Self-expandable metal stent for malignant esophagorespiratory fistula: predictive factors associated with clinical failure.

BACKGROUND AND AIMS: Malignant esophagorespiratory fistulas (MERFs) usually are managed by the placement of self-expandable metal stents (SEMSs) but with conflicting results. This study aimed to identify risk factors associated with clinical failure after SEMS placement for the treatment of MERFs. METHODS: This was a retrospective analysis of a prospectively maintained database used at a tertiary-care cancer hospital, with patients treated with SEMS placement for MERFs between January 2009 and February 2016. Logistic regression was used to identify predictive factors for clinical outcomes and to estimate the odds ratio (OR) and the 95% confidence interval (CI). The Kaplan-Meier method was used for survival analysis, and comparisons were made by using the log-rank test. RESULTS: A total of 71 patients (55 male, mean age 59 years) were included in the study, and 70 were considered for the final analysis (1 failed stent insertion). Clinical failure occurred in 44% of patients. An Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 and fistula development during esophageal cancer treatment were associated with an increased risk of clinical failure. ECOG status of 3 or 4, pulmonary infection at the time of SEMS placement, and prior radiation therapy were predictive factors associated with lower overall survival. Dysphagia scores improved significantly 15 days after stent insertion. The overall stent-related adverse event rate was 30%. Stent migration and occlusion caused by tumor overgrowth were the most common adverse events. CONCLUSION: SEMS placement is a reasonable treatment option for MERFs; however, ECOG status of 3 or 4 and fistula development during esophageal cancer treatment may be independent predictors of clinical failure after stent placement.

The Role of Probe-Based Confocal Laser Endomicroscopy (pCLE) in the Diagnosis of Sustained Clinical Complete Response Under Watch-and-Wait Strategy After Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Adenocarcinoma: a Score Validation.

BACKGROUND: Watch-and-wait strategy has been increasingly accepted for patients with clinical complete response (cCR) after multimodal treatment for locally advanced rectal adenocarcinoma. Close follow-up is essential to the early detection of local regrowth. It was previously demonstrated that probe-based confocal laser endomicroscopy (pCLE) scoring using the combination of epithelial and vascular features might improve the diagnostic accuracy of cCR. AIM: To validate the pCLE scoring system in the assessment of patients with cCR after neoadjuvant chemoradiotherapy (nCRxt) for advanced rectal adenocarcinoma. METHODS: Digital rectal examination, pelvic magnetic resonance imaging (MRI), and pCLE were performed in 43 patients with cCR, who presented either a scar (N = 33; 76.7%) or a small ulcer with no signs of tumor, and/or biopsy negative for malignancy (N = 10; 23.3%). RESULTS: Twenty-five (58.1%) patients were men, and the mean age was 58.4 years. During the follow-up, 12/43 (27.9%) patients presented local regrowth and underwent salvage surgery. There was an association between pCLE diagnostic scoring and final histological report (for patients who underwent surgical resection) or final diagnosis at the latest follow-up (p = 0.0001), while this association was not observed with MRI (p = 0.49). pCLE sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 66.7%, 93.5%, 80%, 88.9%, and 86%, respectively. MRI sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 66.7%, 48.4%, 66.7%, 78.9%, and 53.5%, respectively. CONCLUSIONS: pCLE scoring system based on epithelial and vascular features improved the diagnosis of sustained cCR and might be recommended during follow-up. pCLE might add some valuable contribution for identifying local regrowth. Trial Registration This protocol was registered at the Clinical Trials (ClinicalTrials.gov identifier NCT02284802).

Gastric bypass versus best medical treatment for diabetic kidney disease: 5 years follow up of a single-centre open label randomised controlled trial.

Background: We compared the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) to best medical treatment in patients with diabetic kidney disease and obesity to determine which treatment is better. Methods: A 5 year, open-label, single-centre, randomised trial studied patients with diabetic kidney disease and class I obesity after 1:1 randomization to best medical treatment (n = 49) or RYGB (n = 51). The primary outcome was the proportion of patients achieving remission of microalbuminuria after 5 years. Secondary outcomes included improvements in diabetic kidney disease, glycemic control, quality of life, and safety. For efficacy outcomes, we performed an intention-to-treat (ITT) analysis. This study was registered with ClinicalTrials.gov, NCT01821508. Findings: 88% of patients (44 per arm) completed 5-year follow-up. Remission of albuminuria occurred in 59.6% (95% CI = 45.5-73.8) after best medical treatment and 69.7% (95% CI = 59.6-79.8) after RYGB (risk difference: 10%, 95% CI, -7 to 27, P = 0.25). Patients after RYGB were twice as likely to achieve an HbA1c ≤ 6.5% (60.2% versus 25.4%, risk difference, 34.9%; 95% CI = 15.8-53.9, P < 0.001). Quality of life after five years measured by the 36-Item Short Form Survey questionnaire (standardized to a 0-to-100 scale) was higher in the RYGB group than in the best medical treatment group for several domains. The mean differences were 13.5 (95% CI, 5.5-21.6, P = 0.001) for general health, 19.7 (95% CI, 9.1-30.3, P < 0.001) for pain, 6.1 (95% CI, -4.8 to 17.0, P = 0.27) for social functioning, 8.3 (95% CI, 0.23 to 16.3, P = 0.04) for emotional well-being, 12.2 (95% CI, 3.9-20.4, P = 0.004) for vitality, 16.8 (95% CI, -0.75 to 34.4, P = 0.06) for mental health, 21.8 (95% CI, 4.8-38.7, P = 0.01) for physical health and 11.1 (95% CI, 2.24-19.9, P = 0.01) for physical functioning. Serious adverse events were experienced in 7/46 (15.2%) after best medical treatment and 11/46 patients (24%) after RYGB (P = 0.80). Interpretation: Albuminuria remission was not statistically different between best medical treatment and RYGB after 5 years in participants with diabetic kidney disease and class 1 obesity, with 6-7 in ten patients achieving remission of microalbuminuria (uACR <30 mg/g) in both groups. RYGB was superior in improving glycemia, diastolic blood pressure, lipids, body weight, and quality of life. Funding: The study was supported by research grants from Johnson & Johnson Brasil, Oswaldo Cruz German Hospital, and by grant 12/YI/B2480 from Science Foundation Ireland (Dr le Roux) and grant 2015-02733 from the Swedish Medical Research Council (Dr le Roux). Dr Pereira was funded by the Chevening Scholarship Programme (Foreign and Commonwealth Office, UK).

Diagnosis of Clinical Complete Response by Probe-Based Confocal Laser Endomicroscopy (pCLE) After Chemoradiation for Advanced Rectal Cancer.

BACKGROUND: Neoadjuvant chemoradiotherapy (nCRxt) followed by radical surgery is the optimal treatment for advanced rectal adenocarcinoma. Patients with clinical complete response (cCR) may be followed closely without immediate surgery. Probe-based confocal laser endomicroscopy (pCLE) is a real-time in vivo method that allows acquisition of optical biopsies with 1000 times magnification, evaluating both epithelial and vascular patterns. AIM: To evaluate the role of pCLE in the diagnosis of cCR after nCRxt for advanced rectal adenocarcinoma. METHODS: pCLE was performed in 47 patients with locally advanced rectal adenocarcinoma (T3/T4, or N+) who underwent nCRxt (5-fluorouracil, 5040 cGy). RESULTS: Twenty-seven (57.5%) patients were men, and the mean age was 62.8 years. Thirty-seven had partial response confirmed by pCLE. Ten (21.3%) patients had good endoscopic response and presented small ulcer (n = 5) or residual scar (n = 5). After nCRxt, the essential features to differentiate malignancy from post-radiation alterations at pCLE were the presence of irregular crypts, budding, back-to-back glands, cribriform pattern, increased vessel/crypt ratio, and fluorescein leakage. A scoring system was created considering these epithelial and vascular features, with high accuracy for differentiating patients with complete response from those with residual neoplasia (p < 0.00001). pCLE sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 100%, 71.4%, 95.2%, 100%, and 95.7%, respectively. CONCLUSIONS: (1) pCLE evaluation of epithelial and vascular features may improve the diagnosis of cCR and may alter patient management; (2) pCLE might be valuable for identifying patients with advanced rectal cancer who will benefit from watch and wait strategy, avoiding immediate surgical treatment.

Effect of Gastric Bypass vs Best Medical Treatment on Early-Stage Chronic Kidney Disease in Patients With Type 2 Diabetes and Obesity: A Randomized Clinical Trial.

Importance: Early-stage chronic kidney disease (CKD) characterized by microalbuminuria is associated with future cardiovascular events, progression toward end-stage renal disease, and early mortality in patients with type 2 diabetes. Objective: To compare the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) surgery vs best medical treatment in patients with early-stage CKD, type 2 diabetes, and obesity. Design, Setting, and Participants: For this randomized clinical trial, patients with established type 2 diabetes and microalbuminuria were recruited from a single center from April 1, 2013, through March 31, 2016, with a 5-year follow-up, including prespecified intermediate analysis at 24-month follow-up. Intervention: A total of 100 patients with type 2 diabetes, obesity (body mass indexes of 30 to 35 [calculated as weight in kilograms divided by height in meters squared]), and stage G1 to G3 and A2 to A3 CKD (urinary albumin-creatinine ratio [uACR] >30 mg/g and estimated glomerular filtration rate >30 mL/min) were randomized 1:1 to receive best medical treatment (n = 49) or RYGB (n = 51). Main Outcomes and Measures: The primary outcome was remission of albuminuria (uACR <30 mg/g). Secondary outcomes were CKD remission rate, absolute change in uACR, metabolic control, other microvascular complications, quality of life, and safety. Results: A total of 100 patients (mean [SD] age, 51.4 [7.6] years; 55 [55%] male) were randomized: 51 to RYGB and 49 to best medical care. Remission of albuminuria occurred in 55% of patients (95% CI, 39%-70%) after best medical treatment and 82% of patients (95% CI, 72%-93%) after RYGB (P = .006), resulting in CKD remission rates of 48% (95% CI, 32%-64%) after best medical treatment and 82% (95% CI, 72%-92%) after RYGB (P = .002). The geometric mean uACRs were 55% lower after RYGB (10.7 mg/g of creatinine) than after best medical treatment (23.6 mg/g of creatinine) (P < .001). No difference in the rate of serious adverse events was observed. Conclusions and Relevance: After 24 months, RYGB was more effective than best medical treatment for achieving remission of albuminuria and stage G1 to G3 and A2 to A3 CKD in patients with type 2 diabetes and obesity. Trial Registration: ClinicalTrials.gov Identifier: NCT01821508.

Comparison of the pull and introducer percutaneous endoscopic gastrostomy techniques in patients with head and neck cancer.

BACKGROUND AND STUDY AIMS: Percutaneous endoscopic gastrostomy (PEG) in head and neck cancer (HNC) patients is associated with higher complication and mortality rates when compared to a general patient population. The pull technique is still the preferred technique worldwide but it has some limitations. The aim of this study is to compare the pull and introducer PEG techniques in patients with HNC. PATIENTS AND METHODS: This study is based on a retrospective analysis of a prospectively collected database of 309 patients with HNC who underwent PEG in the Cancer Institute of São Paulo. RESULTS: The procedure was performed with the standard endoscope in 205 patients and the introducer technique was used in 137 patients. There was one procedure-related mortality. Age, sex and albumin level were similar in both groups. However in the introducer technique group, patients had a higher tumor stage, a lower Karnofsky status, and presented more frequently with tracheostomy and trismus. Overall, major, minor, immediate and late complications and 30-day mortality rates were similar but the introducer technique group presented more minor bleeding and tube dysfunctions. CONCLUSION: The push and introducer PEG techniques seem to be both safe and effective but present different complication profiles. The choice of PEG technique in patients with HNC should be made individually.