An alternative for guide-wire localisation might be the use of radio-active seed (I-125) implantation. This marker can easily be identified by means of a gamma-probe. This radio-active seeds are cilindric capsules (approximately 4 mm with a diameter…
ID
Source
Brief title
Condition
- Other condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Health condition
intrathoracaal (en intraparenchymaal) gelegen longafwijkingen (benigne en maligne)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peroperative localisation
Secondary outcome
Implant procedure
Pathological analysis
Background summary
In some lung lesions it may be necessary to obtain a histological biopsy. When
transthoracal punction and EUS (endoscopic ultrasound)/EBUS (endobronchial
ultrasound) fail to obtain a diagnose a surgical biopsy is the next step. Often
a VATS (video assisted thoracoscopic surgery) is used for biopsy. When the lung
lesion is localized intraparenchymale and thus not visible during VATS, there
is a need to localize the lesion. Mostly the localisation is performed using a
guide-wire. Short before surgery this guide-wire is placed by the pulmonologist
and/or radiologist. This procedure has some disadvantages of which the most
important one is dislocation of the guide-wire due to desoufflation of the
lung. In some cases there is a need to convert to thoracotomy to localize the
lesion. Even then, localisation can be difficult. Other problems which can
occur are punction pneumothorax and logistic problems.
Study objective
An alternative for guide-wire localisation might be the use of radio-active
seed (I-125) implantation. This marker can easily be identified by means of a
gamma-probe. This radio-active seeds are cilindric capsules (approximately 4 mm
with a diameter of 0.8 mm), which exists of a titaniumcapsule with radio-active
Jodium-125 (I-125).
I-125 is used in breast cancer surgery for several years. Main indications are
localisation of non-palpable lesions, lesions treated with neo-adjuvant
chemotherapy (NAC) with a possibility for pCR (complete pathological respons)
and in large breast lesions (treated by breast-conserving-therapy) with a need
for landmarking.
The main advantage of the use of I-125 markers is the fact that implnated seeds
do not migrate or dislocate. Thereby providing a reliable localisation.
Further, the radio-active seeds can be implanted some time before surgery, to
overcome logistical problems.
The disadvantage of localisation, as with guide-wire placement, is the risk for
punction pneumothorax.
Study design
Patients in whom the pulmonologist indicated the need for surgical biopsy by
means of VATS.
In stead of guide-wire placement and localisation a I-125 marker is placed:
- The pulmonologist decides the indication.
- The pulmonologist and radiologist do implant teh I-125 marker with a punction
needle (under auspicien of the nucleair medicine specialist).
- The surgeon localises the I-125 marker by means of a probe during VATS and
takes a biopsy.
- The pathologist removes the I-125 marker (conform the local protocol, under
auspicien of the nucleair medicine specialist) and analyses the lesion.
Intervention
Implant of a I-125 marker (radio-active seed).
Study burden and risks
No increase of burden and risk compared to the common implant technique
(guide-wire)
Molengracht 21
4818 CK
NL
Molengracht 21
4818 CK
NL
Listed location countries
Age
Inclusion criteria
Lung lesion wthout a diagnosis with an indication for surgical biopsy
Exclusion criteria
No exclusion criteria
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL36464.008.11 |