Accuracy of Coplanar Template Assistance for Abdominal Tumor Puncture

NCT05408819 | Unknown

• 1 other identifier: ChiECRCT20220035
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Tumor

Keywords

abdominal tumor; biopsy; fiducial marker; coplanar template

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Success rate of needle puncture

  during the operation

• Complication rate

  perioperative the operation

• operating duration

  during the operation

• Number of CT scans

  during the operation

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Ages 18 to 85
• Single or multiple abdominal tumors or mass (solid, partially solid)
• 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)
• KPS\>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
• Planned biopsy and/or fiducial marker implantation with applicable puncture path
• With informed consent.

You may not qualify if:

• Poor organ function (e.g. lung function FEV1\<40% and/or DLCO\<50%)
• 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
• Poor compliance, unable to complete coordination
• Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Department of Radiation Oncology of Peking university third hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Abdominal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Wang Junjie

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Qiu, M.D.

CONTACT

01082265968; 542122203@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2022
• First Posted: June 7, 2022
• Study Start: June 10, 2022
• Primary Completion: February 10, 2024
• Study Completion: February 10, 2024
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

CN (1)