## Protocol Section
### Identification Module
**NCT ID:** NCT03984279

**Acronym:** APIR-TDM

**Brief Title:** Comparison of Sequential Fluoroscopy Guidance With Spiral Guidance in Terms of Safety, Effectiveness, Speed and Radiation in Interventional Chest-abdomen-pelvic Procedures

**Official Title:** Comparison of the Study Was to Compare Sequential Fluoroscopy Guidance With Spiral Guidance in Terms of Safety (Number of Major Complications), Effectiveness (Number of Targets Reached), Speed (Procedural Time) and Radiation (DLP) in Interventional Chest-abdomen-pelvic Procedures.

#### Organization Study ID Info
**ID:** P/2018/362
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Besancon
### Status Module
#### Completion Date
**Date:** 2018-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-07-23

**Type:** ACTUAL

**Last Update Submit Date:** 2019-07-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2018-01-17

**Type:** ACTUAL

**Status Verified Date:** 2019-05

#### Study First Post Date
**Date:** 2019-06-12
**Type:** ACTUAL
**Study First Submit Date:** 2019-05-27
**Study First Submit QC Date:** 2019-06-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire de Besancon

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of the study was to compare sequential fluoroscopy guidance with spiral guidance in terms of safety (number of major complications), effectiveness (number of targets reached), speed (procedural time) and radiation (DLP) in interventional chest-abdomen-pelvic procedures.

### Conditions Module

**Conditions:**

- Body Interventional procédures With CT

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 385

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control

**Label:** Sequentiel group (SEQ)

#### Arm Group 2

**Intervention Names:**

- Other: Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control

**Label:** Siral group (SPI)

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sequentiel group (SEQ)

- Siral group (SPI)

**Description:** Not applicable, all patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control on a period of 1 year will be taken into account

**Name:** Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Comparison between the 2 groups

**Measure:** number of major complications

**Time Frame:** All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account

**Description:** Comparison between the 2 groups

**Measure:** number of targets reached

**Time Frame:** All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account

**Description:** Comparison between the 2 groups

**Measure:** Dose Length Product (DLP)

**Time Frame:** All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account

#### Secondary Outcomes

**Description:** Comparison between the 2 groups

**Measure:** number of controls required to place the needle

**Time Frame:** All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* adult patients (\> 18 years),
* indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control

Exclusion Criteria:

* MRI contra indication
* persons referred to in Articles L1121-5 to L1121-8 of the French Public Health Code

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patient with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Besançon

**Country:** France

**Facility:** Centre Hospitalier Universitaire

**Zip:** 25000

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
