Accuracy of Coplanar Template Assistance for Abdominal Tumor Puncture

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05408819

Enrollment

Registered

2022-06-07

Start date

2022-06-10

Completion date

2024-02-10

Last updated

2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Tumor

Keywords

abdominal tumor, biopsy, fiducial marker, coplanar template

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactBin Qiu, M.D.

542122203@qq.com01082265968

Outcome results