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Objective: Sentinel lymph node (SLN) biopsy has been increasingly used in the management of early-stage cervical cancer. It appears in guidelines as an alternative option to systematic pelvic lymphadenectomy. The evidence about safety is, however, based mostly on retrospective studies, in which SLN was combined with systematic lymphadenectomy. Materials and methods: SENTIX is a prospective multicenter trial aiming to prove that less-radical surgery with SLN is non-inferior to treatment with systematic pelvic lymphadenectomy. The primary end point is recurrence rate; the secondary end point is the prevalence of lower-leg lymphedema and symptomatic pelvic lymphocele. The reference recurrence rate was set up conservatively at 7% at 24 months after treatment. With a sample size of 300 patients treated per protocol, the trial is powered to detect a non-inferiority margin of 5% (90% power, p = 0.05) for recurrence rate, 30% reduction in the prevalence of symptomatic lymphocele or lower-leg lymphedema, with reference rates of 30% and 6% at 12 months (p = 0.025, Bonferroni correction). The patients eligible for SENTIX have stage IA1/LVSI+, IA2, IB1 (<2 cm for fertility sparing), with negative LN on pre-operative imaging. Intra-operatively, patients are excluded when there is a failure to detect SLN on both sides of the pelvis in cases of more advanced cancer (stage >IB1), or a positive intra-operative SLN assessment. The quality of SLN pathology evaluation will be assessed by central review. Three interim safety analyses are pre-planned when 30, 60, 150 patients complete 12 months' follow-up. Conclusions: The first patient was enrolled into the study in June 2016 and, by June 2018, 340 patients had been enrolled. The first analysis of secondary outcomes should be available in 2019 and the oncological outcome of 300 patients at the end of 2021. The trial is registered as a CEEGOG trial (CEEGOG CX-01), ENGOT trial (ENGOT-Cx 2), and at the ClinicalTrials.gov database (NCT02494063). [ABSTRACT FROM AUTHOR]

Supplemental digital content is available in the text. Objective: It is difficult to critically outline the optimal treatment for women with early-stage cervical cancer (eCC) wishing fertility preservation. Neoadjuvant chemotherapy (NAC) to downstage “bulky” eCC could potentially lead to fertility-sparing surgery (FSS) in a wider patient population. The rationale is to provide oncological safety balanced with maximal fertility effort. We aimed to obtain the most accurate fertility outcomes for eCC women treated with NAC followed by FSS and identify potential factors favoring fertility. Methods: A systematic search of MEDLINE, EMBASE, Web of Science, and Cochrane Database was performed. Studies that reported obstetric outcomes of eCC women treated with NAC followed by FSS were located. For the meta-analysis, we calculated the proportions of women who had the outcomes per total number of women who were considered for FSS. For the meta-regression, we extracted the relative risk of the outcome variables to enable comparison of the results across the studies. Results: Seven studies enrolling 86 patients were included in the meta-analysis. Pooling of results from seven studies rendered summary proportions of 0.49 (95% confidence interval [CI], 0.32–0.66) and 0.42 (95% CI, 0.32–0.53) for the outcomes of pregnancies and live births, respectively. The outcome of first- and second-trimester losses by pooling seven studies rendered a summary proportion of 0.16 (95% CI, 0.09–0.27). For the outcome of premature deliveries, pooling of results from five studies rendered a summary proportion of 0.06 (95% CI, 0.02–0.16). This reached 0.29 (95% CI, 0.15–0.48) in women who achieved live births. In multivariate meta-regression, the more radical surgical approach resulted in a less favorable pregnancy rate compared with the less radical surgical approach (P = 0.015). Conclusions: This strategy achieves live births in four of 10 eCC women who desire fertility, whereas their risk of miscarriage is low. Three of 10 live births will be premature. [ABSTRACT FROM AUTHOR]

Background and Objectives: The aim of this study was to compare the feasibility, morbidity, and recurrence rate of total laparoscopic radical hysterectomy (LRH) with those of abdominal radical hysterectomy (ARH) for bulky early-stage cervical cancer. Methods: We performed a retrospective cohort study of 112 patients with stage IB1 or IIA2 cervical cancer in which the tumor diameter was 3 cm or greater. All patients underwent LRH (n = 30) or ARH (n = 82) with pelvic lymphadenectomy and/or para-aortic lymph node sampling between May 2011 and November 2014. Perioperative outcomes were compared between the 2 surgical groups. Results: The laparoscopic approach consisted of 4 trocar insertions. Age, tumor diameter, and pelvic lymph nodes significantly differed between the 2 cohorts. Body mass index, International Federation of Gynecology and Obstetrics stage, histologic type and grade, deep stromal invasion, lymphovascular space invasion, positive margins, and adjuvant therapy were not significantly different between the 2 cohorts. Laparoscopic radical hysterectomy exhibited favorable results compared with ARH in terms of operating time, blood loss, intestinal exhaust time, and length of hospital stay. In addition, recurrence was observed in 5 LRH patients (16.7%) and 9 ARH patients (11.7%). Conclusions: The surgical outcomes of LRH with pelvic lymphadenectomy and/or para-aortic lymph node sampling exhibited a similar therapeutic efficacy to those of the ARH approach. [ABSTRACT FROM AUTHOR]

Objective: In early-stage cervical cancer, single modality therapy is the main objective, to minimize patient morbidity while offering equivalent cure rates. Intraoperative frozen section examination (FSE) of lymph nodes (LNs) can facilitate this aim, ensuring that radical surgery is avoided in patients requiring adjuvant therapy for metastatic LN involvement. We aimed to evaluate the accuracy of routine intraoperative FSE of pelvic LNs during the surgical staging of early-stage cervical cancers and identify a group at low risk for nodal metastases. Methods: A retrospective cohort study of 94 women aged 23 to 80 years who underwent primary surgery and planned intraoperative FSE of the pelvic LNs at the gynecological cancer center in Oxford was performed. The diagnostic value of FSE and the prediction of metastatic nodal disease were assessed by use of preoperative and intraoperative variables. Results: A total of 1825 LNs were submitted for FSE. Of 94 women (13.8%), 13 had positive LNs at FSE. Two false-negative cases were reported with micrometastases but no false-positive cases. Frozen section examination as a diagnostic test reached a sensitivity of 86.7% and a specificity of 100%. A regression model including grade I to II and tumor size of less than 20 mm identified a low-risk group for LN involvement. Conclusions: In light of diverse practice patterns, FSE should be routinely offered to women with early-stage cervical cancer in a 1-step protocol. We equally devised a model to predict those patients at least risk of nodal disease, who may be spared of FSE. [ABSTRACT FROM AUTHOR]

The aims of this study were to predict pelvic lymph node metastasis in uterine cervical cancer before surgery and to evaluate the potential efficacy of omitting pelvic lymphadenectomy.A total of 163 patients with invasive uterine cervical cancer in FIGO stage IA2 to IIB, all of whom underwent primary radical hysterectomy with pelvic lymphadenectomy, participated in this study.The incidences of pelvic lymph node metastasis in stage IA2, stage IB1, stage IB2, stage IIA, and stage IIB cervical cancer were 0% (0/12), 17% (13/76), 22% (6/27), 33% (8/24), and 63% (15/24), respectively. A significant difference was observed in overall survival with nodal metastasis status (P < 0.0001). Univariate analysis revealed that parametrial invasion (P < 0.0001), tumor markers (P = 0.0006), tumor size greater than 2 cm (P < 0.0001), tumor size less than 3 cm (P = 0.0009), and tumor size greater than 4 cm (P = 0.0024) were correlated with pelvic lymph node metastasis. However, multivariate analysis revealed that parametrial invasion (P = 0.01; odds ratio, 3.37; 95% confidence interval, 1.31-9.0) and tumor size greater than 2 cm (P = 0.005; odds ratio, 4.93; 95% confidence interval, 1.54-22.01) were independently associated with nodal metastasis.Pelvic lymphadenectomy may be avoided in patients with negative parametrial invasion and a tumor size less than 2 cm, thereby minimizing postoperative complications. [ABSTRACT FROM AUTHOR]

Lymphoceles are among the most common postoperative complications of pelvic lymphadenectomy (PL), with a reported incidence of 1% to 50%. Symptoms are pelvic pain, leg edema, gastrointestinal obstruction, obstructive uropathy, and deep vein thrombosis, and severe complications such as sepsis and lymphatic fistula formation. After laparoscopic PL, we tested the prevention of lymphoceles using collagen patch coated with the human coagulation factors (TachoSil, Nycomed International Management GmbH, Zurich, Switzerland) on 55 patients with endometrial cancer stages IB to II who had undergone laparoscopy.The authors divided the patients into 2 laparoscopy groups: PL plus TachoSil (group 1: 26 patients) and PL without TachoSil in a control group (group 2: 29 patients), as historical cohort of patients who underwent PL between 2010 and 2012. We collected surgical parameters, and the patients underwent ultrasound examination on postoperative days 7, 14, and 28. The main outcome measures were the development of symptomatic or asymptomatic lymphoceles, the need for further surgical intervention, as adverse effect of surgery, and the drainage volume and duration.The same number of lymph nodes in both groups was removed; group 1 showed a lower drainage volume. Lymphoceles developed in 5 patients in group 1 and in 15 patients in group 2; of these, only 2 patients were symptomatic in group 1 and 5 patients were symptomatic in group 2, without statistical difference and no percutaneous drainage request.In this preliminary investigation, the intraoperative laparoscopy application of TachoSil seems to reduce the rate of postoperative lymphoceles after PL, providing a useful additional treatment option for reducing drainage volume and preventing lymphocele development after PL. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the ratio of metastatic and removed lymph nodes (RPL) and the number of metastatic lymph nodes (MLNs) in predicting postoperative survival for International Federation of Gynecology and Obstetrics stage IA2 to IIA cervical cancer after radical hysterectomy and pelvic lymphadenectomy (RHPL).A retrospective study was conducted in which 120 patients with lymph node metastasis who underwent RHPL for cervical cancer from 2000 to 2006 was analyzed to identify the prognostic indicators by using Kaplan-Meier and Cox proportional hazard methods.Of 588 patients with cervical cancer who underwent RHPL, the 5-year survival rate (YSR) of 120 with lymph node metastasis was much lower than that of 468 without lymph node metastasis (22.4% vs 84.4%, P < 0.001). By cut-point survival analysis, RPL cutoff was designed as 10%, with the 5-YSR of 42.9% and 11.8%, and MLN count cutoffs were designed as 1 and 5, with the 5-YSR of 62.5%, 20.8%, and 7.8%, respectively. With univariate analysis, increasing RPL and MLN counts were associated with a poorer survival in women with node metastasis cervical cancers. Stage, histologic grade, RPL, and MLN count were significant independent prognostic factors for survival in a multivariate Cox proportional hazard model. In addition, RPL was verified superior to MLN count in prognostic evaluation for patients with IA2 to IIA cervical cancer after RHPL because the hazard ratio of RPL (3.195) was higher than that of MLN count (1.578).The RPL and MLN count may be used as the independent prognostic parameters in patients with cervical cancer with lymph node metastasis after RHPL. Comparison of the superiority of RPL and MLN count for better predicting the survival of patients with cervical cancer deserves to be investigated further. [ABSTRACT FROM AUTHOR]

To determine the clinical effect of nonperitonization and laparoscopic lymphadenectomy using bipolar electrocautery after radical hysterectomy for cervical cancer compared with peritonization and open lymphadenectomy using monopolar electrocautery.This was a retrospective study of 180 patients who underwent a radical hysterectomy and pelvic lymph node dissection (PLND) for cervical cancer from August 1998 to August 2007. The patients were composed of the Peritonization + Laparotomy group (group A; n = 98, 196 PLND) and the Nonperitonization + Laparoscopy group (group B; n = 82, 164 PLND). Group B left the peritoneum in front of the PLND open. Two closed-suction drains were placed at each side of the PLND.Group B statistically showed a lesser total amount of lymphatic drainage (P = 0.001), shorter duration of inserted drains (P < 0.001), and shorter length of hospital stay (P < 0.001), compared with group A. The formation of lymphocysts occurred in 30 patients (41 lymphocysts) of group A and 5 patients (5 lymphocysts) of group B. Lymphocyst formation of group B had a statistically lower incidence than that of group A (P < 0.001). Lymphocyst formation was associated with an increase in the total amount of lymphatic drainage in group A (P = 0.090) and group B (P = 0.041) and a pathologic type of adenocarcinoma in group B (P = 0.016). Surgical experiences were not correlated with lymphocyst formation.The omission of peritonization and laparoscopic lymphadenectomy using bipolar electrocautery in early-stage cervical cancer were more effective than peritonization and open lymphadenectomy using monopolar electrocautery in minimizing the incidence of lymphocyst formation. [ABSTRACT FROM AUTHOR]

The current guidance for the management of women with stage IA2 cervical carcinoma is that whatever the primary surgical intervention, pelvic lymphadenectomy should be included. The role of lymphadenectomy in the management of cervical carcinoma remains somewhat confused, as the procedure has not been proven to be therapeutic, although it is claimed that the information gained is valuable in determining the need for adjuvant therapy.For lymphadenectomy to have clinical utility in the care of women with stage IA2 cervical carcinoma, a sufficiently high incidence of node positivity would be required to justify the morbidity of the procedure for the whole group.The objective of this paper was to establish the incidence of pelvic lymph node positivity in stage IA2 cervical carcinoma.A PubMed search using the words "stage IA2 cervical carcinoma," "microinvasive cervical carcinoma," "stage IA cervical carcinoma," "stage I cervical carcinoma," and "lymphadenectomy in cervical carcinoma" was performed; the articles were divided into those that adhered to the International Federation of Gynecology and Obstetrics (FIGO) definition of a stage IA2 tumor and those that did not. Sentinel node studies were not included, as this procedure does not form part of the FIGO guidelines.Studies adhering to the FIGO definition showed a 0.5% incidence of lymph node metastases in stage IA2 cervical carcinomas, which is not as high as was previously believed (7.3%).The very low rate of positive lymph nodes in correctly staged IA2 cases cannot justify the inclusion of lymphadenectomy as part of standardized care for these patients. [ABSTRACT FROM AUTHOR]

Of 284 patients evaluated for entry into the study between January 1986 and June 1990, systematic para-aortic and pelvic lymphadenectomy was performed in 208 cases (108 cervical cancer, 43 and 57 ovarian and endometrial cancer, respectively). The median number of nodes removed was 58, 49 and 54 for cervical, ovarian and endometrial cancer, respectively. The operating data are divided into 2 groups according to the consecutive number of the cases. The median operating time and the median estimated blood loss of lymphadenectomy was 230 minutes (range 120-270) and 390 ml (range 200-3300) in the first 95 cases. These operating data decreased to 150 minutes (range 100-240) and 250 ml (range 100-2800) in the second 113 cases. No surgery-related deaths occurred. Severe hemor-rages (blood loss exceeding 1000 ml) occurred in 6 patients. The obturator nerve was dissected in 1 patient and in 1 case the left ureter was cut. Formation of lymphoceles occurred in 20.4% of patients. Eighteen patients (8.8%) developed deep venous thrombosis. Nine of these patients experienced pulmonary microembolism. In 3 patients a retroperitoneal abscess was diagnosed. One patient developed a fistula of the most proximal part of the right ureter during the third postoperative week. The resection or coagulation of branches of the genito-femoral and obturator nerves determined mild paresthesis localized at the supero-anterior and internal side of thigh in 11 cases (5.4%). No statistically significant differences were found between the clinical (age, weight and previous chemotherapy) and pathological (type of cancer and lymph node status) parameters considered on one hand and postoperative complications on the other. [ABSTRACT FROM AUTHOR]

Whether the size of a retroperitoneal lymph node reflects its status is not clear. We measured the size of 125 positive and 160 negative pelvic lymph nodes in 32 consecutive patients with node-positive endometrial cancer. The measurements were compared with those of 143 pelvic lymph nodes of five randomly selected patients with endometrial cancer without node involvement. Overall, positive lymph nodes were larger than negative lymph nodes in both node-positive patients and node-negative controls (P<0.01). There was a positive correlation between the size of positive lymph nodes and the size of the metastasis therein (P<0.01). However, 68 of 125(54%) positive lymph nodes measured less than 10 mm in maximum diameter, while 46 of 160 (29%) negative lymph nodes in node-positive patients measured more than 10 mm in maximum diameter. The metastasis was detected in more than 50% of step-serial sections in only 74% of positive lymph nodes. These data suggest that the size of a lymph node does not reliably reflect its status. Thus, these nodes may be missed if only enlarged nodes are removed. If only one section of a lymph node is performed, at least 26% of metastases will be missed. [ABSTRACT FROM AUTHOR]