Accuracy of Coplanar Template Assistance for Abdominal Tumor Puncture

Peking University

Status: Enrolling

Conditions: Abdominal Tumor

Study type: Observational

Funder types: Other

Identifiers

NCT05408819

ChiECRCT20220035

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

50 participants in 1 patient group

Coplanar Template group

Description:

Paticipant will undergo coplanar template assisted CT-guided abdominal tumor biopsy or fiducial markers implantation and the prospective accuracy and safety data will record.