Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer

Endometrial Cancer Clinical Trial

— SLN_EC  

Official title:

Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer: a Multicenter Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302714
• Other study ID #: INT 09/17
• Status: Completed
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: February 25, 2020

Study information

• Verified date: February 2020
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer: a multicenter prospective randomized study

Description:

Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: February 25, 2020
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Signed informed consent from the patient;

• Histological diagnosis of endometrial cancer (including type I and II EC);

• Early stage (FIGO stage < 4);

• Age older than 18 years.

Exclusion Criteria:

• Preoperative diagnosis of extra-uterine disease;

• Preoperative suspicious of gross positive nodes;

• Execution of neoadjuvant chemotherapy;

• Contraindication to upfront general anesthesia and or mini-invasive surgery;

• Systemic infections ongoing;

• Pregnancy ongoing.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Procedure:
• Hysteroscopic injection
Hysteroscopic injection
• Cervical injection
Cervical injection

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale Tumori	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

References & Publications (11)

Cormier B, Rozenholc AT, Gotlieb W, Plante M, Giede C; Communities of Practice (CoP) Group of Society of Gynecologic Oncology of Canada (GOC). Sentinel lymph node procedure in endometrial cancer: A systematic review and proposal for standardization of future research. Gynecol Oncol. 2015 Aug;138(2):478-85. doi: 10.1016/j.ygyno.2015.05.039. Epub 2015 Jun 3. Review. — View Citation

Ditto A, Martinelli F, Bogani G, Papadia A, Lorusso D, Raspagliesi F. Sentinel node mapping using hysteroscopic injection of indocyanine green and laparoscopic near-infrared fluorescence imaging in endometrial cancer staging. J Minim Invasive Gynecol. 2015 Jan;22(1):132-3. doi: 10.1016/j.jmig.2014.08.009. Epub 2014 Aug 15. — View Citation

Gargiulo T, Giusti M, Bottero A, Leo L, Brokaj L, Armellino F, Palladin L. Sentinel Lymph Node (SLN) laparoscopic assessment early stage in endometrial cancer. Minerva Ginecol. 2003 Jun;55(3):259-62. — View Citation

Maccauro M, Lucignani G, Aliberti G, Villano C, Castellani MR, Solima E, Bombardieri E. Sentinel lymph node detection following the hysteroscopic peritumoural injection of 99mTc-labelled albumin nanocolloid in endometrial cancer. Eur J Nucl Med Mol Imaging. 2005 May;32(5):569-74. Epub 2004 Dec 30. — View Citation

Martinelli F, Ditto A, Bogani G, Signorelli M, Chiappa V, Lorusso D, Haeusler E, Raspagliesi F. Laparoscopic Sentinel Node Mapping in Endometrial Cancer After Hysteroscopic Injection of Indocyanine Green. J Minim Invasive Gynecol. 2017 Jan 1;24(1):89-93. doi: 10.1016/j.jmig.2016.09.020. Epub 2016 Oct 8. — View Citation

Niikura H, Okamura C, Utsunomiya H, Yoshinaga K, Akahira J, Ito K, Yaegashi N. Sentinel lymph node detection in patients with endometrial cancer. Gynecol Oncol. 2004 Feb;92(2):669-74. — View Citation

Pelosi E, Arena V, Baudino B, Bellò M, Gargiulo T, Giusti M, Bottero A, Leo L, Armellino F, Palladin D, Bisi G. Preliminary study of sentinel node identification with 99mTc colloid and blue dye in patients with endometrial cancer. Tumori. 2002 May-Jun;88(3):S9-10. — View Citation

Pelosi E, Arena V, Baudino B, Bellò M, Giusti M, Gargiulo T, Palladin D, Bisi G. Pre-operative lymphatic mapping and intra-operative sentinel lymph node detection in early stage endometrial cancer. Nucl Med Commun. 2003 Sep;24(9):971-5. — View Citation

Perrone AM, Casadio P, Formelli G, Levorato M, Ghi T, Costa S, Meriggiola MC, Pelusi G. Cervical and hysteroscopic injection for identification of sentinel lymph node in endometrial cancer. Gynecol Oncol. 2008 Oct;111(1):62-7. doi: 10.1016/j.ygyno.2008.05.032. Epub 2008 Jul 14. — View Citation

Raspagliesi F, Ditto A, Kusamura S, Fontanelli R, Vecchione F, Maccauro M, Solima E. Hysteroscopic injection of tracers in sentinel node detection of endometrial cancer: a feasibility study. Am J Obstet Gynecol. 2004 Aug;191(2):435-9. — View Citation

Solima E, Martinelli F, Ditto A, Maccauro M, Carcangiu M, Mariani L, Kusamura S, Fontanelli R, Grijuela B, Raspagliesi F. Diagnostic accuracy of sentinel node in endometrial cancer by using hysteroscopic injection of radiolabeled tracer. Gynecol Oncol. 2012 Sep;126(3):419-23. doi: 10.1016/j.ygyno.2012.05.025. Epub 2012 May 30. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate	assessment of Detection rate in the para-aortic area	30 month
Secondary	Detection rate	Detection rate in the pelvic area	30 month
Secondary	Operative time	Operative time to detect and remove sentinel node	30 month
Secondary	Intraoperative complications	Intraoperative complications during the sentinel lymph node dissection	30 month
Secondary	Postoperative complications	Postoperative complications graded per the Clavien-Dindo Classification system	30 month