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

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Hysteroscopic injection
Cervical injection
Sponsored by
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring Cervical injection, Hysteroscopic injection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Fondazione IRCCS Istituto Nazionale Tumori

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

cervical injection

hysteroscopic injection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Detection rate
assessment of Detection rate in the para-aortic area

Secondary Outcome Measures

Detection rate
Detection rate in the pelvic area
Operative time
Operative time to detect and remove sentinel node
Intraoperative complications
Intraoperative complications during the sentinel lymph node dissection
Postoperative complications
Postoperative complications graded per the Clavien-Dindo Classification system

Full Information

First Posted
February 26, 2020
Last Updated
March 10, 2020
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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1. Study Identification

Unique Protocol Identification Number
NCT04302714
Brief Title
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer
Acronym
SLN_EC
Official Title
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer: a Multicenter Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
March 28, 2019 (Actual)
Study Completion Date
February 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
Cervical injection, Hysteroscopic injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cervical injection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
hysteroscopic injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hysteroscopic injection
Intervention Description
Hysteroscopic injection
Intervention Type
Procedure
Intervention Name(s)
Cervical injection
Intervention Description
Cervical injection
Primary Outcome Measure Information:
Title
Detection rate
Description
assessment of Detection rate in the para-aortic area
Time Frame
30 month
Secondary Outcome Measure Information:
Title
Detection rate
Description
Detection rate in the pelvic area
Time Frame
30 month
Title
Operative time
Description
Operative time to detect and remove sentinel node
Time Frame
30 month
Title
Intraoperative complications
Description
Intraoperative complications during the sentinel lymph node dissection
Time Frame
30 month
Title
Postoperative complications
Description
Postoperative complications graded per the Clavien-Dindo Classification system
Time Frame
30 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonino Ditto, MD
Organizational Affiliation
Fonsazione IRCCS Istituto Nazionale Tumori Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Istituto Nazionale Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
27725278
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.
Results Reference
background
PubMed Identifier
15625604
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. doi: 10.1007/s00259-004-1709-4. Epub 2004 Dec 30.
Results Reference
background
PubMed Identifier
15343218
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. doi: 10.1016/j.ajog.2004.03.008.
Results Reference
background
PubMed Identifier
14766264
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. doi: 10.1016/j.ygyno.2003.10.039.
Results Reference
background
PubMed Identifier
14581872
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.
Results Reference
background
PubMed Identifier
12960596
Citation
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.
Results Reference
background
PubMed Identifier
12365393
Citation
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.
Results Reference
background
PubMed Identifier
25135786
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.
Results Reference
background
PubMed Identifier
22659192
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.
Results Reference
background
PubMed Identifier
18625518
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.
Results Reference
background
PubMed Identifier
26047592
Citation
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.
Results Reference
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Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer

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