Accuracy of Coplanar Template Assistance for Abdominal Tumor Puncture

• Conditions: Abdominal Tumor

• Registration Number: NCT05408819
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-22
• Study First Submitted QC: 2022-06-05
• Study First Posted: 2022-06-07
• Study Start: 2022-06-10
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19
• Primary Completion: 2024-02-10
• Study Completion: 2024-02-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of Angle	during the operation	Angle (degree) difference between actual puncture and planned puncture pathway
Accuracy of Depth	during the operation	Depth (millimeter) difference between actual puncture and planned puncture pathway

Secondary Outcome Measures

Name	Time	Method
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
Success rate of needle puncture	during the operation	Success rate of needle puncture
Number of CT scans	during the operation	Number of CT scans

Trial Locations

Locations (1)

Department of Radiation Oncology of Peking university third hospital; 🇨🇳 Beijing, China