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

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Tumor

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Bin Qiu, M.D.; Phone Number: 01082265968; Email: 542122203@qq.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Department of Radiation Oncology of Peking university third hospital
    • Contact: Bin Qiu; Phone Number: 01082265968; Email: 542122203@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Coplanar Template group; 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?

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Wang Junjie, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Anticipated): February 10, 2024
• Study Completion (Anticipated): February 10, 2024

Study Registration Dates

• First Submitted: May 22, 2022
• First Submitted That Met QC Criteria: June 5, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: biopsy; fiducial marker; abdominal tumor; coplanar template
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Abdominal Neoplasms
• Other Study ID Numbers: ChiECRCT20220035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No