Oncogenética e Estatuto da Pessoa com Câncer: fundamentos bioético-jurídicos / Oncogenetics and Status of Cancer Patients: bioethical and legal foundations / Oncogenética y Estatuto de la Persona con Cáncer: fundamentos bioético-legales

Resumo Este artigo visa analisar fundamentos da bioética e do direito que contribuíram para estabelecer a disciplina normativa atual do acesso aos recursos da oncogenética sob a perspectiva do Estatuto da Pessoa com Câncer. Buscou-se avaliar o estado atual da legislação que apregoa os direitos dos pacientes quanto às demandas oncológicas, tendo em vista a fundamentalidade dos direitos à vida e à saúde. A premissa central foi esclarecer a situação dos recursos relacionados à oncologia, o que inclui a medicina de precisão e a oncogenética, para, posteriormente, abordar as limitações sobre o seu acesso, no âmbito do Sistema Único de Saúde ou da saúde suplementar. A pesquisa tem natureza teórica, consistindo em levantamento de referências nacionais e estrangeiras, em publicações especializadas, bem como na legislação brasileira vigente.

Abstract This paper analyzes bioethical and legal foundations that contributed to establish the current normative discipline of access to oncogenetic resources from the perspective of the Statute of the Person with Cancer. It sought to evaluate the current state of legislation that upholds the rights of patients regarding oncological demands, considering the fundamental rights to life and health. The central premise was to clarify the status of oncology-related resources, which includes precision medicine and oncogenetics, to subsequently address limitations on their access within the Unified Health System or supplementary health. This is a theoretical research based on the survey of national and international references, specialized publications, and current Brazilian legislation.

Resumen Este artículo tiene como objetivo analizar los fundamentos de la bioética y del derecho que contribuyeron a establecer la disciplina normativa vigente del acceso a los recursos oncogenéticos desde la perspectiva del Estatuto de la Persona con Cáncer. Su objetivo es evaluar el estado actual de la legislación que trata los derechos de los pacientes frente a las demandas oncológicas, considerando los derechos a la vida y a la salud como fundamentales. La premisa central fue esclarecer la situación de los recursos relacionados con la oncología, que incluye la medicina de precisión y la oncogenética, para posteriormente abordar las limitaciones en su acceso en el ámbito del Sistema Único de Salud o de la salud complementaria. El estudio de naturaleza teórica realizó una búsqueda de referencias nacionales y extranjeras de publicaciones especializadas, así como en la legislación brasileña vigente.

Cancer risk-reducing surgery: Brazilian society of surgical oncology guideline part 1 (gynecology and breast).

BACKGROUND: Risk-reducing operations are an important part of the management of hereditary predisposition to cancer. In selected cases, they can considerably reduce the morbidity and mortality associated with cancer in this population. OBJECTIVES: The Brazilian Society of Surgical Oncology (BSSO) developed this guideline to establish national benchmarks for cancer risk-reducing operations. METHODS: The guideline was prepared from May to December 2021 by a multidisciplinary team of experts to discuss the surgical management of cancer predisposition syndromes. Fourteen questions were defined and assigned to expert groups that reviewed the literature and drafted preliminary recommendations. Following a review by the coordinators and a second review by all participants, the groups made final adjustments, classified the level of evidence, and voted on the recommendations. RESULTS: For all questions including risk-reduction bilateral salpingo-oophorectomy, hysterectomy, and mastectomy, major agreement was achieved by the participants, always using accessible alternatives. CONCLUSION: This and its accompanying article represent the first guideline in cancer risk reduction surgery developed by the BSSO, and it should serve as an important reference for the management of families with cancer predisposition.

Mutational spectrum of breast cancer susceptibility genes among women ascertained in a cancer risk clinic in Northeast Brazil.

PURPOSE: There is a paucity of data on the spectrum and prevalence of pathogenic variants among women of African ancestry in the Northeast region of Brazil. METHODS: We performed BROCA panel sequencing to identify inherited loss-of-function variants in breast cancer susceptibility genes among 292 Brazilian women referred to a single institution cancer risk assessment program. RESULTS: The study included a convenient cohort of 173 women with invasive breast cancer (cases) and 119 women who were cancer-free at the time of ascertainment. The majority of the women self-reported as African-descended (67% for cases and 90.8% for unaffected volunteers). Thirty-seven pathogenic variants were found in 36 (20.8%) patients. While the spectrum of pathogenic variants was heterogeneous, the majority (70.3%) of the pathogenic variants were detected in high-risk genes BRCA1, BRCA2, PALB2, and TP53. Pathogenic variants were also found in the ATM, BARD1, BRIP1, FAM175A, FANCM, NBN, and SLX4 genes in 6.4% of the affected women. Four recurrent pathogenic variants were detected in 11 patients of African ancestry. Only one unaffected woman had a pathogenic variant in the RAD51C gene. Different risk assessment models examined performed well in predicting risk of carrying germline loss-of-function variants in BRCA1 and/or BRCA2 in breast cancer cases. CONCLUSION: The high prevalence and heterogenous spectrum of pathogenic variants identified among self-reported African descendants in Northeast Brazil is consistent with studies in other African ancestry populations with a high burden of aggressive young onset breast cancer. It underscores the need to integrate comprehensive cancer risk assessment and genomic testing in the management of newly diagnosed Black women with breast cancer across the African Diaspora, enabling improved cancer control in admixed underserved and understudied populations.

Detection of germline variants in Brazilian breast cancer patients using multigene panel testing.

Genetic diversity of germline variants in breast cancer (BC) predisposition genes is unexplored in miscegenated populations, such those living in Latin America. We evaluated 1663 Brazilian BC patients, who underwent hereditary multigene panel testing (20-38 cancer susceptibility genes), to determine the spectrum and prevalence of pathogenic/likely pathogenic (P/LP) variants and variants of uncertain significance (VUS). Associations between P/LP variants and BC risk were estimated in a case-control analysis of BC patients and 18,919 Brazilian reference controls (RC). In total, 335 (20.1%) participants carried germline P/LP variants: 167 (10.0%) in BRCA1/2, 122 (7.3%) in BC actionable non-BRCA genes and 47 (2.8%) in candidate genes or other cancer predisposition genes. Overall, 354 distinctive P/LP variants were identified in 23 genes. The most commonly mutated genes were: BRCA1 (27.4%), BRCA2 (20.3%), TP53 (10.5%), monoallelic MUTYH (9.9%), ATM (8.8%), CHEK2 (6.2%) and PALB2 (5.1%). The Brazilian variant TP53 R337H (c.1010G>A, p.Arg337His), detected in 1.6% of BC patients and 0.1% of RC, was strongly associated with risk of BC, OR = 17.4 (95% CI: 9.4-32.1; p < 0.0001); monoallelic MUTYH variants c.1187G>A and c.536A>G, detected in 1.2% (0.9% RC) and 0.8% (0.4% RC) of the patients, respectively, were not associated with the odds of BC, the former with OR = 1.4 (95% CI: 0.8-2.4; p = 0.29) and the latter with OR = 1.9 (95% CI: 0.9-3.9; p = 0.09). The overall VUS rate was 46.1% for the entire patient population. Concluding, the use of multigene panel testing almost doubled the identification of germline P/LP variants in clinically actionable predisposition genes in BC patients. In Brazil, special attention should be given to TP53 P/LP variants.

Frequency of CDH1 germline variants and contribution of dietary habits in early age onset gastric cancer patients in Brazil.

INTRODUCTION: The contribution of CDH1 germline variants to gastric cancer burden among young adults is unknown in Brazil. We aimed to evaluate the frequency of CDH1 germline variants and the diet/lifestyle habits in early age onset gastric cancer (EOGC, ≤ 55 years old) patients. METHODOLOGY: From 2013 to 2015, a total of 88 unrelated and consecutive patients diagnosed with EOGC were enrolled. All CDH1 exons and intronic boundaries were sequenced, and large genomic rearrangements were screened by MLPA. CDH1 transcription analysis was performed for variants that could potentially induce an effect on splicing. The diet and lifestyle habits of EOGC patients were compared to Brazilian population diet and lifestyle, obtained from governmental databases. RESULTS: Of 88 patients, the mean age at EOGC diagnosis was 39 years and 55% fulfilled the criteria for hereditary diffuse gastric cancer. The majority of the tumors were diffuse (74%) and poorly differentiated (80%). In total, 4 novel missense variants of uncertain significance (VUS) were identified: c.313T>A, c.387G>T, c.1676G>A, and c.1806C>A. The MLPA results revealed no rearrangements and CDH1 transcription analysis for variants of interest were inconclusive. EOGC patients had a higher red (OR:2.6, 95%CI:1.4-4.9) and processed (OR:3.1, 95%CI:1.6-6.0) meat intake and higher fruit consumption (OR:0.4, 95%IC:0.3-0.7) compared to eating habits of the Brazilian population. CONCLUSIONS: No unequivocal pathogenic germline CDH1 variants were identified in Brazilian EOGC patients. Dietary habits may be associated with the EOGC development.

Personalizing Precision Oncology Clinical Trials in Latin America: An Expert Panel on Challenges and Opportunities.

The participation of patients in precision oncology trials needs to fulfill molecular-based selection criteria. This strongly limits accrual, and as a consequence, screening successes have decreased, costs have increased, and fewer subjects are enrolled. To achieve narrowed targets, studies have been forced to be multicenter and multinational to reach a larger pool of candidates. However, this globalization faces many challenges, as, for example, in the case of precision oncology trials. These trials have a complex structure that is dependent upon a high-tech infrastructure and knowledge in a dynamic environment. Given the movement of precision clinical cancer research to regions other than Europe and the U.S., it is important to evaluate the feasibility of performing such trials in lower-middle- and low-income countries. Here we critically discuss the advantages of conducting precision oncology clinical trials in Latin America and make suggestions on how to overcome the main challenges involved. IMPLICATIONS FOR PRACTICE: Precision clinical trials in oncology are studies that require candidates to have tumors with specific molecular alterations, which are considered the target for the trial experimental therapy. Because many molecular alterations are rare, fewer patients are enrolled. This has led to trials being forced to be multicenter and multinational, including trials in Latin America. This article discusses the challenges and opportunities to conduct precision oncology trials in Latin America, aiming to help sponsors and investigators to solve complex issues that ultimately lead to more of such trials being run in the region, potentially benefiting more Latin American patients with cancer.

Intensive Surveillance with Biannual Dynamic Contrast-Enhanced Magnetic Resonance Imaging Downstages Breast Cancer in BRCA1 Mutation Carriers.

PURPOSE: To establish a cohort of high-risk women undergoing intensive surveillance for breast cancer.Experimental Design: We performed dynamic contrast-enhanced MRI every 6 months in conjunction with annual mammography (MG). Eligible participants had a cumulative lifetime breast cancer risk ≥20% and/or tested positive for a pathogenic mutation in a known breast cancer susceptibility gene. RESULTS: Between 2004 and 2016, we prospectively enrolled 295 women, including 157 mutation carriers (75 BRCA1, 61 BRCA2); participants' mean age at entry was 43.3 years. Seventeen cancers were later diagnosed: 4 ductal carcinoma in situ (DCIS) and 13 early-stage invasive breast cancers. Fifteen cancers occurred in mutation carriers (11 BRCA1, 3 BRCA2, 1 CDH1). Median size of the invasive cancers was 0.61 cm. No patients had lymph node metastasis at time of diagnosis, and no interval invasive cancers occurred. The sensitivity of biannual MRI alone was 88.2% and annual MG plus biannual MRI was 94.1%. The cancer detection rate of biannual MRI alone was 0.7% per 100 screening episodes, which is similar to the cancer detection rate of 0.7% per 100 screening episodes for annual MG plus biannual MRI. The number of recalls and biopsies needed to detect one cancer by biannual MRI were 2.8 and 1.7 in BRCA1 carriers, 12.0 and 8.0 in BRCA2 carriers, and 11.7 and 5.0 in non-BRCA1/2 carriers, respectively. CONCLUSIONS: Biannual MRI performed well for early detection of invasive breast cancer in genomically stratified high-risk women. No benefit was associated with annual MG screening plus biannual MRI screening.See related commentary by Kuhl and Schrading, p. 1693.

From colorectal cancer pattern to the characterization of individuals at risk: Picture for genetic research in Latin America.

Colorectal cancer (CRC) is one of the most common cancers in Latin America and the Caribbean, with the highest rates reported for Uruguay, Brazil and Argentina. We provide a global snapshot of the CRC patterns, how screening is performed, and compared/contrasted to the genetic profile of Lynch syndrome (LS) in the region. From the literature, we find that only nine (20%) of the Latin America and the Caribbean countries have developed guidelines for early detection of CRC, and also with a low adherence. We describe a genetic profile of LS, including a total of 2,685 suspected families, where confirmed LS ranged from 8% in Uruguay and Argentina to 60% in Peru. Among confirmed LS, path_MLH1 variants were most commonly identified in Peru (82%), Mexico (80%), Chile (60%), and path_MSH2/EPCAM variants were most frequently identified in Colombia (80%) and Argentina (47%). Path_MSH6 and path_PMS2 variants were less common, but they showed important presence in Brazil (15%) and Chile (10%), respectively. Important differences exist at identifying LS families in Latin American countries, where the spectrum of path_MLH1 and path_MSH2 variants are those most frequently identified. Our findings have an impact on the evaluation of the patients and their relatives at risk for LS, derived from the gene affected. Although the awareness of hereditary cancer and genetic testing has improved in the last decade, it is remains deficient, with 39%-80% of the families not being identified for LS among those who actually met both the clinical criteria for LS and showed MMR deficiency.

Survival and prognosis of young adults with gastric cancer.

OBJECTIVES: Survival data for young adults (YA) with gastric cancer is conflicting and scarce in Brazil. The aim of this study was to compare the clinicopathological factors and survival rates of younger and older patients with gastric cancer. METHODS: Hospital registries for 294 gastric cancer patients from a reference cancer hospital in São Paulo, Brazil, were consulted for the retrieval of clinicopathological information and follow-up time. Patients were placed into the following groups: YA (≤40 years; N=71), older adult (OA: 41 to 65 years; N=129) and elderly (E: ≥66 years; N=94). Differences were assessed through Pearson's χ2 test, Kaplan-Meier analysis, Log rank test and Cox regression. RESULTS: More YA were diagnosed with advanced disease (clinical stage III/IV: 86.7% YA, 69.9% OA, and 67% E); however, fewer E patients underwent surgery (64.3% YA, 72.7% OA, and 52.4% E). The median overall survival among all patients was 16 months, and the overall survival rate was not significantly different among the age groups (p=0.129). There were no significant differences in the disease-free survival rate. Metastatic disease at diagnosis (HR=4.84; p<0.01) was associated with an increased hazard of death for YA. CONCLUSION: Overall survival was similar among age groups. Metastatic disease at diagnosis was the only factor associated with a poorer prognosis in YA. These results suggest that younger patients deserve special attention regarding the detection of early stage disease.

Survival and prognosis of young adults with gastric cancer

OBJECTIVES: Survival data for young adults (YA) with gastric cancer is conflicting and scarce in Brazil. The aim of this study was to compare the clinicopathological factors and survival rates of younger and older patients with gastric cancer. METHODS: Hospital registries for 294 gastric cancer patients from a reference cancer hospital in São Paulo, Brazil, were consulted for the retrieval of clinicopathological information and follow-up time. Patients were placed into the following groups: YA (≤40 years; N=71), older adult (OA: 41 to 65 years; N=129) and elderly (E: ≥66 years; N=94). Differences were assessed through Pearson's χ2 test, Kaplan-Meier analysis, Log rank test and Cox regression. RESULTS: More YA were diagnosed with advanced disease (clinical stage III/IV: 86.7% YA, 69.9% OA, and 67% E); however, fewer E patients underwent surgery (64.3% YA, 72.7% OA, and 52.4% E). The median overall survival among all patients was 16 months, and the overall survival rate was not significantly different among the age groups (p=0.129). There were no significant differences in the disease-free survival rate. Metastatic disease at diagnosis (HR=4.84; p<0.01) was associated with an increased hazard of death for YA. CONCLUSION: Overall survival was similar among age groups. Metastatic disease at diagnosis was the only factor associated with a poorer prognosis in YA. These results suggest that younger patients deserve special attention regarding the detection of early stage disease.

Genetic anticipation in BRCA1/BRCA2 families after controlling for ascertainment bias and cohort effect.

BACKGROUND: Genetic anticipation, the earlier onset of disease in successive generations, has been reported in hereditary breast and ovarian cancer syndrome (HBOC), but little is known about its underlying mechanisms. Ascertainment bias has been suggested as a reason in previous studies. Likewise, cohort effect, which may be caused by environmental factors, can be misinterpreted as genetic anticipation. METHODS: The authors reviewed the pedigrees of 176 kindreds, segregating those with deleterious mutations in breast cancer genes 1 and 2 (BRCA1/BRCA2) who had at least 2 consecutive generations of the same cancer (breast or ovarian). By using mutation probabilities as analytical weights in weighted random-effect models, generational differences in the age at onset of breast/ovarian cancer were calculated. The analyses were further controlled for ascertainment bias by excluding probands and adjusting for birth-cohort effect in the anticipation models. RESULTS: The mean age at the onset of breast cancer for the probands' generation was 41.9 years, which was 6.8 years and 9.8 years earlier than the parents' and grandparents' generations, respectively. The anticipation effect for breast cancer remained significant after excluding the probands. There was a birth-cohort effect: patients who were born in 1930s and 1940s had breast cancer 5.0 years and 7.6 years earlier than patients who were born before 1920. The difference in breast cancer age of onset across generations was no longer significant after adjusting for birth-cohort effect. CONCLUSIONS: The observed anticipation effect was driven mainly by a decrease in age of onset across birth cohorts, underscoring the need for risk-reducing interventions that target changing environmental/lifestyle factors in BRCA1/BRCA2 carriers. Cancer 2016;122:1913-20. © 2016 American Cancer Society.

Validation of questionnaire on the Spiritual Needs Assessment for Patients (SNAP) questionnaire in Brazilian Portuguese.

OBJECTIVES: Spirituality is related to the care and the quality of life of cancer patients. Thus, it is very important to assess their needs. The objective of this study was the translation and cultural adjustment of the Spiritual Needs Assessment for Patients (SNAP) questionnaire to the Brazilian Portuguese language. METHODOLOGY: The translation and cultural adjustment of the SNAP questionnaire involved six stages: backtranslation, revision of backtranslation, translation to the original language and adjustments, pre-test on ten patients, and test and retest with 30 patients after three weeks. Adult patients, with a solid tumour and literate with a minimum of four years schooling were included. For analysis and consistency we used the calculation of the Cronbach alpha coefficient and the Pearson linear correlation. RESULTS: The final questionnaire had some language and content adjustments compared to the original version in English. The correlation analysis of each item with the total score of the questionnaire showed coefficients above 0.99. The calculation of the Cronbach alpha coefficient was 0.9. The calculation of the Pearson linear correlation with the test and retest of the questionnaire was equal to 0.95. CONCLUSION: The SNAP questionnaire translated into Brazilian Portuguese is adequately reliable and consistent. This instrument allows adequate access to spiritual needs and can help patient care.

Mutation spectrum and risk of colorectal cancer in African American families with Lynch syndrome.

BACKGROUND & AIMS: African Americans (AAs) have the highest incidence of and mortality resulting from colorectal cancer (CRC) in the United States. Few data are available on genetic and nongenetic risk factors for CRC among AAs. Little is known about cancer risks and mutations in mismatch repair (MMR) genes in AAs with the most common inherited CRC condition, Lynch syndrome. We aimed to characterize phenotype, mutation spectrum, and risk of CRC in AAs with Lynch syndrome. METHODS: We performed a retrospective study of AAs with mutations in MMR genes (MLH1, MSH2, MSH6, and PMS2) using databases from 13 US referral centers. We analyzed data on personal and family histories of cancer. Modified segregation analysis conditioned on ascertainment criteria was used to estimate age- and sex-specific CRC cumulative risk, studying members of the mutation-carrying families. RESULTS: We identified 51 AA families with deleterious mutations that disrupt function of the MMR gene product: 31 in MLH1 (61%), 11 in MSH2 (21%), 3 in MSH6 (6%), and 6 in PMS2 (12%); 8 mutations were detected in more than 1 individual, and 11 have not been previously reported. In the 920 members of the 51 families with deleterious mutations, the cumulative risks of CRC at 80 years of age were estimated to be 36.2% (95% confidence interval [CI], 10.5%-83.9%) for men and 29.7% (95% CI, 8.31%-76.1%) for women. CRC risk was significantly higher among individuals with mutations in MLH1 or MSH2 (hazard ratio, 13.9; 95% CI, 3.44-56.5). CONCLUSIONS: We estimate the cumulative risk for CRC in AAs with MMR gene mutations to be similar to that of individuals of European descent with Lynch syndrome. Two-thirds of mutations were found in MLH1, some of which were found in multiple individuals and some that have not been previously reported. Differences in mutation spectrum are likely to reflect the genetic diversity of this population.

Germline mutations in BRCA1, BRCA2, CHEK2 and TP53 in patients at high-risk for HBOC: characterizing a Northeast Brazilian Population.

Considering the importance of BRCA1, BRCA2, CHEK2 and TP53 in the development of hereditary early-onset breast and ovarian cancer and that the genetic susceptibility profile of the Northeast population from Brazil has never been analyzed, this study aimed to verify the frequency of mutations of clinical significance in these genes in high-risk hereditary breast and ovarian cancer (HBOC) syndrome patients from that region. DNA samples from 106 high-risk unrelated patients mostly from Bahia, the biggest state in the Northeast region, were analyzed. These patients underwent full BRCA1 gene sequencing, screening for common founder mutations in the BRCA2, CHEK2 and TP53 genes and genetic ancestry analysis with nine ancestry informative markers. The positive results were confirmed by two sequencing reactions. Three mutations of clinical significance were found: BRCA1 p.R71G (4.71%), 3450del4 (3.77%) and TP53 p.R337H (0.94%). The genetic ancestry analysis showed a high European ancestry contribution (62.2%) as well as considerable African (31.2%) and Amerindian (6.6%) ancestry contributions (r (2)=0.991); this degree of heterogeneity was also significant in the population structure analysis (r=0.604). This population is highly admixed with a different spectrum of genetic susceptibility, with the Galician founder mutation BRCA1 p.R71G accounting for 50% of all identified mutations in high-risk HBOC patients. TP53 p.R337H was also significantly frequent; thus, the combined screening of BRCA1/2 and TP53 should be offered to high-risk HBOC patients from Northeast Brazil.

Should extragonadal germ cell tumors be included in studies of families with testicular germ cell tumors?

BACKGROUND: Family history is among the few established risk factors for testicular germ cell tumor (TGCT). Approximately 1.4% of newly diagnosed TGCT patients report a positive family history of TGCT. Sons and siblings of TGCT patients have four- to six fold and eight- to tenfold increase in TGCT risk, respectively. In twins of men with TGCT the relative risk of testicular cancer is 37.5 (12.3-115.6). Nevertheless, information about the occurrence of TGCT in relatives of patients with extragonadal germ cell tumor is limited. CASE REPORT: A 24 year-old male patient was diagnosed with a mediastinum tumor and was submitted to image-guided biopsy, which revealed a seminoma. Two months later, his non-identical asymptomatic twin brother was submitted to an elective ultrasound of the testes, which showed a left testicular mass of 4.2 cm. This patient underwent orchiectomy revealing a seminoma of the left testis. There are no other cases of seminoma or other types of cancers reported in first-degree relatives in this family. CONCLUSIONS: Although familial aggregations of TGCT have been well described, to the best of our knowledge, no data concerning the association of gonadal and extragonadal germ cell tumor in relatives has been previously reported. Further investigation on this association is warranted and may help in improving our knowledge of familial pattern inheritance.

Valor das provas de posicionamento da ponta da agulha de veress em punção do hipocôndrio esquerdo na instalação do pneumoperitônio / The value of tests results for veress needle tip placement intraperitoneally in the left hypochondrium for creating a pneumoperitoneum

OBJETIVO: Avaliar provas de posicionamento da agulha de Veress no hipocôndrio esquerdo na criação do pneumoperitônio. MÉTODO: Em cem pacientes puncionados no hipocôndrio esquerdo, provas de posicionamento da agulha foram avaliadas, considerando-as positivas quando, na prova da aspiração (PA), material orgânico era aspirado; na prova da resistência (PRes), exercia-se pequena força no êmbolo da seringa à infusão de líquido; na prova da recuperação (PRec), não se recobrava o líquido infundido; na do gotejamento (PG), as gotas escoavam rapidamente e, na prova da pressão intraperitoneal inicial (PPII), os níveis eram = 8mmHg. PA positiva denunciava iatrogenia, enquanto que PRes, PRec, PG e PPII positivas indicavam que a ponta da agulha estava adequadamente posicionada na cavidade peritoneal. Foram calculadas a sensibilidade (S) e a especificidade (E) das provas, e os seus valores preditivos positivos (VPP) e negativos (VPN), mediante correlação dos resultados verdadeiro-positivos (a), falso-positivos (b), falso negativos (c) e verdadeiro-negativos (d), segundo as fórmulas: S=[a/(a+c)]x100; E=[d/(b+d)]x100; VPP=[a/(a+b)]x100; VPN=[d(c+d)]x100. RESULTADOS: Na PA, constatou-se que S e VPP não puderam ser aplicados, e E=100 por cento e VPN=100 por cento. Na PRes, S=0 por cento, E=100 por cento, VPP=não existiu e VPN=90 por cento. Tanto na PRec quanto na PG, S=50 por cento, E=100 por cento, VPP=100 por cento e VPN=94,7 por cento. Na PPII, obteve-se que S, E, VPP e VPN=100 por cento. CONCLUSÕES: Na punção no hipocôndrio esquerdo, PA negativa garante ausência de lesões; a PRes é insegura quanto ao mau posicionamento da agulha, mas indica corretamente o bom; a PRec e a PG não reconhecem bem o adequado posicionamento, mas detectam com segurança o inadequado; a PPII acusa com segurança tanto o mau quanto o bom posicionamento da agulha, sendo a prova mais confiável dentre as estudadas.

BACKGROUND: To evaluate tests for Veress needle tip placement intraperitoneally in the left hypochondrium for creating a pneumoperitoneum. METHODS: Needle tip placement tests were evaluated in one hundred patients using the left hypochondrium area. It was considered positive when: aspiration test (PA) -returned organic material; resistance test (PRes) - a low pressure was pushed on the syringe for the liquid infusion; recovery test (PRec) - no liquid was recovered after infusion; dripping test (PG) - drops drained quickly; test for initial intraperitoneal pressure (PPII) - levels were <= 8mmHg. Positive PA suggested bowel injury, while positive PRes, PRec, PG and PPII indicated that needle tip was adequately located in the peritoneal cavity. The Sensitivity ( SE) and Specificity ( SP ), as well as their predictive positive values (PPV) and predictive negative values ( PNV) of these tests were calculated using results correlation which were true-positives (a), false-positives (b), false-negatives (c) and true-negatives (d), accordingly to the formulas: SE =[a/ (a+c)]x100; SP =[d/(b+d)]x100; PPV=[a/(a+b)]x100; PNV=[d(c+d)]x100. RESULTS: If a positive PA had returned, SE and PPV did not fit, and SP=100 percent and PNV =100 percent. In the PRes, SE =0 percent, SP =100 percent, PPV = did not exist and PNV =90 percent. Both in the PRec and in the PG, results were for SE =50 percent, SP =100 percent, PPV =100 percent and PNV =94.7 percent. In the PPII test results were for SE, PPV and PNV =100 percent. CONCLUSION: Left hypochondrium negative PA guaranteed that bowel was not perforated; PRes test is a not accurate test for detection of the needle tip bad placement, however it accurately indicates its good positioning; PRec and the PG tests do not detect the adequate positioning, but they detect very well the inadequate positioning; PPII test shows with reliability both bad and good positioning of the needle, being the most trustworthy test among...

Veress needle insertion in the left hypochondrium in creation of the pneumoperitoneum / Punção no hipocôndrio esquerdo com agulha de Veress para a criação do pneumoperitônio

PURPOSE: To test the efficacy of the puncture in the left hypochondrium as an alternative method. METHODS: Sixty-two patients randomly distributed into two groups were studied: Group LH, puncture in the left hypochondrium (n=30), and Group ML, puncture in the abdominal midline (n=32). The following were assessed: needle positioning tests, number of failed attempts at needle insertion, and time needed for creation of pneumoperitoneum. Gas flow, volume and intraperitoneal pressure were recorded at every 20 seconds, until a 12 mmHg pressure was reached inside the peritoneal cavity. RESULTS: A similar number of positive results for the needle positioning tests were observed in both groups. Two failed attempts to reach the peritoneal cavity were observed in Group ML and one in Group LH. The time necessary for the creation of pneumoperitoneum was on average 3 minutes and 46 seconds for Group LH, and 4 minutes and 2 seconds for Group ML. Average gas flow, volume and pressure were equivalent for both groups. CONCLUSION: Puncture in the left hypochondrium was as effective as puncture in the abdominal midline for the creation of pneumoperitoneum.

OBJETIVO: Avaliar a eficácia e segurança da punção alternativa no hipocôndrio esquerdo. MÉTODOS: Sessenta e dois pacientes distribuídos aleatoriamente em dois grupos foram estudados prospectivamente: grupo HE, punção no hipocôndrio esquerdo (n=30) e grupo LM, punção na linha média do abdome (n=32). Foram avaliados os testes de posicionamento da agulha, o número de tentativas frustradas e a duração da instalação do pneumoperitônio. Os fluxos correntes, as pressões intraperitoneais e os volumes injetados foram registrados a cada 20 segundos, até 12 mmHg. RESULTADOS: O número de resultados positivos aos testes de posicionamento da agulha foi semelhante em ambos os grupos. Ocorreram duas tentativas infrutíferas de punção no grupo LM e uma no grupo HE. O tempo necessário para o estabelecimento do pneumoperitônio foi, em média, 3 minutos e 46 segundos para o Grupo HE e 4 minutos e 2 segundos para o grupo LM. As médias dos fluxos, das pressões e dos volumes foram respectivamente equivalentes entre os grupos.. CONCLUSÃO: A punção no HE foi tão eficaz no estabelecimento do pneumoperitônio quanto a punção na LM do abdome.

Veress needle insertion in the left hypochondrium in creation of the pneumoperitoneum.

PURPOSE: To test the efficacy of the puncture in the left hypochondrium as an alternative method. METHODS: Sixty-two patients randomly distributed into two groups were studied: Group LH, puncture in the left hypochondrium (n=30), and Group ML, puncture in the abdominal midline (n=32). The following were assessed: needle positioning tests, number of failed attempts at needle insertion, and time needed for creation of pneumoperitoneum. Gas flow, volume and intraperitoneal pressure were recorded at every 20 seconds, until a 12 mmHg pressure was reached inside the peritoneal cavity. RESULTS: A similar number of positive results for the needle positioning tests were observed in both groups. Two failed attempts to reach the peritoneal cavity were observed in Group ML and one in Group LH. The time necessary for the creation of pneumoperitoneum was on average 3 minutes and 46 seconds for Group LH, and 4 minutes and 2 seconds for Group ML. Average gas flow, volume and pressure were equivalent for both groups. CONCLUSION: Puncture in the left hypochondrium was as effective as puncture in the abdominal midline for the creation of pneumoperitoneum.

Parâmetros eficientes do posicionamento adequado da ponta da agulha de veress durante o estabelecimento de pneumoperitônio / Reliable guidelines for adequate positioning of veress needle on the stablishment of the pneumoperitoneum

OBJETIVO: Avaliar a possibilidade do estabelecimento de parâmetros fidedignos do adequado posicionamento da ponta da agulha de Veress no interior da cavidade peritoneal durante o estabelecimento do pneumoperitônio. MÉTODO: Em 100 pacientes selecionados a ponta da agulha de Veress foi introduzida na cavidade peritoneal e o insuflador foi programado para fluxo de 1,2L/min e pressão máxima final para 12mmHg. No início da insuflação e a cada 20 segundos a pressão intraperitoneal (PI) e o total do volume injetado até aquele momento (TVI) eram registrados. Os dados foram tratados por correlações estatísticas entre momentos e PI, e momentos e TVI. Também foi estabelecida a previsão dos valores de PI e TVI no final de cada um dos quatro primeiros minutos de insulflação, utilizando-se os modelo estimados: PI = 2,3083 + 0,0266 x tempo + 8,3x10-5 x tempo³ - 2,44x10-7 x tempo³ ; TVI = 0,813 + 0,0157 x tempo. RESULTADOS: A PI e o TVI mostraram correlação entre momentos pré-estabelecidos da criação do pneumoperitônio, sendo constatado um ajuste forte: PI = -2E - 07 x tempo³ + 8E - 05 x tempo² + 0,0266 x tempo + 2,3083, com coeficiente de explicação (R2) = 0,8011; TVI = 0,0157 x tempo + 0,1813, com R2 = 0,9604. A previsão de PI e TVI mostrou: PI(mmHg): 1min=4,15; 2min=6,27; 3min=8,36; 4min=10,10 e TVI(L): 1min=1,12; 2min=2,07; 3min=3,01; 4min=3,95. CONCLUSÕES: Parâmetros fidedignos para PI e TVI , quando a ponta da agullha de Veress se encontra na cavidade peritoneal, em dados momentos da insuflação podem ser estabelecidos durante a criação do penumoperitônio.

BACKGROUND: To evaluate the possibility of establishing reliable parameters for the appropriate positioning of Veress needle tip in the peritoneal cavity during pneumoperitoneum creation. METHODS: In 100 selected patients Veress needle tip were introduced in the peritoneal cavity and the insufflators were programmed for a flow of 1,2L/min and with final maximum pressure of 12mmHg. At the beginning of the insufflation and at every 20 seconds the intraperitoneal pressure (IP) and the total volume injected (TVI) were recorded. Data was treated by statistical correlation between moments and IP, and moments and TVI. The forecast values of IP and TVI at the end of each one of the four first insufflation minutes were also established, using the following estimated formulas: IP = 2.3083 + 0.0266 x time + 8.3x10-5 x time³ - 2.44x10-7 x time³; TVI = 0.813 + 0.0157 x time. RESULTS: IP and TVI showed a correlation between pre-established moments of pneumoperitoneum creation when a strong adjustment became apparent: IP = -2E - 07 x time³ + 8E - 05 x time² + 0.0266 x time + 2.3083, with a coefficient of explanation: (R2) = 0.8011; TVI = 0.0157 x time + 0.1813, with R2=0.9604. The forecast of IP and TVI showed: IP (mmHg): 1min=4.15; 2 min=6.27; 3 min=8.36; 4 min=10.10 and TVI (L): 1min=1.12; 2 min=2.07; 3 min=3.01; 4 min=3.95. CONCLUSION: Reliable parameters for IP and TVI can be established during pneumoperitoneum creation when the Veress needle tip is located in the peritoneal cavity in a given insufflation moment.