Staging laparoscopy combined with ultrasonography and near-infrared fluorescence imaging to detect occult pancreatic metastases

Phase 2

Completed

Conditions: Pancreatic cancer metastases
secondary malignancies
10014705

Registration Number: NL-OMON43841

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

- 18 years or older;
- Patients with pancreatic or periampullary cancer undergoing staging laparoscopy
- Absence of any psychological, familial sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
- Before patient registration, written consent must be given according to ICH/GCP, national and local regulations.

Exclusion Criteria

- History of allergy to iodine, shellfish or ICG;
- Renal impairment, defined as eGFR > 60;
- Patients with hyperthyroidism;
- Pregnant or lactating woman;
- Any condition that in the opinion of the investigator could potentially jeopardize the health status of the patient.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Percentage of averted laparotomies.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Sensitivity and positive predictive value of laparoscopic inspection vs. LUS<br /><br>vs. NIR fluorescence imaging vs. histopathological examination.<br /><br>- Positive and negative predictive value of LUS vs. NIR fluorescence imaging<br /><br>on the occurrence of distant metastases.<br /><br>- Distant disease-free survival (occurrence of distant metastases)<br /><br>- Overall survival<br /><br>- Perioperative morbidity and mortality.<br /><br>- Duration of surgical procedures.<br /><br>- Quality of life (EORTC QLQ-C30 taken during standard planned outpatient<br /><br>clinic visits every 3 months).</p><br>