Sentinel Lymph Node in Early Ovarian Cancer

NCT03452982CompletedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Instituto de Investigacion Sanitaria La Fe

Enrollment

20

Start Date

2018-03-23

Completion Date

2019-08-21

Study Type

INTERVENTIONAL

Official Title

Sentinel Lymph Node in Early Ovarian Cancer

Interventions

sentinel node technique

Conditions

Ovarian Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Informed consent signed previously to performing any procedure related to the clinical trial.
* Patients who are women 18 years of age or older at the moment of the randomization.
* Patients with anatomopathological diagnosis of malignant ovarian tumor in a deferred study proposals for staging surgery or patients with suspicious tumor of malignancy who are going to be subjected to exploratory lapaotomy or laparoscopy and operative biopsy, and in the case this is positive, surgery of staging will be performed .

Exclusion Criteria:

* Informed consent not obtained or withdraw.
* Benign result in extemporaneous study
* Previous history of vascular surgery in the aorta, cava or pelvic vessels
* Previous pelvic or para-aortic lymphadenectomy
* Previous lymphoma
* Previous abdomino-pelvic tumor
* Previous allergic reaction to indocyanine green
* Pregnancy / lactation
* Severe adherent syndrome

Outcome Measures

Primary Outcomes

Feasibility of performing the sentinel node technique (Detection rate)

The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with previous ovarian surgery injecting the tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.

Time frame: Intraoperative (day 0)

Secondary Outcomes

Rate of realization of the technique

Time frame: Intraoperative (day 0)

Rate of realization of the technique

Time frame: After anatomopathological study (day 30)

Anatomical location of the sentinel node(s)

Assessed by radiation (99Tc-nanocoloides) and staining with indocyanine green

Time frame: Intraoperative (day 0)

Anatomical location of the sentinel node(s)

Assessed by the pathologist

Time frame: After anatomopathological study (day 30)

Number of detected sentinel nodes

Time frame: Intraoperative (day 1)

Number of detected sentinel nodes

Time frame: After anatomopathological study (day 30)

Characterization of the sample by collecting baseline characteristics

Age (years)

Time frame: Screening (day 0)

Characterization of the sample by collecting baseline characteristics

Weight (kilograms)

Time frame: Screening (day 0)

Characterization of the sample by collecting baseline characteristics

Height (centimeters)

Time frame: Screening (day 0)

Characterization of the sample by collecting baseline characteristics

BMI (kg/m\^2)

Time frame: Screening (day 0)

Characterization of the sample by collecting baseline characteristics

Previous gynecological surgery and previous pathological anatomy

Time frame: Screening (day 0)

Characterization of the sample by collecting tumor markers

Ca 125 and Ca 19.9.

Time frame: Day 0

Characterization of the sample by collecting intraoperative findings

Ascites (milliliters)

Time frame: Day 0

Characterization of the sample by collecting intraoperative findings

Tumor size (centimeters) of: right ovary, left ovary, right tube, left tube, uterus, pelvic nodes, para-aortic nodes, and tumor in upper hemiabdomen.

Time frame: Day 0

Characterization of the sample by collecting surgical procedures

Hysterectomy, adnexectomy, appendectomy, peritonectomy / peritoneal biopsy, omentectomy, lymphadenectomy and blood transfusion (Realized or Unrealized)

Time frame: Day 0

Characterization of the sample by collecting surgical procedures

Intraoperative complications

Time frame: Day 0

Characterization of the sample by collecting surgical procedures

Result of intraoperative biopsy (unrealized, malignant, benign)

Time frame: Day 0

Characterization of the sample by collecting surgical procedures

Estimated blood loss (milliliters)

Time frame: Day 0

Characterization of the sample by collecting surgical procedures

Surgical time (minutes)

Time frame: Day 0

Locations

Hospital Universitario y Politécnico La Fe, Valencia, Spain

Linked Papers

2021-03-10

Ultrastaging protocol in sentinel lymph node for apparent early stage ovarian cancer

The objective of the present study is to determine the role of sentinel lymph node (SLN) ultrastaging in apparent early-stage ovarian cancer. We previously demonstrated the feasibility of SLN in early-stage ovarian cancer in a pilot study and in a clinical trial (NCT03452982). The SLN of the 30 patients involved in both were processed following an ultrastaging protocol. The cost of ultrastaging processing was also reported. A SLN was detected in up to 91.3% and 90% in the pelvic and para-aortic region, respectively. In all cases, a SLN was detected at least in one field, pelvic or para-aortic. The mean time from injection to SLN resection was 53.3 ± 20.3 min. Two of 30 (6.6%) patients had a contralateral SLN in the para-aortic field, but no patients had contralateral SLN within the pelvic field after injection. The mean number of harvested SLN was 2.1 ± 1.4 (range: 0-5) and 2.7 ± 1.5 (range: 0-7) in the pelvic and para-aortic region, respectively. Two patients were upgraded to stage IIIA1 because of lymph node metastasis. In the first case, based on single sections and haematoxylin and eosin (H&E) examination, a pelvic SLN micrometastasis (1 mm) was found on the first H&E section. By using the ultrastaging protocol, the size of the metastasis was increased to 2.1 mm (macrometastasis). In the same patient, the ultrastaging study of the inframesenteric para-cava SLNs found isolated tumour cells in the subcapsular and interfollicular lymph nodes sinus in one of the two SLN harvested (in one of the sections at the fourth and fifth ultrastage levels). The other upstaged case was a para-aortic macrometastasis in a patient in whom the SLN was not identified in the para-aortic field because of the absence of migration from the infundibulo-pelvic stump injection. The cost of ultrastaging in each patient depended on the total number of SLN retrieved, averaging 96.8 € (range: 0-230.5) and 124.5 € (range: 0-322.7€) for pelvic and para-aortic SLN, respectively. A uniform protocol for ultrastaging is essential for lower-volume metastasis detection and to provide reproducible information between upcoming studies, as evidence about SLN in ovarian cancer is growing.

2019-10-16

Sentinel Lymph Node Technique in Apparent Early Ovarian Cancer: Laparoscopic Technique

To demonstrate the feasibility of laparoscopic sentinel lymph node technique in presumed early-stage ovarian cancer. Video illustrating the laparoscopic performance of the sentinel lymph node technique in ovarian cancer. The Oncologic Gynecology Department at the University Hospital La Fe. Candidates for the technique presented an apparent early stage ovarian cancer. The technique was performed in the context of a clinical trial called SENTOV (NCT03452982). To date, lymphadenectomy is recommended after the diagnosis of apparent early-stage ovarian cancer as part of the surgical staging. Minimally invasive surgery can be considered for the purpose of restaging [1]. Up to 14% of the patients are upstaged because of positive lymph nodes after pelvic and para-aortic lymphadenectomy [2]. Regarding low-grade tumors, a lower rate of lymph node involvement has been reported [3]. Sentinel lymph node technique has been reported to be feasible in a recent pilot study [4]. Two clinical trials (Sentinel Lymph Node in Early Ovarian Cancer and Sentine Lymph Node in Early Ovarian Cancer) are currently ongoing to clarify the use of sentinel lymph node technique in early ovarian cancer. The injection points were at the infundibulopelvic and ovarian ligament stumps. Two hundred microliters of saline solution containing 37 MBq of technetium-99m nanocolloid followed by 0.5 mL of indocyanine green (ICG) was injected subperitoneally. We used a 27 G needle at each injection point. Immediately after injection and also at 15 and 30 minutes after injection, the operative field was checked guided by the acoustic signal of the gamma probe and the near-infrared camera. We performed a minimum dissection looking for the sentinel lymph node or nodes in the pelvic and para-aortic region. Any lymph node with a remarkable radioactivity count as high as 10 times the background and/or dyed with ICG was considered a sentinel lymph node and was harvested separately. A systematic surgical staging was performed after the sentinel lymph node procedure was completed. Because of its small size, the ICG molecule is not caught in the lymph node valve system and keeps migrating when performing lymphography. An exhaustive direct view of the dye path is required to avoid misleading detection of the real sentinel lymph node. This theoretical problem is resolved by the use of the 99mTC-nanocolloid. This tracer gets trapped into the lymph node valve system because of its molecular size and does not keep migrating as does ICG. As such, a combination of both methods is proposed. Laparoscopic performance of sentinel lymph node technique in ovarian cancer seems to achievable. Between 2017 and 2019, this procedure was performed in 30 patients (13 laparoscopic), in the context of our pilot experience [4] and the Sentinel Lymph Node in Early Ovarian Cancer clinical trial (NCT03452982).

Linked Investigators