Preoperative mediastinal staging in early-stage lung cancer: Targeted nodal sampling is not inferior to systematic nodal sampling.

OBJECTIVE: To determine whether targeted sampling (TS), which omits biopsy of triple- normal lymph nodes (LNs) on positron emission tomography, computed tomography, and endobronchial ultrasound (EBUS), is noninferior to systematic sampling (SS) of mediastinal LNs during EBUS for staging of patients with early-stage non-small cell lung cancer (NSCLC). METHODS: Patients who are clinical nodal (cN)0-N1 with suspected NSCLC eligible for EBUS based on positron emission tomography/computed tomography were enrolled in this prospective, multicenter trial. During EBUS, all patients underwent TS and then crossed over to SS, whereby at least 3 mediastinal LN stations (4R, 4L, 7) were routinely sampled. Gold standard of comparison was pathologic results. Based on the previous feasibility trial, a noninferiority margin of 6% was established for difference in missed nodal metastasis (MNM) incidence between TS and SS. The McNemar test on paired proportions was used to determine MNM incidence for each sampling method. Analysis was per-protocol using a level of significance of P < .05. RESULTS: Between November 2020 and April 2022, 91 patients were enrolled at 6 high-volume Canadian tertiary care centers. A total of 256 LNs underwent TS and SS. Incidence of MNM was 0.78% in SS and 2.34% in TS, with an absolute difference of 1.56% (95% confidence interval, -0.003% to 4.1%; P = .13). This falls within the noninferiority margin. A total of 6/256 LNs from 4 patients who were not sampled by TS were found to be malignant when sampled by SS. CONCLUSIONS: In high-volume thoracic endosonography centers, TS is not inferior to SS in nodal staging of early-stage NSCLC. This results in change of clinical management for a minority of patients.

Preconditioning program reduces the incidence of prolonged hospital stay after lung cancer surgery: Results from the Move For Surgery randomized clinical trial.

BACKGROUND: Lung cancer resection is associated with high rates of prolonged hospital stay. It is presumed that preconditioning with aerobic exercise can shorten the postoperative duration of hospital stay, but this has not yet been demonstrated in trials after lung cancer surgery. The aim of this study was to perform a RCT to determine whether Move For Surgery (MFS), a home-based and wearable technology-enhanced preconditioning program before lung cancer surgery, is associated with a lower incidence of prolonged hospital stay when compared to usual preoperative care. METHODS: Patients undergoing lung resection for early-stage non-small cell lung cancer were enrolled before surgery into this blinded, single-site RCT, and randomized to either the MFS or control group in a 1 : 1 ratio. Patients in the MFS group were given a wearable activity tracker, and education about deep breathing exercises, nutrition, sleep hygiene, and smoking cessation. Participants were motivated/encouraged to reach incrementally increasing fitness goals remotely. Patients in the control group received usual preoperative care. The primary outcome was the difference in proportion of patients with hospital stay lasting more than 5 days between the MFS and control groups. RESULTS: Of 117 patients screened, 102 (87.2 per cent) were eligible, enrolled, and randomized (51 per trial arm). The majority (95 of 102, 93.1 per cent) completed the trial. Mean(s.d.) age was 67.2(8.8) years and there were 55 women (58 per cent). Type of surgery and rates of thoracotomy were not different between arms. The proportion of patients with duration of hospital stay over 5 days was 3 of 45 (7 per cent) in the MFS arm compared to 12 of 50 (24 per cent) in the control arm (P = 0.021). CONCLUSION: MFS, a home-based and wearable technology-enhanced preconditioning program before lung cancer surgery, decreased the proportion of patients with a prolonged hospital stay. Registration number: NCT03689634 (http://www.clinicaltrials.gov).

After lung cancer surgery, many patients are admitted to hospital for a prolonged amount of time. It is believed that exercises undertaken before surgery can shorten the stay in hospital, but this has not yet been studied. This study aimed to find out whether Move For Surgery (MFS), a home-based exercise (preconditioning) program using wearable technology before lung cancer surgery, can decrease the number of patients who are admitted to hospital for a prolonged amount of time. Patients with lung cancer were invited to enter this trial 3­4 weeks before surgery. They were randomly put into the MFS or control group. Patients in the MFS group were given a wearable activity tracker, and education about deep breathing exercises, nutrition, sleep hygiene, and quitting smoking. Participants were encouraged to reach increasing fitness goals each week. Patients in the control group underwent usual preoperative care. The difference between the MFS and control groups in the proportion of patients with duration of stay in hospital exceeding 5 days was studied. There were 102 participants in total, 51 in each group. The majority (95 of 102, 93.1 per cent) completed the trial. The average age of participants was 67 years, and 58 per cent were women. Type of surgery and number of open operations were no different between groups. The proportion of patients with duration of stay greater than 5 days was 3 of 45 (7 per cent) in the MFS group compared with 12 of 50 (24 per cent) in the control group. Therefore, MFS before lung cancer surgery was shown to decrease the number of patients admitted to hospital for a prolonged amount of time.

Robotic Lobectomy Is Cost-effective and Provides Comparable Health Utility Scores to Video-assisted Lobectomy: Early Results of the RAVAL Trial.

OBJECTIVE: The aim of this study was to determine if robotic-assisted lobectomy (RPL-4) is cost-effective and offers improved patient-reported health utility for patients with early-stage non-small cell lung cancer when compared with video-assisted thoracic surgery lobectomy (VATS-lobectomy). BACKGROUND: Barriers against the adoption of RPL-4 in publicly funded health care include the paucity of high-quality prospective trials and the perceived high cost of robotic surgery. METHODS: Patients were enrolled in a blinded, multicentered, randomized controlled trial in Canada, the United States, and France, and were randomized 1:1 to either RPL-4 or VATS-lobectomy. EuroQol 5 Dimension 5 Level (EQ-5D-5L) was administered at baseline and postoperative day 1; weeks 3, 7, 12; and months 6 and 12. Direct and indirect costs were tracked using standard methods. Seemingly Unrelated Regression was applied to estimate the cost effect, adjusting for baseline health utility. The incremental cost-effectiveness ratio was generated by 10,000 bootstrap samples with multivariate imputation by chained equations. RESULTS: Of 406 patients screened, 186 were randomized, and 164 analyzed after the final eligibility review (RPL-4: n=81; VATS-lobectomy: n=83). Twelve-month follow-up was completed by 94.51% (155/164) of participants. The median age was 68 (60-74). There were no significant differences in body mass index, comorbidity, pulmonary function, smoking status, baseline health utility, or tumor characteristics between arms. The mean 12-week health utility score was 0.85 (0.10) for RPL-4 and 0.80 (0.19) for VATS-lobectomy ( P =0.02). Significantly more lymph nodes were sampled [10 (8-13) vs 8 (5-10); P =0.003] in the RPL-4 arm. The incremental cost/quality-adjusted life year of RPL-4 was $14,925.62 (95% CI: $6843.69, $23,007.56) at 12 months. CONCLUSION: Early results of the RAVAL trial suggest that RPL-4 is cost-effective and associated with comparable short-term patient-reported health utility scores when compared with VATS-lobectomy.

Robotic thoracic surgery in Canada: Are patients willing to pay out of pocket?

Robotic-assisted thoracoscopic surgery (RTS) is safe and effective, but is associated with high capital and operating costs that are not reimbursed by the Canadian government. Currently, patients have access to RTS only when it is supported by research or philanthropic funds. In a recent study, we assessed the extent of patient-reported satisfaction with RTS, whether patients would have been willing to pay out of pocket for it, and what factors were associated with patients' willingness to pay. Many patients (290 of 411 [70.56%]) stated that they would have paid the additional $2000 to supplement the government health care coverage to have access to RTS. Factors found to be significantly associated with participants' willingness to pay were an annual income of $60 000 or more (p = 0.034), private insurance coverage (p = 0.007), overall experience with RTS rated as 8 or higher out of 10 (p < 0.001), and overall postoperative postdischarge experience rated as satisfying or very satisfying (p = 0.004).

Discharge When Medically Ready.

QUALITY PROBLEM: The timing and pace of patient discharges are not level-loaded throughout the day at many institutions including ours, an academic medical center and adult Level I trauma center located in Milwaukee, Wisconsin. INITIAL ASSESSMENT: Only 4% of patients were being discharged with rooms marked dirty by 11 AM at our institution. CHOISE OF SOLUTION: We put together a multidisciplinary team of approximately 30 stakeholders to develop a revised process that focused on coordination of discharge activities, plan of care awareness among team members, and communication with patients and families. IMPLEMENTATION: The discharge process was piloted and iteratively adjusted on a single medicine floor. EVALUATION: Our interventions made a noticeable impact on median room "ready to be cleaned" (RTBC) time without having an adverse impact on length of stay. RTBC improved by a median of 39 minutes (P = 0.019), and the proportion of rooms ready to be cleaned by 11 AM increased from 4.19% to 8.13%. LESSONS LEARNED: Having a multidisciplinary team participate in the evaluation and development of a new process was critical. Additionally, implementing solutions on a single unit allowed for rapid iteration of changes.

RAVAL trial: Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer.

BACKGROUND: Retrospective data demonstrates that robotic-assisted thoracoscopic surgery provides many benefits, such as decreased postoperative pain, lower mortality, shorter length of stay, shorter chest tube duration, and reductions in the incidence of common postoperative pulmonary complications, when compared to video-assisted thoracoscopic surgery. Despite the potential benefits of robotic surgery, there are two major barriers against its widespread adoption in thoracic surgery: lack of high-quality prospective data, and the perceived higher cost of it. Therefore, in the face of these barriers, a prospective randomized controlled trial comparing robotic- to video-assisted thoracoscopic surgery is needed. The RAVAL trial is a two-phase, international, multi-centered, blinded, parallel, randomized controlled trial that is comparing robotic- to video-assisted lobectomy for early-stage non-small cell lung cancer that has been enrolling patients since 2016. METHODS: The RAVAL trial will be conducted in two phases: Phase A will enroll 186 early-stage non-small cell lung cancer patients who are candidates for minimally invasive pulmonary lobectomy; while Phase B will continue to recruit until 592 patients are enrolled. After consent, participants will be randomized in a 1:1 ratio to either robotic- or video-assisted lobectomy, and blinded to the type of surgery they are allocated to. Health-related quality of life questionnaires will be administered at baseline, postoperative day 1, weeks 3, 7, 12, months 6, 12, 18, 24, and years 3, 4, 5. The primary objective of the RAVAL trial is to determine the difference in patient-reported health-related quality of life outcomes between the robotic- and video-assisted lobectomy groups at 12 weeks. Secondary objectives include determining the differences in cost-effectiveness, and in the 5-year survival data between the two arms. The results of the primary objective will be reported once Phase A has completed accrual and the 12-month follow-ups are completed. The results of the secondary objectives will be reported once Phase B has completed accrual and the 5-year follow-ups are completed. DISCUSSION: If successfully completed, the RAVAL Trial will have studied patient-reported outcomes, cost-effectiveness, and survival of robotic- versus video-assisted lobectomy in a prospective, randomized, blinded fashion in an international setting. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02617186. Registered 22-September-2015. https://clinicaltrials.gov/ct2/show/NCT02617186.

Routine systematic sampling versus targeted sampling during endobronchial ultrasound: A randomized feasibility trial.

OBJECTIVE: Triple normal lymph nodes, appearing benign on computed tomography, positron emission tomography, and endobronchial ultrasound, have less than a 6% probability of malignancy. We hypothesized that targeted sampling (TS), which omits biopsy of triple normal lymph nodes during endobronchial ultrasound, is not an inferior staging strategy to systematic sampling (SS) of all lymph nodes. METHODS: A prospective randomized feasibility trial was conducted to decide on the progression to a pan-Canadian trial comparing TS with SS. Patients with cN0-N1 non-small cell lung cancer undergoing endobronchial ultrasound were randomized to TS or SS. Lymph nodes in the TS arm crossed over to receive SS. Progression criteria included recruitment rate (70% minimum), procedure length (no significant increase for TS), and incidence of missed nodal metastasis (<6%). Mann-Whitney U test and McNemar's test on paired proportions were used for statistical comparisons. RESULTS: The progression criterion of 70% recruitment rate was achieved early, triggering a planned early stoppage of the trial. Nineteen patients were allocated to each arm. The median procedure length for TS was significantly shorter than SS (3.07 vs 19.07 minutes; P < .001). After crossover analysis, 5.45% (95% confidence interval, 1.87-14.85) of lymph nodes in the TS arm were upstaged from N0 to N2, but this incidence of missed nodal metastasis was below the 6% threshold. During surgical resection, the nodal upstaging incidence from N0 to N2 was 0% for 15 lymph nodes in each arm. CONCLUSIONS: Progression criteria to a pan-Canadian, noninferiority crossover trial comparing TS with SS have been met, and such a trial is warranted.

Localized surgical debridement for the management of orbital mucormycosis.

PURPOSE: To describe the role of localized debridement and instillation of amphotericin B for the management of orbital mucormycosis post COVID-19 infection with a view to avoid exenteration. METHODS: The records of all patients with orbital mucormycosis post COVID-19 infection in the last 6 months from December 2020 to June 2021 were evaluated, and ten patients were identified who were successfully managed with localized debridement, that is, removing the fungal tissue and necrotic material and amphotericin B gel instillation locally. MRI scan was used to identify the area of fungal infiltration and presence of necrotic material. Early surgery in the form of transconjunctival orbitotomy was performed for disease in the infraorbital fissure area, and superior transcutaneous lid crease approach was employed for disease in the superomedial orbit or medial orbit. Most patients had lid edema, ptosis, and proptosis; this resolved with the medication. Systemic antifungals were given and the follow-up ranged from 1 to 5 months. RESULTS: The ptosis, proptosis, and lid edema subsided in all, except in one patient who had residual ptosis and in one who had residual ophthalmoplegia. Vision deficit did not occur in any patient. All patients were successfully discharged on oral antifungal medication. CONCLUSION: Localized clearance of the fungal tissue and the necrotic material is a good option to avoid exenteration in cases of orbital mucormycosis, avoiding disfigurement and mental trauma to the patient.

An Artificial Intelligence Algorithm to Predict Nodal Metastasis in Lung Cancer.

BACKGROUND: Endobronchial ultrasound (EBUS) has features that allow a high accuracy for predicting lymph node (LN) malignancy. However their clinical application remains limited because of high operator dependency. We hypothesized that an artificial intelligence algorithm (NeuralSeg; NeuralSeg Ltd, Hamilton, Ontario, Canada) is capable of accurately identifying and predicting LN malignancy based on EBUS images. METHODS: In the derivation phase EBUS images were segmented twice by an endosonographer and used as controls in 5-fold cross-validation training of NeuralSeg. In the validation phase the algorithm was tested on new images it had not seen before. Logistic regression and receiver operator characteristic curves were used to determine NeuralSeg's capability of discrimination between benign and malignant LNs, using pathologic specimens as the gold standard. RESULTS: Two hundred ninety-eight LNs from 140 patients were used for derivation and 108 LNs from 47 patients for validation. In the derivation cohort NeuralSeg was able to predict malignant LNs with an accuracy of 73.8% (95% confidence interval [CI], 68.4%-78.7%). In the validation cohort NeuralSeg had an accuracy of 72.9% (95% CI, 63.5%-81.0%), specificity of 90.8% (95% CI, 81.9%-96.2%), and negative predictive value of 75.9% (95% CI, 71.5%-79.9%). NeuralSeg showed higher diagnostic discrimination during validation compared with derivation (c-statistic = 0.75 [95% CI, 0.65-0.85] vs 0.63 [95% CI, 0.54-0.72], respectively). CONCLUSIONS: NeuralSeg is able to accurately rule out nodal metastasis and can possibly be used as an adjunct to EBUS when nodal biopsy is not possible or inconclusive. Future work to evaluate the algorithm in a clinical trial is required.

Vaginal Carcinoma with Third-Degree Uterine Prolapse.

Carcinoma of vagina in a case of uterovaginal (UV) prolapse is very rare. We hereby present a case of 72-year-old woman with uterine prolapse with ulcerative growth of 4 cm × 2 cm on vagina commonly considered as decubitus ulcer. However, for confirmation, punch biopsy was performed, which confirmed it as vaginal carcinoma. The patient underwent vaginal hysterectomy with colpoperineorrhaphy with wide excision of tumor margin and received radiotherapy postoperatively. This case illustrates the importance of biopsy of an ulcer in cases of UV prolapse to rule out malignancy to avoid incomplete treatment.

Near-infrared mapping with indocyanine green is associated with an increase in oncological margin length in minimally invasive segmentectomy.

BACKGROUND: Near-infrared fluorescence mapping with indocyanine green dye is a recent advancement in minimally invasive segmental resection. This technique has not yet been reproduced, validated, or objectively evaluated in a large prospective case series. We hypothesized that near-infrared fluorescence mapping is associated with an increased oncological margin distance from the tumor, over and above the best judgment of the surgeon. METHODS: This was a phase 2 prospective cohort trial in patients who are undergoing robotic segmentectomy for lung tumors <3 cm. The predicted intersegmental plane was first identified by consensus between 2 thoracic surgeons. The true plane was then mapped by indocyanine green injection. A 7-item binary rating scale was used for the evaluation of feasibility, reproducibility, and added oncological margin distance from the tumor. The margin distance between the tumor and the true plane was compared with the margin distance between the tumor and the predicted plane. RESULTS: Fifty-three patients were enrolled between September 2016 and May 2018 and 31 patients (58.4%) received the planned operation with indocyanine green mapping. In 74.2% of cases (23 out of 31), a score of 7 out of 7 was achieved, indicating the true intersegmental plane identified by indocyanine green mapping was different than the predicted plane identified by the surgeon. In 61.2% (19 out of 31) of those cases, the mean additional margin distance from the tumor to the staple line attributable to the indocyanine green mapping was 2.41 ± 1.6 cm. The overall complication rate was 18.5% (10 out of 53) and there were no deaths. CONCLUSIONS: Near-infrared fluorescence mapping in robotic segmentectomy is associated with increased oncological margin length, over and above the best judgment of the surgeon, in the majority cases where it is used.

Impaired Pulmonary Lung Functions in Workers Exposed to Bagasse: Is Obesity an Added Risk?

CONTEXT: Effect of obesity and dust exposure on lung functions. AIM: To assess the pulmonary functions in asymptomatic, dust-exposed sugarcane factory workers with obesity as an added risk. SETTINGS AND DESIGN: A cross-sectional study. MATERIALS AND METHODS: The present study was conducted in one of the reputed sugarcane factories in Karnataka. One hundred and fifty asymptomatic male workers working in sugarcane factory were included in the study. Based on exposure to sugarcane dust and body mass index (BMI), subjects were categorized into normal weight (not exposed to sugarcane dust), overweight and obese (not exposed to sugarcane dust), and overweight and obese (exposed to sugarcane dust). Adiposity markers such as waist circumference and hip circumference were measured; waist hip ratio, waist stature ratio, and body fat% were calculated. Lung volumes such as forced vital capacity (FVC in L), forced expiratory volume in 1 s (FEV1 in L), forced expiratory flow during 25-75% of expiration (FEF25-75% in L/s), and FEV1/FVC%, peak expiratory flow rate (PEFR in L/min) were measured by digital spirometer. STATISTICAL ANALYSIS USED: Comparison between groups was done by one-way analysis of variance with post hoc analysis. RESULTS: Significant lower values for FEV1 in obese and PEFR among overweight and obese exposed to dust compared to overweight and obese not exposed to dust. CONCLUSIONS: We observed significant decrease in FEV1(L) in obese workers exposed to dust and significant lower PEFR (L/min) in overweight and obese workers exposed to dust, indicative of obstructive pattern of lung disease as a result of occupation-related sugarcane dust exposure in overweight and obese workers in whom already some lung functions are impaired owing to their BMI status, thus indicating that obesity is an added risk.

Effect of drugs modulating serotonergic system on the analgesic action of paracetamol in mice.

OBJECTIVE: The underlying mechanisms for the analgesic action of paracetamol (PCT) are still under considerable debate. It has been recently proposed that PCT may act by modulating the Serotonin system. This study was conducted to verify the influence of Serotonin modulating drugs (buspirone, ondansetron, and fluoxetine) on the analgesic effect of PCT. MATERIALS AND METHODS: Thirty adult albino mice were assigned to five groups: Normal saline, PCT, fluoxetine selective serotonin reuptake inhibitor (SSRI) + PCT, buspirone (5-HT1A Agonist) + PCT, and ondansetron (5HT3 antagonist) + PCT. Hot-plate and formalin test were used to determine pain threshold, tests being conducted 60 min after the last treatment. Statistical analysis was done using analysis of variance followed by Dunnet's test. RESULTS: Coadministration of buspirone with PCT attenuated the antinociceptive activity of PCT (P < 0.001), whereas fluoxetine + PCT increased pain threshold in the hot-plate and formalin test (P = 0.0046). Analgesic effect of PCT was not affected by ondansetron in formalin models. It attenuated analgesic action of PCT in hot-plate test (P = 0.0137). CONCLUSION: The results suggest that 5-HT1 receptors could also be responsible for the analgesic effect of PCT. Also, higher analgesia is produced by co-administration of SSRI (fluoxetine) + PCT.

Effect of l-Thyroxine on Micronuclei Frequency in Peripheral Blood Lymphocytes in Clinical and Experimental Conditions.

The aim was to study the genotoxic effect of high concentration of thyroxine (T4) in vivo in peripheral blood lymphocytes (PBL) of the patients suffering from thyroid disorders. The effect was compared by performing in vitro experiments with addition of increasing concentration of T4 (0.125-1 µM) in whole blood samples from healthy donors. Cytokinesis-blocked micronuclei (CBMN) assay method was used to assess the DNA damage in the PBL. The study included 104 patients which were grouped as control (n = 49), hyperthyroid (n = 31) and hypothyroid (n = 24). A significant increase in micronuclei (MN) frequency was observed in hyperthyroid patients when compared with the hypothyroid and euthyroid group thereby suggesting increased genotoxicity in hyperthyroidism (p < 0.001). A significant increase in MN frequency was observed at T4 concentration of 0.5 µM and above when compared to lower T4 concentrations (0.125 and 0.25 µM) and basal in in vitro experiments (p = 0.000). The results indicate that the T4 in normal concentration does not exhibit the genotoxic effect, as observed in both the in vivo and in vitro experiments. The toxicity of T4 increases at and above 0.5 µM concentration in vitro. Therefore acute T4 overdose should be handled promptly and effectively so as to avoid the possible genotoxic effect of high concentration of T4 in vivo.

Radioprotective effect of Ocimum sanctum and amifostine on the salivary gland of rats after therapeutic radioiodine exposure.

The current study investigated the radioprotective effect of Ocimum sanctum on the salivary gland of rats administered radioiodine ((131)I) and compared its efficacy with a known radioprotectant, amifostine. The experimental rats were divided in four groups and sacrificed in three different batches at 1, 3, and 6 months of time interval after 18.5 MBq/100g (i.p.) (131)I exposure. Six months duration batch received (131)I exposure twice with the gap of 3 months. Two groups of experimental rats were presupplemented with O. sanctum (40 mg/kg for 5 days, orally) and amifostine (200 mg/kg, s.c) before (131)I exposure separately. Increased Technetium-99m-pertechnetate ((99m)TcO(4)(-)) uptake at 30 minutes post injection in salivary glands of only (131)I exposed rats may imply delay in clearance at 6 months of exposure in comparison to their counterparts sacrificed at 1 month. Parotid gland histology showed atrophy with lipomatosis in only (131)I exposed rats at 3 and 6 months of duration. O. sanctum and amifostine presupplemented and subsequently exposed to (131)I rats at 3 and 6 months duration exhibited comparable histopathology with controls. Our study indicates possible radioprotective effect of O. sanctum and amifostine against high-dose (131)I exposure.

Effect of Ocimum sanctum, turmeric extract and vitamin E supplementation on the salivary gland and bone marrow of radioiodine exposed mice.

Significant increase in the salivary gland weight was observed after exposure to single therapeutic dose of 3.7 MBq of 131I in mice. Pre-supplementation of antioxidants, O. sanctum leaf extract, turmeric extract and vitamin E for 15 days before 131I exposure demonstrated significant reduction in the salivary gland weight. No major histopathological changes were observed in the salivary gland of experimental animals at 24 h of exposure. Micronuclei index in the bone marrow of polychromatic (PCEs) and normochromatic erythrocytes (NCEs) remained unchanged in all the experimental groups. However, PCE/NCE ratio in the bone marrow decreased significantly in all the 131I exposed animals irrespective of antioxidant supplementation status. The normalization of salivary gland weight by antioxidant pre-supplementation in radioiodine exposed mice is suggestive of the possible ameliorating effect of antioxidants on the salivary gland weight recommending further detailed studies regarding the functional aspect of the salivary gland in higher animals.

Micronuclei frequency in peripheral blood lymphocytes of thyroid cancer patients after radioiodine therapy and its relationship with metastasis.

In most cancers peripheral blood lymphocytes exhibit DNA damage. In the case of thyroid cancer the micronucleus (MN) assay has been used to assess DNA damage before and after exposure to iodine-131 ((131)I). The aim of our study was to use this method to assess DNA damage in peripheral blood lymphocytes of thyroid cancer patients and search for its relationship with metastasis as well as (131)I exposure. A significant increase in micronuclei frequency was observed in peripheral blood lymphocytes of 54 thyroid cancer patients in comparison to 38 controls (p=0.000). Further analysis revealed significant elevation in micronuclei index from 48.5 MN/1000 BN cells (range: 25.1-111.2, n=25) in patients without metastasis to 68.1 MN/1000 BN cells (range: 26.2-135.5, n=29, p=0.001) in group of patients with metastasis to one or more sites. There was no clear correlation between the micronuclei frequency and the therapeutic (131)I dose ranging from 0.41 to 31.5 GBq with the exposure interval of <1 to 126 months. In addition, age and sex did not show any influence on micronuclei frequency in either patients or control population. These findings are indicative of increased basal DNA damage in thyroid cancer patients before treatment. Radioiodine treatment did not increase DNA damage measured by the micronuclei frequency for the interval between the last radioiodine dose administered and analysis of blood sample. However a significant increase of peripheral blood lymphocytes micronuclei was observed in thyroid cancer patients with metastasis.

Evaluation of the radioprotective effect of turmeric extract and vitamin E in mice exposed to therapeutic dose of radioiodine.

The aim of this study was to evaluate the radioprotective effect of turmeric extract (40 mg/kg body weight) and vitamin E (α- tocopherol acetate, 400 IU/kg body weight) supplementation on lipid peroxidation, reduced glutathione and antioxidant defense enzymes in various organs like liver, kidney and salivary glands at 24 h in adult Swiss mice. (131)Iodine exposure significantly increased lipid peroxidation in kidney and salivary glands in comparison to control animals. Pre supplementation with turmeric extract for 15 days showed significant lowering of lipid peroxidation in kidney. On the other hand vitamin E pre supplementation showed marked reduction in lipid peroxidation in salivary glands. Reduced glutathione levels decreased significantly in liver after radiation exposure. However, pre supplementation with turmeric extract and vitamin E did not improve glutathione levels in liver. In conclusion, we have observed differential radioprotective effect of turmeric extract and vitamin E in kidney and salivary glands. However, Vitamin E seems to offer better radioprotection for salivary glands which is known to be the major site of cellular destruction after radioiodine therapy in patients.

Protective effect of Ocimum sanctum L after high-dose 131iodine exposure in mice: an in vivo study.

Radioprotective effect of aqueous extract of Ocimum sanctum (40 mg/kg body weight, for 15 days) in mice exposed to high-doses (3.7 MBq) of oral 131iodine was investigated by studying the organ weights, lipid peroxidation and antioxidant defense enzymes in various target organs like liver, kidneys, salivary glands and stomach at 24 hr after exposure in adult Swiss mice. The mean weight of the salivary glands showed significant increase after 131iodine administration. 131iodine exposure significantly increased lipid peroxidation in kidneys and salivary glands in comparison to control animals. Pretreatment with O. sanctum in radioiodine exposed group showed significant reduction in lipid peroxidation in both kidneys and salivary glands. In liver, reduced glutathione (GSH) levels showed significant reduction after radioiodine exposure while pretreatment with O. sanctum exhibited less depletion in GSH level even after 131iodine exposure. However, no such changes were observed in stomach. The results indicate the possibility of using aqueous extract of O. sanctum for ameliorating 131Iodine induced damage to the salivary glands.