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

Recruiting

• Conditions: Pancreatic and periampullary cancer

• Registration Number: NL-OMON28591
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

18 years or older;

-Patients with pancreatic or periampullary cancer undergoing resection with curative intent;

Exclusion Criteria

-History of allergy to iodine, shellfish or ICG;

-Pregnant or lactating woman;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Percentage of averted laparotomies.

Secondary Outcome Measures

Name	Time	Method
-Sensitivity and positive predictive value of laparoscopic inspection vs. LUS vs. NIR fluorescence imaging vs. histopathological examination.<br /><br>-Positive and negative predictive value of LUS vs. NIR fluorescence imaging 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>