Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer

Peking University Third Hospital34 enrolled

Overview

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 previous studies, coplanar template assisted CT-guided radioactive seed implantation has good clinical feasibility for head and neck cancer. However, the accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic cancer are lacking in prospective studies. The study aims to prospectively observe the accuracy and safety of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic cancer.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Ages 18 to 85 2. Single or multiple abdominal or pelvic tumors (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 with expected survival \>3 months, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture 5. Planned seed implantation with applicable puncture path 6. With informed consent. Exclusion Criteria: 1. Poor organ function (e.g. Liver decompensation) 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.

Outcomes

Primary Outcomes

Dosimetry (D90) between pre-plan and post-plan

Dose covering 90% of target volume between pre-plan and post-plan

Time frame: From the starting to the ending of the seed implantation (generally within 1 week).

Secondary Outcomes

Success rate of seed implantation

Time frame: From the starting to the ending of the seed implantation (generally within 1 day).

Adverse event

Such as pneumoperitoneum, subcutaneous emphysema, hemorrhage, infection, etc.

Time frame: Acute adverse event is defined as 1 month after seed implantation and beyond 1 month for chronic adverse event.

Operating duration

Operating duration from the starting to the ending

Time frame: From the starting to the ending of the seed implantation (generally within 2 hours)

Local progression-free survival

Local progression-free survival:Duration of the seed implantation to local tumor progression

Time frame: From date of seed implantation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts