Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
226 participants
INTERVENTIONAL
2014-06-15
2021-12-31
Brief Summary
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Detailed Description
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Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers.
Technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated.
An interim analyse will be performed after 34 node positive patients based on the Fleming two stage analyse. The null hypothesis of sensitivity of 85% will be tested against an estimated sensitivity of 95%. At this stage the study may be closed for futility, closed as hull hypothesis is rejected or continued to reach another 28 node positive patients.
As a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient will act ast their own controls.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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prospective cohort study
Prospective cohort study with detection of sentinel lymph nodes followed by a full pelvic lymphadenectomy. Patients will act as their own controls.
The intervention is the detection and removal of sentinel lymph nodes
Sentinel node detection in cervical cancer
The study intervention is the injection of tracer followed by detection and removal of sentinel lymph nodes
Interventions
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Sentinel node detection in cervical cancer
The study intervention is the injection of tracer followed by detection and removal of sentinel lymph nodes
Eligibility Criteria
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Inclusion Criteria
* Women with a pathologically proven cervical carcinoma of any histologic subtype, clinically stage 1a2- 2a1 planned for primary surgery
Exclusion Criteria
* Ongoing pregnancy
* Inability to understand written and/or oral study information
* Who performance status III or more
* Previous lower limb lymphedema
* Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.
* Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion
* Locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography
* Radiologically suspect pelvic nodal metastatic disease according to the RECIST criteria (\>= 1 node with \>=16 mm short axis diameter)
* Allergy to Iodine
* Patients with a known liver disease
* Patients with a significant bleeding disorder or mandatory antithrombotic treatment.
18 Years
80 Years
FEMALE
No
Sponsors
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Region Skane
OTHER
Responsible Party
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Principal Investigators
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Jan Persson, ass professor
Role: PRINCIPAL_INVESTIGATOR
Region Skane
Locations
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Department of Gynecology and Obstetrics
Lund, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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RegionSkaneKKLund2
Identifier Type: -
Identifier Source: org_study_id
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