Superparamagnetic iron oxide (SPIO) for sentinel lymph node detection in vulvar cancer.

OBJECTIVES: Sentinel lymph node (SLN) detection with superparamagnetic iron oxide (SPIO) nanoparticles has been widely studied and standardized for breast and prostate cancer, but there is scarce evidence concerning its use in vulvar cancer. The objective of this study was to compare SLN detection using a SPIO tracer injected at the time of the surgery detected by a magnetometer, with the standard procedure of using a technetium 99 radioisotope (Tc99) detected by a gamma probe, in patients with vulvar cancer. METHODS: The SPIO vulvar cancer study was a single-center prospective interventional non-inferiority study of SPIO compared to Tc99, conducted between 2016 and 2021 in patients who met the GROINSS-V study inclusion criteria for selective sentinel lymph node dissection in vulvar cancer. RESULTS: We included 18 patients and a total of 41 SLNs. The level of agreement between tracers was 92.7% (80.6%-97.4%), corresponding to 38 out of 41 SLNs, which confirms the non-inferiority of SPIO compared to Tc99. The SLN detection rate per groin was 96.3 (81.7%-99.3) using Tc99 and 100% (87.5%-100%) using SPIO. Both tracers had a detection rate of 100% for positive lymph nodes. CONCLUSIONS: The use of SPIO as a tracer for detecting SLNs in patients with vulvar cancer has shown to be non-inferior to that of the standard radiotracer, with the advantages of not requiring nuclear medicine and being able to inject it at the time of surgery after induction of anesthesia.

Survival in pregnancy-associated breast cancer patients compared to non-pregnant controls.

BACKGROUND: Pregnancy-associated breast cancer (PABC) is a rare entity whose prognosis has previously been studied and is subject to controversy. METHODS: Survival of patients with PABC diagnosed between 2009 and 2021 with breast cancer during pregnancy or until 1 year after childbirth was compared with non-pregnant patients with breast cancer from the same period at La Paz University Hospital. Cox proportional hazards regression was used to compare disease-free (DFS) and overall (OS) survival between the groups, adjusting for grade and pathologic stage. RESULTS: Among the 89 included patients with breast cancer, 34 were diagnosed during pregnancy, and 55 were not pregnant. The pregnant patients were more likely to have grade 3 tumors (61.3% vs 37%, p = 0.023) and an advanced stage (pathologic stage III-IV: 44.1% vs 17.6%, p = 0.008). Median follow-up was 47 months for the pregnant group and 46 months for the control group. After adjustments for tumor grade and pathologic stage, OS was comparable between the groups (HR 2.03; 95% CI 0.61 to 6.79; P = 0.25). CONCLUSIONS: The outcome of women diagnosed with PABC is comparable to young non-pregnant controls. However, it should be taken into account that PABC has a more aggressive phenotype.

Progenitor Cell Sources for 3D Bioprinting of Lymphatic Vessels and Potential Clinical Application.

The lymphatic system maintains tissue fluid homeostasis and it is involved in the transport of nutrients and immunosurveillance. It also plays a pivotal role in both pathological and regenerative processes. Lymphatic development in the embryo occurs by polarization and proliferation of lymphatic endothelial cells from the lymph sacs, that is, lymphangiogenesis. Alternatively, lymphvasculogenesis further contributes to the formation of lymphatic vessels. In adult tissues, lymphatic formation rarely occurs under physiological conditions, being restricted to pathological processes. In lymphvasculogenesis, progenitor cells seem to be a source of lymphatic vessels. Indeed, mesenchymal stem cells, adipose stem cells, endothelial progenitor cells, and colony-forming endothelial cells are able to promote lymphatic regeneration by different mechanisms, such as direct differentiation and paracrine effects. In this review, we summarize what is known on the diverse stem/progenitor cell niches available for the lymphatic system, emphasizing the potential that these cells hold for lymphatic tissue engineering through 3D bioprinting and their translation to clinical application.

Aortic sentinel node detection in endometrial cancer: 6 year prospective study.

OBJECTIVE: The aim of this study was to describe our final results using dual cervical and fundal indocyanine green injection for the detection of sentinel lymph nodes (SLNs) in endometrial cancer along parametrial and infundibular drainage pathways. METHODS: We conducted a prospective observational study between 26 June 2014 and 31 December 2020 enrolling 332 patients that underwent laparoscopic surgery for endometrial cancer at our hospital. In all cases, we performed SLN biopsy with dual cervical and fundal indocyanine green injection identifying pelvic and aortic SLNs. All SLNs were processed with an ultrastaging technique. A total of 172 patients also underwent total pelvic and para-aortic lymphadenectomy. RESULTS: The detection rates were as follows: 94.0% overall for SLNs; 91.3% overall for pelvic SLNs; 70.5% for bilateral SLNs; 68.1% for para-aortic SLNs, and 3.0% for isolated paraaortic SLNs. We found lymph node involvement in 56 (16.9%) cases, macrometastasis in 22, micrometastasis in 12 and isolated tumor cells in 22. Fourteen patients had isolated aortic nodal involvement, representing 25% of the positive cases. There was one false negative (SLN biopsy negative but lymphadenectomy positive). Applying the SLN algorithm, the sensitivity of the dual injection technique for SLN detection was 98.3% (95% CI 91-99.7), specificity 100% (95% CI 98.5-100), negative predictive value 99.6% (95% CI 97.8-99.9), and positive predictive value 100% (95% CI 93.8-100). Overall survival at 60 months was 91.35%, with no differences between patients with negative nodes, isolated tumor cells and treated nodal micrometastasis. CONCLUSIONS: Dual sentinel node injection is a feasible technique that achieves adequate detection rates. Additionally, this technique allows a high rate of aortic detection, identifying a non-negligible percentage of isolated aortic metastases. Aortic metastases in endometrial cancer account for as many as a quarter of the positive cases and should be considered, especially in high-risk patients.

Photonic Technology for In Vivo Monitoring of Hypoxia-Ischemia.

Surveillance of physiological parameters of newborns during delivery triggers medical decision-making, can rescue life and health, and helps avoid unnecessary cesareans. Here, the development of a photonic technology for monitoring perinatal asphyxia is presented and validated in vivo in a preclinical stage. Contrary to state of the art, the technology provides continuous data in real-time in a non-invasive manner. Moreover, the technology does not rely on a single parameter as pH or lactate, instead monitors changes of the entirety of physiological parameters accessible by Raman spectroscopy. By a fiber-coupled Raman probe that is in controlled contact with the skin of the subject, near-infrared Raman spectra are measured and analyzed by machine learning algorithms to develop classification models. As a performance benchmarking, various hybrid and non-hybrid classifiers are tested. In an asphyxia model in newborn pigs, more than 1000 Raman spectra are acquired at three different clinical phases-basal condition, hypoxia-ischemia, and post-hypoxia-ischemia stage. In this preclinical proof-of-concept study, figures of merit reach 90% levels for classifying the clinical phases and demonstrate the power of the technology as an innovative medical tool for diagnosing a perinatal adverse outcome.

Transperitoneal vs extraperitoneal approach for aortic sentinel node detection in endometrial cancer.

BACKGROUND: Although the sentinel lymph node technique in endometrial cancer is currently replacing pelvic and aortic lymphadenectomy for the evaluation of lymph node status in endometrial cancer, its performance is not yet standardized. OBJECTIVE: This study aimed to describe the detection rates and locations of aortic sentinel lymph node detection after dual cervical and fundal indocyanine green injection in patients with endometrial cancer, using the transperitoneal and extraperitoneal approaches. STUDY DESIGN: Between June 26, 2014 and December 31, 2019, 278 patients underwent laparoscopic surgery for endometrial cancer at our institution. In all cases, we performed sentinel lymph node biopsy with dual cervical and fundal indocyanine green injection, and back-up lymphadenectomy in high-risk cases. A post hoc analysis was performed to evaluate differences between the transperitoneal and extraperitoneal approach to aortic sentinel lymph nodes. RESULTS: The detection rates were as follows: overall detection rate: 93.2% (259/278); pelvic detection rate: 90.3% (251/278); bilateral pelvic detection rate: 68.0% (189/278); aortic detection rate: 66.9% (186/278); and isolated aortic detection rate: 2.88% (8/278). Transperitoneal and extraperitoneal aortic detection rates were similar (65.0% and 69.6%, respectively), with no significant differences (P=.441). Isolated aortic metastases were similar in both groups (2% vs 4.7%, respectively; P=.185). The laterality of aortic sentinel lymph node detection was influenced by the surgical approach (P=.002), but not its location above or below the inferior mesenteric artery (P=.166 and P=.556, respectively). CONCLUSION: The detection rates at the aortic level were similar between the transperitoneal and extraperitoneal approaches, with no impact on subsequent pelvic detection. The transperitoneal approach detected more laterocaval, precaval, and interaortocaval nodes, whereas the extraperitoneal approach detected more preaortic and left lateroaortic nodes.

Identification of Hypoxia-Ischemia by Chemometrics Considering Systemic Changes of Physiology.

Perinatal asphyxia represents a major medical disorder and is related to around a fourth of all neonatal deaths worldwide. Specific thresholds for lactate or pH levels define the gold standard for detecting hypoxic-ischemic events as physiological abnormalities. In contrast to current gold standard, we analyze the systemic picture, represented by the whole set of biochemical parameters from blood gas analysis, by multiparametric machine learning algorithms. In a swine model with 22 objects, we investigate the impact of neonatal hypoxic-ischemic encephalopathy on 18 individual physiological parameters. In a first approach, we study the statistical significance of individual parameters by univariate analysis methods. In a second approach, we take the most relevant parameters as input for the development of predictive models by different hybrid and non-hybrid classification algorithms. The predictive power of our multiparametric models outperforms by far the limited performance of pH and lactate as reliable indicators, despite strong correlation with hypoxic-ischemic events. We have been able to detect hypoxic-ischemic events even one hour after the episode, with accuracies close to 100% in contrast to pH or lactate-based diagnosis with 62% and 78%, respectively. By all machine learning algorithms, lactate is recognized as the main contributor due to its longer-term evidence of hypoxia-ischemia episodes. However, substantial improvement of the diagnosis is achieved by predictions based on a systemic picture of different physiological parameters. Our results prove the potential applicability of our method as a support tool for decision-making that will allow obstetricians to identify hypoxic-ischemic episodes more accurately during labor.

Cell therapy as a treatment of secondary lymphedema: a systematic review and meta-analysis.

BACKGROUND: Lymphedema, the accumulation of interstitial fluid caused by poor lymphatic drainage, is a progressive and permanent disease with no curative treatment. Several studies have evaluated cell-based therapies in secondary lymphedema, but no meta-analysis has been performed to assess their efficacy. METHODS: We conducted a systematic review and meta-analysis of all available preclinical and clinical studies, with assessment of their quality and risk of bias. RESULTS: A total of 20 articles using diverse cell types were selected for analysis, including six clinical trials and 14 pre-clinical studies in three species. The meta-analysis showed a positive effect of cell-based therapies on relevant disease outcomes (quantification of edema, density of lymphatic capillaries, evaluation of the lymphatic flow, and tissue fibrosis). No significant publication bias was observed. CONCLUSION: Cell-based therapies have the potential to improve secondary lymphedema. The underlying mechanisms remain unclear. Due to relevant heterogeneity between studies, further randomized controlled and blinded studies are required to substantiate the use of these novel therapies in clinical practice.

One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA).

The objective of this study was to evaluate the efficacy of one-step nucleic acid amplification (OSNA) for the detection of sentinel lymph node (SLN) metastasis compared to standard pathological ultrastaging in patients with early-stage endometrial cancer (EC). A total of 526 SLNs from 191 patients with EC were included in the study, and 379 SLNs (147 patients) were evaluated by both methods, OSNA and standard pathological ultrastaging. The central 1 mm portion of each lymph node was subjected to semi-serial sectioning at 200 µm intervals and examined by hematoxylin-eosin and immunohistochemistry with CK19; the remaining tissue was analyzed by OSNA for CK19 mRNA. The OSNA assay detected metastases in 19.7% of patients (14.9% micrometastasis and 4.8% macrometastasis), whereas pathological ultrastaging detected metastasis in 8.8% of patients (3.4% micrometastasis and 5.4% macrometastasis). Using the established cut-off value for detecting SLN metastasis by OSNA in EC (250 copies/µL), the sensitivity of the OSNA assay was 92%, specificity was 82%, diagnostic accuracy was 83%, and the negative predictive value was 99%. Discordant results between both methods were recorded in 20 patients (13.6%). OSNA resulted in an upstaging in 12 patients (8.2%). OSNA could aid in the identification of patients requiring adjuvant treatment at the time of diagnosis.

Maximizing sentinel node detection in endometrial cancer with dual cervical and transcervical fundal indocyanine green injection: 5-year single-center prospective study.

OBJECTIVE: The aim of this study was to describe our latest results using dual cervical and fundal indocyanine green injection for detection of sentinel lymph node (SLN) in endometrial cancer. METHODS: A prospective observational study was conducted between 26 June 2014 and 31 December 2019 with 278 patients that underwent laparoscopic surgery for endometrial cancer at our institution. In all cases, we performed SLN biopsy with dual cervical and fundal indocyanine green injection. All SLNs were processed with an ultrastaging technique. A total of 128 patients also underwent total pelvic and paraaortic lymphadenectomy. RESULTS: The detection rates were as follows: 93.5 % (260/278) overall for SLNs; 90.7 % (252/278) overall for pelvic SLNs; 68.0 % (189/278) for bilateral SLNs; 66.9 % (186/278) for paraaortic SLNs, and 2.9 % (8/278) for isolated paraaortic SLNs. We found macroscopic lymph node metastasis in 26 patients (10.0 %) and microdisease in lymph nodes in another 48 patients, raising the overall rate of lymph node involvement to 16.2 %. There was one false negative (negative SLN biopsy but positive lymphadenectomy). Applying the SLN algorithm, the sensitivity of detection was 97.9 % (95 % CI 89.1-99.6), specificity 100 % (95 % CI 98.2-100), negative predictive value 99.5 % (95 % CI 97.4-99.9), and positive predictive value 100 % (95 % CI 92.4-100). CONCLUSIONS: Dual sentinel node injection is a feasible technique that achieves adequate detection rates. Additionally, this technique allows a high rate of aortic detection, identifying a non-negligible percentage of isolated aortic metastases. Aortic metastases in endometrial cancer are possible and we should not give up actively looking for them.

Impact of restaging lymphadenectomy after sentinel node biopsy on endometrial cancer.

INTRODUCTION: Approximately 10 % of patients with an intra-operative diagnosis of low-risk endometrial cancer (EC) will be upstaged after a definitive histological evaluation of hysterectomy and bilateral adnexectomy samples. This study aimed to explore the results associated with the performance of pelvic and para-aortic lymphadenectomy for restaging after upstaging/upgrading these patients, and to compare those who underwent sentinel lymph node biopsy (SNB) in the first procedure with those who did not. MATERIALS AND METHODS: This retrospective cohort study included 27 patients diagnosed with low-risk EC (based on the criteria of the European Society of Medical Oncology/European Society of Gynecological Oncology/European Society for Radiotherapy and Oncology), who underwent surgical laparoscopic restaging due to upstaging based on the final histological result at Hospital Universitario Donostia from April 2013 to September 2018. Surgical and oncological results were compared between patients who underwent hysterectomy and double adnexectomy without any additional procedures (SNB-; n = 17) and patients who also underwent pelvic&aortic sentinel node biopsysen (SNB+; n = 10). The main outcome evaluated in the study was intra-operative complications. Secondary outcomes were mean operative time, length of hospital stay, number of nodes obtained, progression-free survival (PFS) and overall survival (OS). RESULTS: The median duration of restaging surgery was 240 [interquartile range (IQR) 180-300) min in the SNB(-) group and 300 (IQR 247.5-330) min in the SNB(+) group; this difference was significant (one-sided Student's t-test, p = 0.0295). With regard to intra-operative complications, there were 17.65 % and 40 % in the SNB(-) and SNB(+) groups, respectively, all of which were vascular; this difference was not significant. There were no significant difference in the length of hospital stay, number of pelvic nodes obtained, PFS or OS between the groups. CONCLUSION: Women with EC who require lymph node restaging due to upstaging, and have previously undergone SNB, experience more surgical complications and a longer operative time. The authors advise against performing second restaging surgery in these patients.

Utility of Intraoperative Fluorescence Imaging in Gynecologic Surgery: Systematic Review and Consensus Statement.

BACKGROUND: This study aimed to review the current knowledge on the utility of intraoperative fluorescence imaging in gynecologic surgery and to give evidence-based recommendations to improve the quality of care for women who undergo gynecologic surgery. METHODS: A computer-based systematic review of the MEDLINE, CENTRAL, Pubmed, EMBASE, and SciSearch databases as well as institutional guidelines was performed. The time limit was set at 2000-2019. For the literature search, PRISMA guidelines were followed. A modified-Delphi method was performed in three rounds by a panel of experts to reach a consensus of conclusions and recommendations. RESULTS: Indocyanine green (ICG) is used primarily in gynecology for sentinel node-mapping. In endometrial and cervical cancer, ICG is a feasible, safe, time-efficient, and reliable method for lymphatic mapping, with better bilateral detection rates. Experience in vulvar cancer is more limited, with ICG used together with Tc-99 m as a dual tracer and alone in video endoscopic inguinal lymphadenectomy. In early ovarian cancer, results are still preliminary but promising. Indocyanine green fluorescence imaging also is used for ureteral assessment, allowing intraoperative ureteral visualization, to reduce the risk of ureteral injury during gynecologic surgery. CONCLUSIONS: For most gynecologic cancers, ICG fluorescence imaging is considered the tracer of choice for lymphatic mapping. The use of this new technology expands to a better ureteral assessment.

Machine Learning-Assisted Raman Spectroscopy for pH and Lactate Sensing in Body Fluids.

This study presents the combination of Raman spectroscopy with machine learning algorithms as a prospective diagnostic tool capable of detecting and monitoring relevant variations of pH and lactate as recognized biomarkers of several pathologies. The applicability of the method proposed here is tested both in vitro and ex vivo. In a first step, Raman spectra of aqueous solutions are evaluated for the identification of characteristic patterns resulting from changes in pH or in the concentration of lactate. The method is further validated with blood and plasma samples. Principal component analysis is used to highlight the relevant features that differentiate the Raman spectra regarding their pH and concentration of lactate. Partial least squares regression models are developed to capture and model the spectral variability of the Raman spectra. The performance of these predictive regression models is demonstrated by clinically accurate predictions of pH and lactate from unknown samples in the physiologically relevant range. These results prove the potential of our method to develop a noninvasive technology, based on Raman spectroscopy, for continuous monitoring of pH and lactate in vivo.

Accessory polar renal artery not pre-operatively visualized at extra-peritoneal para-aortic lymphadenectomy.

The objective of this video is to describe the technique of extra-peritoneal para-aortic laparoscopic lymphadenectomy and emphasize potential vascular risks that should be taken into account during the procedure.The procedure was performed at Donostia University Hospital, a tertiary referral and educational center in San Sebastián, Spain.A 58-year-old woman, body mass index 25.4 kg/m2, G2P2, with a diagnosis of intermediate-risk endometrial adenocarcinoma, International Federation of Gynecology and Obstetrics (FIGO) IBG2 based on pre-operative endometrial histology and pre-operative magnetic resonance imaging (MRI), but upstaged to high-risk endometrial adenocarcinoma on final report (IBG3). In our hospital, risk stratification is based on pelvic MRI (myometrial invasion, cervical invasion) and biopsy (histology and grade) to tailor surgery. Computed tomography (CT) scan pre-operatively is only performed for type 2 endometrial carcinoma and grade 3 histologies.The local institutional review board was consulted, which confirmed that the study was exempt from requiring approval.The patient underwent an extra-peritoneal para-aortic laparoscopic lymphadenectomy, trans-peritoneal bilateral pelvic lymphadenectomy, and a total hysterectomy and bilateral salpingo-oophorectomy.It is mandatory to check pre-operative imaging studies in order to identify vascular anomalies that are not uncommon and may increase the risk of vascular complications.1 Frequently these vascular anomalies, such as a retro-aortic left renal vein, or a double vena cava or left vena cava, may be a casual finding in the pre-operative study, and often such findings are not reported by the radiologist. It is vitally important that the surgeon checks for and identifies any such anomolies, as the risk of complications may be decreased if anomalies of this type are detected pre-operatively.In addition, in the case of existing polar renal arteries, these are frequently not identified in the pre-operative study,2 leading to a risk of injury and partial renal necrosis. There are several anatomical variations of the renal arteries, with an aortic lower polar artery found in 3% of cadavers and 1% of patients on CT, more frequently on the right side.3 Renovascular hypertension4 secondary to an injury of an accessory polar renal artery (APRA) has also been described.Although vascular anomalies, especially venous ones, are more frequently found at the infra-renal left level, in this video we show access to the right side of the dissection and the care that needs to be taken in order not to damage a vascular structure at this level. Special caution is required with the right side of the dissection so as not to injure any perforating veins, including Fellow's vein, when pushing all the nodes to the roof of the dissection.The dissection maneuvers are fine and blunt, establishing bridges of tissue to be sectioned, and thus identifying vascular structures, such as a right APRA that is to be identified and preserved.The surgeon must have a good knowledge of retro-peritoneal vascular anatomy, they should examine pre-operative imaging studies to check for vascular anomalies, and they need to possess an accurate surgical technique to avoid potential vascular injury during laparoscopic para-aortic lymphadenectomy.

Prevention of lymphorrhea in aortic lymphadenectomy.

The objective of this video 1 is to describe the technique to avoid postoperative lymphorrhea after a lumboaortic lymphadenectomy. All procedures were performed at Donostia University Hospital, a tertiary referral and educational center in San Sebastián, Spain. Lumboaortic extra-peritoneal lymphadenectomy was performed for several gynecological malignancies (endometrial and cervical cancer). During the procedure, afferent lymphatic capillaries were identified at the infra-renal aortic level and clipped to avoid retrograde lymphorrhea at this level. Numerous strategies have been described to reduce the likelihood of lymphorea and lymphocele formation.1 Harmonic scalpel and other sealing advanced devices are not useful to secure lymphatic leakage at this level, although some authors have published a clinical benefit in their use,2 while clips have been found useful to prevent leakage in other lymphatic locations.3 The use of harmonic scalpel, biological agents or surgical patch has been ineffective in our experience, but sealing clips and peritonization (marsupialization),4 once the procedure is concluded, could be an effective approach. Performing simple gestures during lumboaortic lymphadenectomy can help to reduce the appearance of posterior lymphorrhea.

Maximizing Sentinel Lymph Node Detection: Aortic Sentinel Lymph Node Detection in Endometrial Cancer.

STUDY OBJECTIVE: To determine the importance of a dual (cervical and fundal) indocyanine green (ICG) injection and thorough dissection for the detection of sentinel lymph nodes (SLNs). DESIGN: Description and step-by-step demonstration of the surgical procedure using video (Canadian Task Force classification III). SETTING: Hospital Universitario Donostia, San Sebastián, Spain. PATIENTS: A 60-year-old woman with a diagnosis of IAG1 endometrial adenocarcinoma (EC). INTERVENTIONS: The patient received a cervical and transcervical fundal ICG injection for para-aortic and pelvic SLN detection in the setting of a research protocol, followed by a total hysterectomy and bilateral salpingo-oophorectomy with a frozen section of the uterus as a standard approach [1]. Institutional Review Board approval was obtained for the research protocol of this study. MEASUREMENTS AND MAIN RESULTS: Dual ICG injection [2] adds the benefit of a cervical injection (that best evaluates the pelvic region [3]) to the fundal injection, with better spread to the lumboaortic pathway [4] so as not to lose the aortic drainage and aortic SLN, whose relevance is still discussed due to its low incidence of metastasis [5]. This search does not add to the associated morbidity but is associated with increased operative time. For pelvic SLN dissection, patience and good training are key; the surgeon must always be on the lookout for uncommon pathways if no SLN is detected in the classical areas. The final histological classification was upgraded to a grade IIIC2 (ie, micrometastasis in the aortic and pelvic-right pararectal space) EC, 3 cm G1 with no lymphovascular invasion. CONCLUSION: Dual ICG injection allows comprehensive mapping not only of pelvic SLNs, but also of para-aortic SLNs, in EC, maximizing the identification of all possible affected areas. Nonetheless, the relevance of its added benefit requires further evaluation.

Efficacy of a Fibrin Sealant (Tissucol Duo) for the Preventionof Lymphocele after Laparoscopic Pelvic Lymphadenectomy:A Randomized Controlled Trial.

STUDY OBJECTIVE: To assess the efficacy of Tissucol Duo (Baxter AG, Vienna, Austria) fibrin sealant in decreasing the incidence of lymphocele (LC) after pelvic laparoscopic lymph node dissection using harmonic shears. DESIGN: Randomized controlled trial (Canadian Task Force classification level I). SETTING: Tertiary referral and educational center. PATIENTS: Seventy-four patients randomized to the use of sealant per hemipelvis. INTERVENTION: Fibrin sealant. MEASUREMENTS AND MAIN RESULTS: After bilateral pelvic lymphadenectomy a fibrin sealant was used in 1 hemipelvis but not the other, applied in 41 patients (55.4%) to the left and 33 patients (44.6%) to the right hemipelvis. The primary outcome was the incidence of LC after surgery in symptomatic and asymptomatic patients. Imaging (ultrasound, computed tomography, and magnetic resonance) was performed to detect LC at 3, 6, and 12 months after surgery. Overall, 26 patients (35.1%) developed LC, and 4 were symptomatic (5.4%). Allowing patients to serve as their own treatment group and control, the hemipelvis treated with Tissucol Duo corresponding to the treatment group and that not treated to the control group, LCs were found in 17 (23%) and 14 (19%) cases, respectively, but the difference was not significant. The mean initial LC maximum diameter was 27.1 mm (standard deviaiotn, 35.2), and LCs tended to decrease in size during the first year to a mean of 8.7 mm. CONCLUSION: Application of Tissucol Duo fibrin sealant after laparoscopic pelvic lymphadenectomy using ultrasonic shears does not decrease the occurrence of symptomatic or asymptomatic LC.