in their association with risk of hepatocellular carcinoma in patients with chronic hepatitis B, and previous meta-analyses have shown conflicting conclusions with substantial heterogeneity. We aimed to analyse the updated data and elucidate the source of heterogeneity. METHODS: We searched PubMed, Embase, Web of Science, and the Cochrane library for relevant studies with time-to-event data for incident hepatocellular carcinoma occurring in patients with chronic hepatitis B who received tenofovir disoproxil fumarate or entecavir monotherapy with follow-up of at least 1 year. Studies published between Jan 1, 2006, and April 17, 2020, and abstracts from international conferences in 2018 and 2019 were included. We pooled covariate adjusted hazard ratios (HRs) for hepatocellular carcinoma using a random-effects model, assessed heterogeneity among included studies using the I2 statistic and Cochran's Q test, and identified the source of heterogeneity using prespecified subgroup analyses. This study is registered with PROSPERO, ID CRD42020176513. FINDINGS: 31 studies involving 119 053 patients were analysed. The 5-year cumulative incidence of hepatocellular carcinoma was 5·97% (95% CI 5·81-6·13, 28 studies) for entecavir and 3·06% (2·86-3·26, 13 studies) for tenofovir disoproxil fumarate in studies with unmatched populations (p<0·0001). For all eight studies matched by propensity score, the 5-year cumulative incidence was 3·44% (95% CI 3·08-3·80) for entecavir and 3·39% (2·94-3·83) for tenofovir disoproxil fumarate (p=0·87). Analysis of 14 comparative studies with covariate adjustment found that tenofovir disoproxil fumarate and entecavir had similar risk of hepatocellular carcinoma (primary outcome); adjusted HR 0·88, 95% CI 0·73-1·07; p=0·20), although heterogeneity was significant (I2=56·4%, p=0·0038). In a subgroup analysis for hospital-based clinical cohorts, there was no difference in hepatocellular carcinoma incidence between the two regimens (adjusted HR 1·03, 95% CI 0·88-1·21; I2=0%). However, tenofovir disoproxil fumarate was associated with a lower risk of hepatocellular carcinoma compared with entecavir in administrative database research (adjusted HR 0·67, 0·59-0·76; I2=0%). INTERPRETATION: Our study found no significant difference between tenofovir disoproxil fumarate and entecavir in their association with incident hepatocellular carcinoma. We suggest that treatment should be guided by patient tolerability and affordability rather than whether one drug is more effective than the other. FUNDING: Supported in part by E-DA Hospital (EDAHP 106008; EDAHP 103046).

A nationwide population-based study to access the risk of metachronous esophageal cancers in head and neck cancer survivors.

How long esophageal screening should be performed for, and on which sub-groups of head and neck cancer (HNC) survivors, remains uncertain. This retrospective study analyzed data from the Taiwan National Health Insurance Research Database from 1999 to 2013. A total of 68,131 newly- diagnosed HNC patients were enrolled. Subjects who received esophageal endoscopic screening within 6 months after their diagnosis date of index HNC were identified. The incidence trends of secondary primary EC were analyzed using a Cochran-Armitage trend test. Among the 9,707 patients who received index esophageal endoscopy screening, 101 (1.0%) cases of synchronous EC were diagnosed. The 5- and 10-year cumulative incidence rates of metachronous ECs were 1.4% and 2.7%, respectively in those with an initial negative index endoscopic finding. Patients with oropharynx or hypopharynx cancers were at significantly higher risk of developing metachronous ECs compared with those with oral or larynx cancers (10-year incidence rate: 3.3% vs. 0.9%, respectively; hazard ratio: 2.15; 95% confidence intervals: 1.57-2.96). Metachronous EC continues to develop in patients with HNC even at 10-years after treatment for primary HNC. HNC patients, especially those with oropharynx or hypopharynx cancer, may require long-term endoscopic surveillance.

Endoluminal stenting for the management of leak following sleeve gastrectomy and loop duodenojejunal bypass with sleeve gastrectomy.

Postoperative leak is a serious complication of bariatric surgery and often results in significant morbidity and mortality. Stent placement is a less invasive alternative to surgery for the treatment of bariatric surgical leak. We evaluated the efficacy and complications of covered self-expandable metal stents (SEMS) in the treatment of post-bariatric surgical leak. We retrospectively reviewed patients who underwent stent placement for leak after bariatric surgery. Leak was diagnosed by upper gastrointestinal series or was visualized during the endoscopy. We examined the timing of stent placement, size of the leak, stent migration and its complications, total stent treatment duration, and treatment outcome. Between January 2011 and April 2015, seven patients underwent covered SEMS placement for leak after bariatric surgery, including laparoscopic sleeve gastrectomy (LSG) (n = 5) and laparoscopic loop duodenojejunal bypass with sleeve gastrectomy (LDJB-SG) (n = 2). A stent was placed in one patient for infection control and bridging to revisional surgery. Among the other six patients, one patient who received stent placement one year after leak diagnosis failed to achieve leak closure, and five patients with early stent placement achieved leak closure. Three patients with small leak achieved leak closure more quickly. Stent migration was found in six patients, and associated ulcers occurred in five patients. We conclude that stenting is effective in the management of staple-line leaks following LSG and LDJB-SG. Stent migration and associated ulcers are common after stent placement. Early stent removal can be achieved in patients with small leaks.