Endoscopic closure of refractory upper GI-tracheobronchial fistulas with a novel occluder: a prospective, single-arm, single-center study (with video).

BACKGROUND AND AIMS: Upper GI-tracheobronchial fistula is a morbid condition with high mortality. It is a challenge for endoscopists because currently available treatments have severe limitations. In this study we assessed the efficacy and safety of an occluder we invented for endoscopic closure of refractory upper GI-tracheobronchial fistulas. METHODS: This was a prospective, single-arm, single-center trial conducted between September 2020 and March 2022. All patients undergoing occluder placement were eligible to enroll. The primary endpoints were clinical success rate (CSR) and complete closure rate (CCR) at 3 months and safety. Secondary efficacy endpoints were technical success rates, CSRs and CCRs at 1 and 6 months, near-complete closure rates, change from baseline in body mass index (BMI), and health-related quality of life (HRQoL) at 1, 3, and 6 months. RESULTS: Twenty-eight patients (mean age, 63.2 years; 23 men) were enrolled. Eighteen through-the-scope occluders (TTSOs) and 10 through-the-overtube occluders (TTOOs) were implanted, with a technical success rate of 100%. The mean procedure time for the TTSO and TTOO groups were 28.0 ± 8.0 minutes and 31.8 ± 7.7 minutes, respectively. The CSRs at 1, 3, and 6 months were 92.9%, 96.4%, and 92.0% and the CCRs were 60.7%, 60.7%, and 60.0%, respectively. The mean BMI at 3 and 6 months and HRQoL at 1, 3, and 6 months were significantly increased compared with baseline (P < .05). Two completely occluded fistulas had 1-sided or complete healing by coverage of granulation tissue and re-epithelialized mucosa at a follow-up of 6 and 12 months. All 14 adverse events were either mild and transient or easily corrected. CONCLUSIONS: Our clinical outcomes suggest that this novel GI occluder is a safe and effective salvage option for patients with refractory upper GI-tracheobronchial fistulas. (Clinical trial registration number: ChiCTR2000038566.).

Comparison of operation time, efficacy and safety between through-the-scope stent and over-the-while stent in malignant central airway obstruction: a multi-center randomized control trial.

Background: Self-expandable metallic (SEM) airway stents are an important approach to treating malignant central airway obstruction (CAO). Standard over-the-while (OTW) stent needs the guidance of a guide-wire. It should be implanted under flouroscopy or the guidance of bronchoscope visualization. In this study, we evaluated the operation time and safety between OTW stent and a novel through-the-scope (TTS) SEM airway stent. Methods: In this multi-center, randomized, parallel-group superiority study, malignant CAO patients were enrolled randomly assigned (2:1) to the TTS stent implantation group (TTS group) or the standard OTW stent group (OTW group) in six sites across China. The entire process of all surgical procedures was recorded by video. Primary endpoint was the operation time of the airway stent implantation and secondary endpoint was the success rate of the stent implantation as well as its efficacy and safety. Results: From May 15, 2017, to December 30, 2018, 148 patients were enrolled from the six sites. We analyzed 134 patients (including 91 patients from the TTS group and 43 patients from the OTW group) according to the per-protocol set. There were no significant differences in the ages, genders, underlying diseases, and stenosis sites between the two groups. The operation time in the TTS group was significantly shorter than that in the OTW group (104±68 vs. 252±111 seconds, P<0.001). Compared to the OTW group, the efficacy of stent implantation (97.80% vs. 90.70%, P=0.093) and rate of first-time successful stent implantation (78.02% vs. 74.42%, P=0.668) were higher in the TTS group, but did not reach statistically significance. The rates of granulation (28.57% vs. 41.86%, P=0.128) and restenosis (15.38% vs. 30.23%, P=0.064) in the TTS group were slightly lower as compared with the OTW group without achieving statistical significance. Conclusions: The TTS stent implantation procedure time was significantly shorter than that of the OTW airway stent with similar efficacy and complications, which might reduce the risk and flexibility of stent implantation. Trial Registration: Chinese Clinical Trial Registry ChiCTR-IOR-17011431.

Diagnostic value of endobronchial ultrasound combined with rapid on-site evaluation of transbronchial lung biopsy for peripheral pulmonary lesions.

BACKGROUND: Rapid on-site evaluation (ROSE) has the potential to increase endobronchial ultrasound (EBUS) guide transbronchial lung biopsy (TBLB) accuracy in the diagnosis of peripheral pulmonary lesions (PPLs). However, studies have reported controversial results. The aim of the study was to evaluate the diagnostic value of EBUS-TBLB combination with ROSE in PPLs. METHODS: A total of 152 patients with PPLs underwent EBUS were enrolled and completed this study. Patients were divided into EBUS combined with ROSE group (EBUS+ROSE group) and EBUS group (EBUS group). The diagnostic yield, operation time, and complications were compared between the two groups. RESULTS: The diagnostic yield in EBUS+ROSE group was 85.9%, the operation time was (24.6 ± 6.8) min, the diagnostic yield in EBUS group was 70.3%, and the operative time was (32.4 ± 8.7) min, there were significant differences in diagnostic yield (χ2 = 5.456, P = .016) and operation time (t = 3.167, P = .001) between the two groups. No severe procedure related complications were observed, such as, pneumothorax and hemorrhage. CONCLUSIONS: ROSE can improve the diagnostic yield and shorten the operation time. EBUS combined with ROSE is an effective diagnostic method for PPLs.

Multiple stents for tracheobronchomalacia caused by hydrochloric acid inhalation: a case report.

Tracheobronchomalacia (TBM) is a rare disease characterized by excessive collapsibility of the central airways during expiration. Potential consequences and treatment courses of the aspiration of erosive agents are seldom reported. To our knowledge, this is the first report of TBM caused by hydrochloric acid inhalation, which was successfully treated by multiple airway stents insertion. A 45-year-old female presented with dyspnea and pharynx discomfort after falling into a hydrochloric acid pool. The patient was successfully treated with multiple stents insertion. In 15 months after the stents insertion, the clinical symptoms have been rapidly improved. Inhaled chemical damage may lead to TBM, while multiple airway stents insertion showed a good therapeutic effect for such special TBM.

Expression of Cripto-1 predicts poor prognosis in stage I non-small cell lung cancer.

Cripto-1 (CR-1) is related to the biological behaviour and prognosis of carcinomas. The purpose of this study was to investigate the significance of CR-1 expression in surgically resected stage I non-small cell lung cancer (NSCLC). One hundred and forty-eight patients with completely resected stage I NSCLC and available clinical follow-up data were assessed. The protein expression of CR-1 in the tumours was detected by immunohistochemistry. CR-1 was highly expressed in 64 of 148 tumours. Among patients with high CR-1 expression, progression-free survival and overall survival rate were significantly lower than those of patients with low CR-1 levels (P = .013 and P = .019, respectively). The incidence of distant metastasis in patients with high CR-1 expression was significantly higher than that of in patients with low CR-1 expression (57.13% vs 21.43%, P = .001). The results of the multivariate analysis confirmed that a high CR-1 was a significant factor for poor prognosis. In conclusion, CR-1 could be a useful prognostic factor in patients with stage I NSCLC, likely as an indicator of the metastatic propensity of the tumour.

The clinical feasibility of flexible bronchoscopy interventional therapy in patients with central airway stenosis and respiratory failure caused by malignancy.

OBJECTIVE: The aim of this study was to investigate the clinical effects and feasibility of using flexible bronchoscopy intervention in cases of malignancy that causes central airway stenosis and respiratory failure. METHODS: The clinical data of patients who were admitted to the Department of Respiratory Medicine at the First Affiliated Hospital of Nanjing Medical University and underwent treatment of a malignant tumor with central airway stenosis and respiratory failure by flexible bronchos-copy from February 2010 to May 2013 were analyzed using a retrospective method. The age, gender, location, extent of airway stenosis, interventional therapy, efficacy, and complications for 12 patients were collected and analyzed using the SPSS 13.0 software. RESULTS: After interventional therapy, the dyspnea index for all the patients improved signifi-cantly, and compared with before treatment, the difference was statistically significant (t=13.40, P<0.01). Eleven patients with respiratory failure were corrected, and only one patient was treated via tracheal intubation with mechanical ventilation. There were no severe complications, such as massive hemorrhaging or cardiac arrest in any case. CONCLUSION: Flexible bronchoscopy interventional treatment for central airway stenosis and respiratory failure caused by malignant tumors is an effective and safe method. It should be applied in clinical work.

[Flexible bronchoscopic intervention for endobronchial hamartoma].

OBJECTIVE: To evaluate the effectiveness and safety of interventional treatment in the removal of endobronchial hamartoma by flexible bronchoscopy. METHODS: A retrospective analysis was conducted in 8 inpatients with histologically confirmed endobronchial hamartoma , diagnosed between May 2009 to January 2012 in the First Affiliated Hospital of Nanjing Medical University. The clinical, radiological and bronchoscopic features of hamartoma, and the clinical outcomes after bronchoscopic intervention were described. The endoscopic interventional treatments included resection by electrosurgical snare, electrocautery, argon plasma coagulation (APC) and cryotherapy. Thoracic computed tomography(CT)and bronchoscopy were used to evaluate the airway stenosis during follow-up. RESULTS: The 8 patients, 7 males and 1 female, aged (62 ± 8) years, underwent 13 times of interventional treatment for endobronchial hamartoma. Four patients were cured after receiving a single endoscopic treatment, while 3 patients had recurrence after initial interventional treatment but were cured after the second treatment. Three times of interventional treatment was carried out in 1 patient who had two relapses but later became stable with a 40% stenosis of the airway lumen. The rates of cure and effectiveness were 87.5% and 100%, respectively. Following interventional treatment, pneumothorax occurred in 1 patient who was cured after oxygen therapy. There were no serious complications such as massive haemorrhage, airway perforation, airway ignition and suffocation. CONCLUSION: Interventional treatments through flexible bronchoscopy appear to be safe and effective for removing endobronchial hamartoma.

Effects of PEG length and iron oxide nanoparticles size on reduced protein adsorption and non-specific uptake by macrophage cells.

At present, the studies showed that applications of magnetic iron oxide nanoparticels in vivo are hampered by their non-specific uptake by the innate immune system. And surface PEGylation of the nanoparticles maybe a feasible approach to escape from the reticular-endothelial system for a long blood circulation half-life. In this paper, we synthesized two sizes of monodisperse nanoparticles and studied the effects of PEG length on reduced protein adsorption and non-specific uptake by macrophage cells for an ideal material with a relatively long blood half-life. The results show that small nanoparticles with high molecular weight PEGylation may be a more applicable candidate due to their size effect and high efficiency in reducing protein adsorption.

[The clinical characteristics and its relationship with metabolic syndrome in elderly subjects with impaired glucose regulation].

OBJECTIVE: To study the clinical characteristics of impaired glucose regulation (IGR) in elderly subjects and its relationship with metabolic syndrome (MS). METHODS: The exploration of IGR in 2 810 Chongqing citizens over 40 years old was done by OGTT in a cross-section study. Normal glucose tolerance (NGT), IGR and diabetes (DM) were grouped based on the1999 diagnosis standard of WHO. IGR was composed of impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and both of which. RESULTS: The prevalence of IGR was 18.11%, among which IGT (85.27%). Compared with the NGT group, the IGR group had higher age, body mass index (BMI), blood pressure, triglyceride (TG), total cholesterol (TC), low density lipoprotein cholesterol (LDL-c) and HOMA-IR, lower high density lipoprotein cholesterol (HDL-c) and HOMA-B. The IGR group had lower blood pressure, TG and HOMA-IR, and higher HOMA-B than the DM group. When each subgroup of IGR was compared with each other, both IFG plus IGT subgroup and IFG subgroup had higher BMI and HOMA-IR, and lower HOMA-B than IGT subgroup. The prevalences of hypertension, lipid disorder, obesity/overweight, and microalbuminuria in each subgroup of IGR were statistically higher than that of the NGT group. The prevalence of MS in the IFG plus IGT subgroup was higher than that of the IGT subgroup. CONCLUSIONS: The incidence of IGR was high in elderly people over 40 years old in local district of Chongqing city. There were various metabolic disorders in the subgroups of IGR. The IFG plus IGT and IFG group had higher BMI, hypertension, microalbuminuria and HOMA-IR, but lower HOMA-B than the IGT group.