Accuracy of Coplanar Template Assistance for Abdominal Tumor Puncture

Abdominal Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05408819
• Other study ID #: ChiECRCT20220035
• Status: Recruiting
• Start date: June 10, 2022
• Est. completion date: February 10, 2024

Study information

• Verified date: July 2022
• Source: Peking University Third Hospital
• Contact: Bin Qiu, M.D.
• Phone: 01082265968
• Email: 542122203[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 10, 2024
• Est. primary completion date: February 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Neoplasms
• Abdominal Tumor

Locations

Country	Name	City	State
China	Department of Radiation Oncology of Peking university third hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Depth	Depth (millimeter) difference between actual puncture and planned puncture pathway	during the operation
Primary	Accuracy of Angle	Angle (degree) difference between actual puncture and planned puncture pathway	during the operation
Secondary	Success rate of needle puncture	Success rate of needle puncture	during the operation
Secondary	Complication rate	such as pneumoperitoneum, subcutaneous emphysema, hemorrhage, infection, etc.	perioperative the operation
Secondary	operating duration	operating duration from the starting to the ending	during the operation
Secondary	Number of CT scans	Number of CT scans	during the operation