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Hypothesis: Use of contrast ultrasound showed interesting results, which can increase ultrasonography sensitivity performed during surgery in the evaluation of operable liver metastases.
This study is a two-stage phase II multicenter study (Simon's two-stage).
Hypothesis: Use of contrast ultrasound showed interesting results, which can increase ultrasonography sensitivity performed during surgery in the evaluation of operable liver metastases.
This study is a two-stage phase II multicenter study (Simon's two-stage).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contrast-enhanced intraoperative ultrasound | Other | Contrast-enhanced intraoperative ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-enhanced intraoperative ultrasound | Device | Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment: Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases. | The clinical utility will be evaluated in terms of justified modification of the surgical procedure following contrast-enhanced intra-operative ultrasound (CE-IOUS), compared to the surgical procedure following conventional intra-operative ultrasound. For each patient, we will consider CE-IOUS to be clinically useful:
| At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Utility of CE-IOUS in Subgroup of Patients Who Received Preoperative Chemotherapy | The primary endpoint will be assessed in the subgroup of patients who received preoperative chemotherapy. As for the primary outcome, the clinical utility is evaluated in terms of justified modification of the surgical gesture envisaged following CE-IOUS, compared to the surgical gesture envisaged following a conventional intraoperative ultrasound. We reported the percentage of patients for whom there was a modified and justified surgical gesture following CE-IOUS in the subgroup of patients who received preoperative chemotherapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| EVRARD Serge, PU-PH | Institut Bergonié | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | Aquitaine | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30879929 | Background | Desolneux G, Isambert M, Mathoulin-Pelissier S, Dupre A, Rivoire M, Cattena V, Palussiere J, Dinart D, Bellera C, Evrard S. Contrast-enhanced intra-operative ultrasound as a clinical decision making tool during surgery for colorectal liver metastases: The ULIIS study. Eur J Surg Oncol. 2019 Jul;45(7):1212-1218. doi: 10.1016/j.ejso.2019.03.002. Epub 2019 Mar 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Contrast-enhanced Intraoperative Ultrasound | Contrast-enhanced intraoperative ultrasound Contrast-enhanced intraoperative ultrasound: Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment: Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Contrast-enhanced Intraoperative Ultrasound | Contrast-enhanced intraoperative ultrasound Contrast-enhanced intraoperative ultrasound: Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment: Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases. | The clinical utility will be evaluated in terms of justified modification of the surgical procedure following contrast-enhanced intra-operative ultrasound (CE-IOUS), compared to the surgical procedure following conventional intra-operative ultrasound. For each patient, we will consider CE-IOUS to be clinically useful:
| We used a 2-stage Simon's design with the following assumptions:
Second stage: CE-IOUS clinically useful if the planned surgical procedure is modified and justified for 5 or more patients (9.6%). | Posted | Number | 95% Confidence Interval | percentage of patients | At time of surgery |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Contrast-enhanced Intraoperative Ultrasound | Contrast-enhanced intraoperative ultrasound Contrast-enhanced intraoperative ultrasound: Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment: Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonitis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Derek Dinart | Institut Bergonie | d.dinart@bordeaux.unicancer.fr |
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|
| at time of surgery |
| Performance Evaluation of Intraoperative Ultrasound Contrast: Detection Rate Per Lesion | Detection of malignant lesions by CE-IOUS in chemotherapy-free patients within 3 post-operative months. The detection rate is defined as the proportion of malignant lesions for which there is concordance between the diagnosis established by CE-IOUS and the reference examination. | up to 3 months after surgery |
| Description of Technical Arrangements for the CE-IOUS | Description of technical arrangements for the CE-IOUS duration. The length of time during which contrast injection was useable. | At time of contrast-enhanced IOUS |
| Performance Evaluation of Intraoperative Ultrasound Contrast Per Lesion: Characterisation Rate | Characterisation rate for focal liver lesions: the proportion of lesions whose nature on CE-IOUS is identical to the nature of the lesions defined by the reference examinations among all the lesions seen on CE-IOUS (malignant and benign) | up to 3 months after surgery |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Cancer localization | Count of Participants | Participants |
|
| Liver metastases | Count of Participants | Participants |
|
|
|
|
| Secondary | Clinical Utility of CE-IOUS in Subgroup of Patients Who Received Preoperative Chemotherapy | The primary endpoint will be assessed in the subgroup of patients who received preoperative chemotherapy. As for the primary outcome, the clinical utility is evaluated in terms of justified modification of the surgical gesture envisaged following CE-IOUS, compared to the surgical gesture envisaged following a conventional intraoperative ultrasound. We reported the percentage of patients for whom there was a modified and justified surgical gesture following CE-IOUS in the subgroup of patients who received preoperative chemotherapy. | Subgroup of patients with preoperative chemotherapy | Posted | Number | 95% Confidence Interval | percentage of patients | at time of surgery |
|
|
|
| Secondary | Performance Evaluation of Intraoperative Ultrasound Contrast: Detection Rate Per Lesion | Detection of malignant lesions by CE-IOUS in chemotherapy-free patients within 3 post-operative months. The detection rate is defined as the proportion of malignant lesions for which there is concordance between the diagnosis established by CE-IOUS and the reference examination. | There were 22 (40.7%) out of 54 chemotherapy-free patients within 3 post-operative months | Posted | Number | proportion of lesions | up to 3 months after surgery |
|
|
|
| Secondary | Description of Technical Arrangements for the CE-IOUS | Description of technical arrangements for the CE-IOUS duration. The length of time during which contrast injection was useable. | Posted | Median | Full Range | seconds | At time of contrast-enhanced IOUS |
|
|
|
| Secondary | Performance Evaluation of Intraoperative Ultrasound Contrast Per Lesion: Characterisation Rate | Characterisation rate for focal liver lesions: the proportion of lesions whose nature on CE-IOUS is identical to the nature of the lesions defined by the reference examinations among all the lesions seen on CE-IOUS (malignant and benign) | Posted | Number | proportion of lesions | up to 3 months after surgery |
|
|
|
| 11 |
| 54 |
| 2 |
| 54 |
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Eventration | Surgical and medical procedures | Systematic Assessment |
|
| Biliary fistula | Hepatobiliary disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bile collection secondary to a biliary tract wound | Hepatobiliary disorders | Systematic Assessment |
|
| Fistule anastomose colorectale | Gastrointestinal disorders | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | Systematic Assessment |
|
| Peri-hepatic Blood Collection | Vascular disorders | Systematic Assessment |
|
| Stercoral peritonitis | Infections and infestations | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Right cry | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Hepatocellular insufficiency | Hepatobiliary disorders | Systematic Assessment |
|
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