Use of an Intrauterine Manipulator and Its Correlation with Positive Peritoneal Cytology in Early Stage Endometrial Cancers

NCT04570553 | Recruiting

• 1 other identifier: 1627644
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to answer whether use of a Vcare® intrauterine manipulator leads to an increased incidence of positive peritoneal cytology in patients undergoing surgical management of early stage (FIGO stage I/II) endometrial cancer.

Conditions

Endometrial Cancer

Keywords

endometrial cancer; peritoneal cytology

Outcome Measures

Primary Outcomes (1)

• Conversion of positive peritoneal cytology

  Intraoperative conversion rate from negative to positive peritoneal cytology will be assessed in each arm

  2 years

Secondary Outcomes (1)

• Recurrence rate

  2 years

Study Arms (2)

V-care uterine manipulator

EXPERIMENTAL

Patients in the V-care uterine manipulator arm will undergo standard staging surgery utilizing a V-care uterine manipulator in the standard fashion

Procedure: surgical staging

Sponge stick

ACTIVE COMPARATOR

Patients in the sponge stick arm will undergo standard staging surgery utilizing a non-invasive sponge stick for cervical delineation.

Procedure: surgical staging

Interventions

surgical staging PROCEDURE

Patients will undergo standard surgical staging for endometrial cancer utilizing either a V-care uterine manipulator or sponge stick

Sponge stick; V-care uterine manipulator

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female subjects age 18 and older
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects age 18 or older able to give informed consent
• Biopsy diagnosed endometrial cancer (including endometrioid, serous, mucinous and clear cell histologies)
• Planned standard of care surgical management of early stage endometrial cancer
• No clinical evidence of disseminated intraperitoneal disease

You may not qualify if:

• Final pathology does not reflect diagnosis of endometrial cancer (including endometrioid, serous, mucinous, and clear cell histology)
• Evidence of disseminated intraperitoneal disease
• Subject is not a surgical candidate
• Subject elects for fertility sparing or non-operative management
• Subject is unable to provide informed consent

Sponsors & Collaborators

• WellSpan Health: lead

Study Sites (1)

Wellspan Health

York, Pennsylvania, 17403, United States

RECRUITING

Related Publications (22)

• World Cancer Research Fund/American Institute for Cancer Research. Diet, Nutrition, Physical Activity and Cancer: a Global Perspective. Continuous Update Project Expert Report 2018. Available at dietandcancerreport.org.

  BACKGROUND

• Campos SM, Lee LJ, Del Carmen, MG, McMeekin DS. Corpus: Epithelial Tumors. In DS Chi, A Berchuk, DS Dizon, and CM Yashar (Eds.), Principles and Practice of Gynecologic Oncology. (pp 511) Philadelphia, PA: Wolters Kluwer.

  BACKGROUND

• Fung-Kee-Fung M, Dodge J, Elit L, Lukka H, Chambers A, Oliver T; Cancer Care Ontario Program in Evidence-based Care Gynecology Cancer Disease Site Group. Follow-up after primary therapy for endometrial cancer: a systematic review. Gynecol Oncol. 2006 Jun;101(3):520-9. doi: 10.1016/j.ygyno.2006.02.011. Epub 2006 Mar 23.

  PMID: 16556457 BACKGROUND

• 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.

  PMID: 3652025 BACKGROUND

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  PMID: 10791524 BACKGROUND

• Creasman WT, Rutledge F. The prognostic value of peritoneal cytology in gynecologic malignant disease. Am J Obstet Gynecol. 1971 Jul 15;110(6):773-81. doi: 10.1016/0002-9378(71)90571-0. No abstract available.

  PMID: 5561996 BACKGROUND

• Kasamatsu T, Onda T, Katsumata N, Sawada M, Yamada T, Tsunematsu R, Ohmi K, Sasajima Y, Matsuno Y. Prognostic significance of positive peritoneal cytology in endometrial carcinoma confined to the uterus. Br J Cancer. 2003 Jan 27;88(2):245-50. doi: 10.1038/sj.bjc.6600698.

  PMID: 12610496 BACKGROUND

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  PMID: 15578078 BACKGROUND

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  PMID: 2748053 BACKGROUND

• Scott SA, van der Zanden C, Cai E, McGahan CE, Kwon JS. Prognostic significance of peritoneal cytology in low-intermediate risk endometrial cancer. Gynecol Oncol. 2017 May;145(2):262-268. doi: 10.1016/j.ygyno.2017.03.011. Epub 2017 Mar 28.

  PMID: 28359690 BACKGROUND

• Lee B, Suh DH, Kim K, No JH, Kim YB. Influence of positive peritoneal cytology on prognostic factors and survival in early-stage endometrial cancer: a systematic review and meta-analysis. Jpn J Clin Oncol. 2016 Aug;46(8):711-7. doi: 10.1093/jjco/hyw063. Epub 2016 May 20.

  PMID: 27207885 BACKGROUND

• Garg G, Gao F, Wright JD, Hagemann AR, Mutch DG, Powell MA. Positive peritoneal cytology is an independent risk-factor in early stage endometrial cancer. Gynecol Oncol. 2013 Jan;128(1):77-82. doi: 10.1016/j.ygyno.2012.09.026. Epub 2012 Sep 29.

  PMID: 23032094 BACKGROUND

• Seagle BL, Alexander AL, Lantsman T, Shahabi S. Prognosis and treatment of positive peritoneal cytology in early endometrial cancer: matched cohort analyses from the National Cancer Database. Am J Obstet Gynecol. 2018 Mar;218(3):329.e1-329.e15. doi: 10.1016/j.ajog.2017.11.601. Epub 2017 Dec 6.

  PMID: 29223598 BACKGROUND

• Ramirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, Buda A, Yan X, Shuzhong Y, Chetty N, Isla D, Tamura M, Zhu T, Robledo KP, Gebski V, Asher R, Behan V, Nicklin JL, Coleman RL, Obermair A. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31.

  PMID: 30380365 BACKGROUND

• Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009 Nov 10;27(32):5331-6. doi: 10.1200/JCO.2009.22.3248. Epub 2009 Oct 5.

  PMID: 19805679 BACKGROUND

• Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Barakat R, Pearl ML, Sharma SK. Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group LAP2 Study. J Clin Oncol. 2012 Mar 1;30(7):695-700. doi: 10.1200/JCO.2011.38.8645. Epub 2012 Jan 30.

  PMID: 22291074 BACKGROUND

• Logani S, Herdman AV, Little JV, Moller KA. Vascular "pseudo invasion" in laparoscopic hysterectomy specimens: a diagnostic pitfall. Am J Surg Pathol. 2008 Apr;32(4):560-5. doi: 10.1097/PAS.0b013e31816098f0.

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  PMID: 24582867 BACKGROUND

• Sonoda Y, Zerbe M, Smith A, Lin O, Barakat RR, Hoskins WJ. High incidence of positive peritoneal cytology in low-risk endometrial cancer treated by laparoscopically assisted vaginal hysterectomy. Gynecol Oncol. 2001 Mar;80(3):378-82. doi: 10.1006/gyno.2000.6079.

  PMID: 11263935 BACKGROUND

• Lim S, Kim HS, Lee KB, Yoo CW, Park SY, Seo SS. Does the use of a uterine manipulator with an intrauterine balloon in total laparoscopic hysterectomy facilitate tumor cell spillage into the peritoneal cavity in patients with endometrial cancer? Int J Gynecol Cancer. 2008 Sep-Oct;18(5):1145-9. doi: 10.1111/j.1525-1438.2007.01165.x. Epub 2008 Jan 22.

  PMID: 18217979 BACKGROUND

• Eltabbakh GH, Mount SL. Laparoscopic surgery does not increase the positive peritoneal cytology among women with endometrial carcinoma. Gynecol Oncol. 2006 Feb;100(2):361-4. doi: 10.1016/j.ygyno.2005.08.040. Epub 2005 Sep 26.

  PMID: 16185754 BACKGROUND

• Lee M, Kim YT, Kim SW, Kim S, Kim JH, Nam EJ. Effects of uterine manipulation on surgical outcomes in laparoscopic management of endometrial cancer: a prospective randomized clinical trial. Int J Gynecol Cancer. 2013 Feb;23(2):372-9. doi: 10.1097/IGC.0b013e3182788485.

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MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Eav Lim, DO

  WellSpan Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Graham Brown, DO

CONTACT

717-851-6120; gbrown5@wellspan.org

Eav Lim, DO

CONTACT

717-851-6120; elim@wellspan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Site Director, Gynecology Oncology

Model Details: Subjects are randomized to one of two groups in parallel: V-care uterine manipulator group or sponge stick group

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: September 30, 2020
• Study Start: October 15, 2020
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 28, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)