A longitudinal cohort study of watch and wait in complete clinical responders after chemo-radiotherapy for localised rectal cancer: study protocol.

BACKGROUND: Rectal Cancer is a common malignancy. The current treatment approach for patients with locally advanced rectal cancer involves neoadjuvant chemoradiotherapy followed by surgical resection of the rectum. The resection can lead to complications and long-term consequences. A clinical complete response is observed in some patients after chemoradiotherapy. A number of recent studies have shown that patients can be observed safely after completing chemoradiotherapy (without surgery), provided clinical complete response has been achieved. In this approach, resection is reserved for cases of regrowth. This is called the watch and wait approach. This approach potentially avoids unnecessary surgical resection of the rectum and the resulting complications. In this study, we will prospectively investigate this approach. METHODS: Adult patients with a diagnosis of rectal cancer planned to receive neoadjuvant long course chemoradiotherapy (± subsequent combination chemotherapy) will be consented into the study prior to commencing treatment. After completing the chemoradiotherapy (± subsequent combination chemotherapy), based on the clinical response, subjects will be allocated to one of the following arms: subjects who achieved a clinical complete response will be allocated to the watch and wait arm and others to the standard management arm (which includes resection). The aim of the study is to determine the rate of local failure and other safety and efficacy outcomes in the watch and wait arm. Patient reported outcome measures and the use of biomarkers as part of the clinical monitoring will be studied in both arms of the study. DISCUSSION: This study will prospectively investigate the safety of the watch and wait approach. We will investigate predictive biomarkers (molecular biomarkers and imaging biomarkers) and patient reported outcome measures in the study population and the cost effectiveness of the watch and wait approach. This study will also help evaluate a defined monitoring schedule for patients managed with the watch and wait approach. This protocol covers the first two years of follow up, we are planning a subsequent study which covers year 3-5 follow up for the study population. TRIAL REGISTRATION: Name of the registry: Australia and New Zealand Clinical Trials Registry (ANZCTR). TRIAL REGISTRATION NUMBER: Trial ID: ACTRN12619000207112 Registered 13 February 2019, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376810.

Concomitant septic arthritis in crystal monoarthritis.

OBJECTIVE: In acute monoarthritis, the presence of crystals in synovial fluid may lead to a diagnosis of crystal arthritis (CA) before septic arthritis (SA) can be excluded by culture. We aimed to identify the frequency of coexistence of CA with SA and to compare these with regard to synovial fluid microscopy, C-reactive protein (CRP), and blood culture. METHODS: We examined 1612 synovial aspirates from 2004 to 2009 retrospectively. Of these, 104 patients with clinically significant SA were identified. These were compared to 295 patients with isolated CA. RESULTS: Five percent of joints with CA had concomitant infection. A high synovial white blood cell (WBC) count and elevated CRP (> 100 mg/l) were predictive of concomitant SA with a sensitivity of 86.4%, specificity of 48.3% and 54.6%, and negative predictive values of 98.5% and 98.7%, respectively. In patients with SA who had a blood culture, 42.5% were positive with a matching organism. SA of the shoulder had a 90% rate of bacteremia. CONCLUSION: Crystals alone in synovial fluid from acute monoarthritis cannot exclude SA, as CA and SA frequently coexist. High WBC counts and elevated CRP are common to both SA and CA. Blood cultures should be collected and septic arthritis considered, even when crystals are present, particularly if the shoulder is affected. The exception is when Gram stain is negative and the CRP is < 100 mg/l and joint WBC count is < 10,000/µl. In these circumstances it is very unlikely that there will be concomitant SA.