Accuracy of Coplanar Template Assistance for Abdominal Tumor Puncture

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Study on Accuracy and Safety of Coplanar Template Assisted CT-guided Abdominal Tumor Biopsy and Fiducial Marker Implantation

Conditions
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Abdominal Tumor

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18 to 85 Single or multiple abdominal tumors or mass (solid, partially solid) 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) KPS>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture Planned biopsy and/or fiducial marker implantation with applicable puncture path With informed consent. Exclusion Criteria: Poor organ function (e.g. lung function FEV1<40% and/or DLCO<50%) 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 Poor compliance, unable to complete coordination Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coplanar Template group<br>Paticipant will undergo coplanar template assisted CT-guided abdominal tumor biopsy or fiducial markers implantation and the prospective accuracy and safety data will record. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Depth | Depth (millimeter) difference between actual puncture and planned puncture pathway | during the operation | 
| Accuracy of Angle | Angle (degree) difference between actual puncture and planned puncture pathway | during the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of needle puncture | Success rate of needle puncture | during the operation | 
| Complication rate | such as pneumoperitoneum, subcutaneous emphysema, hemorrhage, infection, etc. | perioperative the operation | 
| operating duration | operating duration from the starting to the ending | during the operation | 
| Number of CT scans | Number of CT scans | during the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal tumor, biopsy, fiducial marker, coplanar template