Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
635 participants
INTERVENTIONAL
2018-12-15
2020-06-30
Brief Summary
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Detailed Description
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The program change process is as follows:
* Identify the problems and understand the necessary to change the plan;
* Convene the main members of the research team and the project leader to discuss and propose solutions;
* Revise the plan and update the version number, fill out the "Program Description";
* The revised plan and the "Revision of the Plan" need to be signed by the person in charge of the project. If necessary, they must be submitted to the ethics committee for approval or filing; if approved, the revised plan can be implemented.
B. In order to ensure that the research personnel have sufficient qualifications to undertake specific research work, the research personnel should at least complete the following training before the project starts:
* Research object protection and ethical requirements;
* Study protocols and related standard operating procedures (tracer injection methods, use of near-infrared fluorescent vascular imagers, and pathology);
* Case Report Form and gauge filling instructions (form entry criteria, surgical record methods, etc.);
* Clinical research project implementation considerations (such as research object screening, enrollment, data collection process); Project-related training should be carried out throughout the research process. The project leader and project coordinator can increase the training content according to the situation, such as training on weak links in the test, training on updating programs and various causes.
Data Management A. Case report form design The researcher is responsible for drafting the research case report form. B. Data Entry and Data Verification According to the final version of CRF, the project database is built using software. The data entry and verification is carried out by a dedicated person.
Statistical Analysis A. Statistical Analysis Plan and Statistical Software After the trial protocol is determined, the statistical professors and the main investigators are responsible for developing a statistical analysis plan. The statistical analysis software uses SAS® 9.2 software (software installation point authorization number: 11202165).
B. Calculation and reasoning of sample size The sample size is calculated using PASS11 software; the sample size is estimated based on the negative prediction value of the previous study, and the negative prediction value of SLNs is expected to be 95%; the allowable error is 2% (the range of the confidence interval is 93% to 97%). When the significant level is 0.05, 508 cases are needed to be studied. Considering the detection rate of 80% of SLNs, a total of 635 cases are expected to be studied.
C. Statistical Analysis Methods General principle Using a two-sided test, a P value of less than 0.05 would be considered statistically significant.
The quantitative indicators will calculate the mean, standard deviation, median, minimum, maximum, lower quartile (Q1), upper quartile (Q3), and the classification indicators will describe the number of cases and percentages.
Comparison of clinicopathological features (age, body mass index, pathological type, tumor stage, grading, maximum tumor diameter, invasive myometrial depth, lymphatic vascular infiltration, and tracer method) for SLNs and undetected SLNs will be based on the type of indicator. For the comparison of quantitative data between groups, the t-test or Wilcoxon rank sum test will be used according to the data distribution. For the comparison of categorical data between groups, the data will be analyzed by chi-square test or exact probability method (if the chi-square test is not applicable). And the grade data was analyzed by Wilcoxon rank sum test or CMH test.
Clinical diagnostic index calculation According to the true positive (TP), false negative (FN), true negative (TN), and false positive (FP), the results of SLNs pathological examination and all lymph node pathological examination results will be compared. The comparison results will be plotted as a four-grid table to calculate sensitivity, false negative rate, and negative predictive value, respectively.
Chi-square test or exact probability method (if the chi-square test is not applicable) will be used to compare the clinical diagnosis value of SLNs biopsy of endometrial cancer patients with injection of carbon nanoparticles (CNP) or combined injection of CNP and indocyanine green(ICG).
Chi-square test or exact probability method (if the chi-square test is not applicable) will be used to analyze the clinic-pathological factors affecting the detection rate of SLNs.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
1. Recruiting endometrial cancer patients undergoing hysterectomy with or without bilateral adnexectomy, pelvic and para-aortic lymph node resection from July 2018 to June 2020.
2. Selecting the Standard-compliant patients according to the inclusion and exclusion criteria and letting them sign an informed consent form.
3. Numbering the above patients and collecting their clinical data.
4. Injecting carbon nanoparticles (CNP)\[Not Equipped with near-infrared fluorescent vascular imager\] or CNP combining Indocyanine Green(ICG)\[Equipped with near-infrared fluorescent vascular imager\].
5. Identifying and removing sentinel lymph nodes.
6. Completing the hysterectomy with or without bilateral adnexectomy, pelvic and para-aortic lymph node resection
7. Staining all nodes using hematoxylin-eosin staining.
8. Calculating the sensitivity, negative predictive value, etc.
DIAGNOSTIC
NONE
Study Groups
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Undergoing sentinel lymph node biopsy
Sentinel Lymph Node Biopsy
1. Injecting carbon nanoparticles (CNP)\[Not Equipped with near-infrared fluorescent vascular imager\] or CNP combining Indocyanine Green(ICG)\[Equipped with near-infrared fluorescent vascular imager\].
2. Identifying and removing sentinel lymph nodes.
3. Staining all nodes using hematoxylin-eosin staining.
Interventions
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Sentinel Lymph Node Biopsy
1. Injecting carbon nanoparticles (CNP)\[Not Equipped with near-infrared fluorescent vascular imager\] or CNP combining Indocyanine Green(ICG)\[Equipped with near-infrared fluorescent vascular imager\].
2. Identifying and removing sentinel lymph nodes.
3. Staining all nodes using hematoxylin-eosin staining.
Eligibility Criteria
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Inclusion Criteria
* Decide to receive hysterectomy with or without bilateral adnexectomy, pelvic and para-aortic lymph node resection
* Agree to conduct the study and sign an informed consent form
Exclusion Criteria
* Other history of pelvic or abdominal malignant tumors in the past 5 years
* Intolerable for surgery due to severe comorbidities
* During a period of pregnancy
* Allergic to the tracer
* Diagnosis of uncontrolled epilepsy, central nervous system disease or mental disorder, with the judgment from the investigator that the above diseases would affect clinical research compliance.
18 Years
80 Years
FEMALE
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Peking University International Hospital
OTHER
Shanghai First Maternity and Infant Hospital
OTHER
Obstetrics & Gynecology Hospital of Fudan University
OTHER
Sun Yat-sen University
OTHER
Tianjin Central Hospital of Gynecology Obstetrics
OTHER
Cancer Hospital of Guangxi Medical University
OTHER
First People's Hospital of Foshan
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Second Affiliated Hospital of Zhengzhou University
OTHER
Beijing Blue Sky Shared Health Management Co., Ltd.
UNKNOWN
Chongqing Lummy Pharmaceutical Co.,Ltd.
UNKNOWN
Peking University People's Hospital
OTHER
Responsible Party
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Locations
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Peking University People's Hosoital
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Jianliu Wang, Professor
Role: primary
References
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Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
Creasman WT, Morrow CP, Bundy BN, Homesley HD, Graham JE, Heller PB. Surgical pathologic spread patterns of endometrial cancer. A Gynecologic Oncology Group Study. Cancer. 1987 Oct 15;60(8 Suppl):2035-41. doi: 10.1002/1097-0142(19901015)60:8+3.0.co;2-8.
May K, Bryant A, Dickinson HO, Kehoe S, Morrison J. Lymphadenectomy for the management of endometrial cancer. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007585. doi: 10.1002/14651858.CD007585.pub2.
Benedetti Panici P, Basile S, Maneschi F, Alberto Lissoni A, Signorelli M, Scambia G, Angioli R, Tateo S, Mangili G, Katsaros D, Garozzo G, Campagnutta E, Donadello N, Greggi S, Melpignano M, Raspagliesi F, Ragni N, Cormio G, Grassi R, Franchi M, Giannarelli D, Fossati R, Torri V, Amoroso M, Croce C, Mangioni C. Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial. J Natl Cancer Inst. 2008 Dec 3;100(23):1707-16. doi: 10.1093/jnci/djn397. Epub 2008 Nov 25.
ASTEC study group; Kitchener H, Swart AM, Qian Q, Amos C, Parmar MK. Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study. Lancet. 2009 Jan 10;373(9658):125-36. doi: 10.1016/S0140-6736(08)61766-3. Epub 2008 Dec 16.
Todo Y, Kato H, Kaneuchi M, Watari H, Takeda M, Sakuragi N. Survival effect of para-aortic lymphadenectomy in endometrial cancer (SEPAL study): a retrospective cohort analysis. Lancet. 2010 Apr 3;375(9721):1165-72. doi: 10.1016/S0140-6736(09)62002-X. Epub 2010 Feb 24.
NCCN Guidelines Version 1. 2018. Uterine Neoplasms [EB/OL]. [2018-02-10]. http://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf.
Lu Y, Wei JY, Yao DS, Pan ZM, Yao Y. Application of carbon nanoparticles in laparoscopic sentinel lymph node detection in patients with early-stage cervical cancer. PLoS One. 2017 Sep 5;12(9):e0183834. doi: 10.1371/journal.pone.0183834. eCollection 2017.
Holloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28.
Liang SC, Wang ZQ, Wang JL. [Clinical analysis of 76 cases of sentinel lymph node detection in cervical cancer and endometrial cancer]. Zhonghua Fu Chan Ke Za Zhi. 2017 Sep 25;52(9):605-611. doi: 10.3760/cma.j.issn.0529-567X.2017.09.006. Chinese.
Other Identifiers
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2018PHD002-01
Identifier Type: -
Identifier Source: org_study_id