Clinical trial NCT05419141: Accuracy of Coplanar Template Assistance for Pelvic and Groin Areas Biopsy
Official title: A Prospective Study on Accuracy and Safety of Coplanar Template Assisted CT-guided Pelvic and Groin Areas Biopsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic and Groin Areas Biopsy
Keywords: Pelvic
Groin
Biopsy
Coplanar template.
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Poor organ function (e.g. lung function FEV1\<40% and/or DLCO\<50%)
2. The lesion close to blood vessels and intestine, or there is portal vein hypertension and superior vena cava compression, etc., which are expected to have high risks of puncture bleeding and intestinal injury
3. Poor compliance and unable to complete coordination
4. Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.

Brief summary: In recent years, template guidance has been applied and developed in the field of puncture related operations, such as template-assisted radioactive seed implantation. With the guidance of template, needle pathway of seed implantation, biopsy and fiducial marker implantation can be precisely planned

, which is conducive to accurate proceeding. Templates can be divided into coplanar templates and non-coplanar templates. The digital coplanar template coordinate puncture system has been developed in China and has been applied in clinical practice. In our previous studies, coplanar template assisted CT-guided radioactive seed implantation has good clinical feasibility for percutaneous biopsy of small pulmonary nodules. However, the accuracy of coplanar template assistance for abdominal tumor puncture are lacking in prospective studies. The study aims to prospectively observe the accuracy and safety of coplanar template assisted CT-guided Pelvic and Groin Areas biopsy.


Eligibility criteria: Inclusion Criteria:

1. Ages 18 to 90
2. Single or multiple Pelvic and Groin Areas mass (solid, partially solid)
3. Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week)

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4. KPS\>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
5. Planned biopsy with applicable puncture path
6. With informed consent.

Exclusion Criteria:

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Primary outcomes:
measure: Accuracy of Depth
timeFrame: during the operation
measure: Accuracy of Angle
timeFrame: during the operation
Secondary outcomes:
measure: Success rate of needle puncture
timeFrame: during the operation
measure: Complication rate
timeFrame: perioperative the operation
measure: operating duration
timeFrame: during the operation
measure: Number of CT scans
timeFrame: during the operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Bin Qiu, M.D.
Study officials:
References: