Accuracy of Coplanar Template Assistance for Pelvic and Groin Areas Biopsy

A Prospective Study on Accuracy and Safety of Coplanar Template Assisted CT-guided Pelvic and Groin Areas Biopsy

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

, which is conducive to 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 Pelvic and Groin Areas biopsy.

Study Overview

• Status: Recruiting
• Conditions: Pelvic and Groin Areas Biopsy

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Not yet recruiting
    • Bin Qiu, M.D.
    • Contact: Bin Qiu; Phone Number: 01082265968; Email: 542122203@qq.com
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking University Third Hospital
      • Contact: Bin Qiu, M.D.; Phone Number: 01082265968; Email: 542122203@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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 and unable to complete coordination
4. Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.

Description

Inclusion Criteria:

1. Ages 18 to 90
2. Single or multiple Pelvic and Groin Areas 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)

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4. KPS>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
5. Planned biopsy with applicable puncture path
6. With informed consent.

Exclusion Criteria:

-

Study Plan

How is the study designed?

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

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Anticipated): June 20, 2024
• Study Completion (Anticipated): June 20, 2024

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 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; Groin; Pelvic; Coplanar template.
• Other Study ID Numbers: ChiECRCT20220127

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