Clinical trial NCT05408819: Accuracy of Coplanar Template Assistance for Abdominal Tumor Puncture
Official title: A Prospective Study on Accuracy and Safety of Coplanar Template Assisted CT-guided Abdominal Tumor Biopsy and Fiducial Marker Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Tumor
Keywords: abdominal tumor
biopsy
fiducial marker
coplanar template
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive eligible patient with single or multiple abdominal tumors or mass, who are planned undergo biopsy and/or fiducial marker implantation with applicable puncture path in Peking university Third hospital will be enrolled.

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 actual operation, which is conducive to the 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 abdominal tumor puncture during biopsy and fiducial markers implantation.


Eligibility criteria: Inclusion Criteria:

1. Ages 18 to 85
2. Single or multiple abdominal tumors or 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)
4. KPS\>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
5. Planned biopsy and/or fiducial marker implantation with applicable puncture path
6. With informed consent.

Exclusion Criteria:

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, unable to complete coordination
4. Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.

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: Department of Radiation Oncology of Peking university third hospital
Study officials:
affiliation: Peking University Third Hospital
name: Wang Junjie
role: PRINCIPAL_INVESTIGATOR
References: