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


- candidate number27707
- NTR NumberNTR6639
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-jul-2017
- Secondary IDsP10.001 Commissie Medische Ethiek van het LUMC
- Public TitleStaging laparoscopy combined with ultrasonography and near-infrared fluorescence imaging to detect occult pancreatic metastases
- Scientific TitleStaging laparoscopy combined with ultrasonography and near-infrared fluorescence imaging to detect occult pancreatic metastases
- ACRONYM
- hypothesisThe yield of staging laparoscopy will be increased by adding laparoscopic ultrasound and laparoscopic near-infrared fluorescence imaging.
- Healt Condition(s) or Problem(s) studiedPancreas tumor, Periampullary tumor
- Inclusion criteria- 18 years or older;
- Patients with pancreatic or periampullary cancer undergoing resection with curative intent;
- Stage 2A or higher; or tumor sized 3 cm or more;
- 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;
- Pregnant or lactating woman;
- Any condition that in the opinion of the investigator could potentially jeopardize the health status of the patient.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2016
- planned closingdate31-dec-2017
- Target number of participants25
- InterventionsIn addition to standard-of-care, patients will receive an intravenous injection of 10 mg ICG 1-3 days prior to surgery. During surgery, patients undergo a SL, whereupon inspection, LUS and NIR fluorescence imaging will be performed. A biopsy will be taken from any suspect lesions. Decision to continue the resection is up to the surgeon. Follow-up will last at least 6 months.
- Primary outcome- Percentage of averted laparotomies.
- Secondary outcome- Sensitivity and positive predictive value of laparoscopic inspection vs. LUS vs. NIR fluorescence imaging vs. histopathological examination.
- Positive and negative predictive value of LUS vs. NIR fluorescence imaging on the occurrence of distant metastases.
- Distant disease-free survival (occurrence of distant metastases)
- Overall survival
- Perioperative morbidity and mortality.
- Duration of surgical procedures.
- Timepoints3 months follow-up
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD Sven Mieog
- CONTACT for SCIENTIFIC QUERIESMD, PhD Sven Mieog
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society
- Publications
- Brief summaryEven after extensive preoperative assessment, up to 38% of patients undergoing laparotomy with curative intent turn out to have metastases or unresectable disease, preventing curative surgery. Moreover, a substantial number of patients present shortly after surgery with liver metastases that must have been present during surgery, but have not been identified. SL combined with LUS and NIR fluorescence imaging may identify metastases and unresectable disease, sparing patients with incurable disease the morbidity, inconvenience and expense of a futile operation. Staging laparoscopy in pancreatic cancer patients is being advocated in literature, but has not yet been implemented in clinical guidelines.This is a phase II single center, single-arm trial to assess the added value of staging laparoscopy (SL), laparoscopic ultrasonography (LUS) and near-infrared (NIR) fluorescence imaging in patients with pancreatic cancer undergoing resection with curative intent.
- Main changes (audit trail)
- RECORD31-jul-2017 - 27-aug-2017


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