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

NCT04302714 | Completed

• 1 other identifier: INT 09/17
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometrial Cancer

Keywords

Cervical injection; Hysteroscopic injection

Outcome Measures

Primary Outcomes (1)

• Detection rate

  assessment of Detection rate in the para-aortic area

  30 month

Secondary Outcomes (4)

• Detection rate

  30 month

• Operative time

  30 month

• Intraoperative complications

  30 month

• Postoperative complications

  30 month

Study Arms (2)

cervical injection

ACTIVE COMPARATOR

Fluorescent SLN Imaging With Indocyanine Green (ICG), using near-infrared fluorescence imaging, will be used as a dye for SLN mapping. Injections will be performed intraoperative. Concentration of ICG used is 1.25mg/mL, the 25mg dry powder bottle is mixed with 20 mL of sterile water in the operating room, and 4 mL is injected directly into the cervix. This solution was injected intracervically at 3 and 9 o'clock positions, both submucosally and deep into the cervical stroma. A spinal needle 18-gauce is used to inject the ICG. The 4 mL can be divided into 4 separate injections (1 mL each). The ICG should be injected slowly, at a rate of 5 to 10 seconds per quadrant.

Procedure: Cervical injection

hysteroscopic injection

EXPERIMENTAL

hysteroscopy is performed using an operative hysteroscope. Uterine distension is obtained by means of saline solution. Usually, the fluid bag is placed 50 cm above the patient's plane so that the intracavitary pressure does not exceed 40 mm Hg. After visualization of uterine cavity a 22-gauce, 40-mm needle was introduced into the operative port and IGC is injected peritumorally. Concentration of ICG used is 1.25mg/mL, the 25mg dry powder bottle is mixed with 20 mL of sterile water in the operating room. The injection is performed subendometrially around the lesion, or, if the uterine cavity was totally involved by disease, at 3, 6, 9, and 12 o'clock . The depth of needle placement is modulated by visualizing endometrial elevation during injection.

Procedure: Hysteroscopic injection

Interventions

Hysteroscopic injection PROCEDURE

Hysteroscopic injection

hysteroscopic injection

Cervical injection PROCEDURE

Cervical injection

cervical injection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

Location

Related Publications (11)

• 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.

  PMID: 27725278 BACKGROUND

• 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. doi: 10.1007/s00259-004-1709-4. Epub 2004 Dec 30.

  PMID: 15625604 BACKGROUND

• 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. doi: 10.1016/j.ajog.2004.03.008.

  PMID: 15343218 BACKGROUND

• 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. doi: 10.1016/j.ygyno.2003.10.039.

  PMID: 14766264 BACKGROUND

• 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.

  PMID: 14581872 BACKGROUND

• Pelosi E, Arena V, Baudino B, Bello 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. doi: 10.1097/00006231-200309000-00005.

  PMID: 12960596 BACKGROUND

• Pelosi E, Arena V, Baudino B, Bello 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. doi: 10.1177/030089160208800322.

  PMID: 12365393 BACKGROUND

• 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.

  PMID: 25135786 BACKGROUND

• 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.

  PMID: 22659192 BACKGROUND

• 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.

  PMID: 18625518 BACKGROUND

• 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.

  PMID: 26047592 BACKGROUND

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

• Antonino Ditto, MD

  Fonsazione IRCCS Istituto Nazionale Tumori Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 10, 2020
• Study Start: March 20, 2017
• Primary Completion: March 28, 2019
• Study Completion: February 25, 2020
• Last Updated: March 12, 2020

Record last verified: 2020-02

Locations

IT (1)